entimo news archive
entimo has a long history, This is it.
2019
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Release of entimICE® FastTrack 3.1 strengthens integration
01-01-2025
Just weeks after the 3.0 release, entimo has updated its integrated CDR/SCE entimICE FastTrack to version 3.1. System users now can benefit from additional interfaces, including connections to Veeva Vault EDC, Posit Workbench and Lixoft Monolix/Simulx. The new interfaces facilitate data processing, standardization and transformation with these third-party tools, providing another level of R/Python Open Source tool integration. Management of study deliverables has been improved with capabilities to assign and track tasks and monitor validation progress towards study completion, while the associated reports can be filtered, customized and exported. Additionally, it is now possible to subscribe to notifications in areas or specific folders of interest, and the system supports import and export of zipped archives. entimo’s customers can thus accelerate their clinical development towards on-time successful submissions. -
entimo at the PHUSE Computational Science Symposium
01-01-2025
entimo participated in the PHUSE Computational Science Symposium (CSS), held June 3-5, 2024 in Silver Spring, Maryland, USA. entimo proudly supported the event and sponsored the poster session. PHUSE CSS is a unique opportunity for an open exchange between the biopharma industry and regulatory authorities, helping to shape the future of clinical data science, and to accelerate regulatory submissions and approvals for new life-saving medicines. Our team is excited to see how CDISC, PHUSE and the FDA are collaborating on the Dataset JSON pilot, and we brought home many fresh ideas for our product development department. A complete review of the event is available on the PHUSE website. -
entimo Enters Posit Reseller Agreement
01-01-2025
Entimo AG and Posit PBC officially entered a reseller agreement on March 28th, 2024. This enables entimo to provide entimICE FastTrack, the cloud-based Clinical Data Repository and Statistical Computing Environment, in combination with Posit Workbench, Posit Connect and Posit Package Manager as a bundled Software as a Service offer to pharmaceutical, biotech and CRO customers. Entimo AG is known for providing truly language-agnostic and regulatory compliant solutions for clinical data management and statistical analysis to the industry, scaling from biometrics departments of ten members up to data science teams within global enterprises with thousands of users. Posit PBC has taken R, R Shiny and Python to the next level for statistical analysis by providing feature-rich products to manage program development, app deployment, and access and enterprise package management. The bundled offer of entimICE FastTrack and the customer's choice of Posit products provides a cloud-based turnkey solution for regulatory and exploratory analysis in clinical trials. -
entimICE® FastTrack 3.0 release
01-01-2025
entimo has released version 3.0 of its integrated SCE/CDR solution. entimICE FastTrack in its latest version now provides automated program run sequences, durable object properties providing metadata information for up- and downstream processes or references to central libraries and standards, as well as integration with Pinnacle 21 Enterprise. Users benefit from comprehensive deliverable snapshots, improved security features, new system reports, and much more. With this latest version of FastTrack, clinical data science receives a significant boost towards faster and successful submissions.
2018
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Release of entimICE® FastTrack 3.1 strengthens integration
01-01-2025
Just weeks after the 3.0 release, entimo has updated its integrated CDR/SCE entimICE FastTrack to version 3.1. System users now can benefit from additional interfaces, including connections to Veeva Vault EDC, Posit Workbench and Lixoft Monolix/Simulx. The new interfaces facilitate data processing, standardization and transformation with these third-party tools, providing another level of R/Python Open Source tool integration. Management of study deliverables has been improved with capabilities to assign and track tasks and monitor validation progress towards study completion, while the associated reports can be filtered, customized and exported. Additionally, it is now possible to subscribe to notifications in areas or specific folders of interest, and the system supports import and export of zipped archives. entimo’s customers can thus accelerate their clinical development towards on-time successful submissions. -
entimo at the PHUSE Computational Science Symposium
01-01-2025
entimo participated in the PHUSE Computational Science Symposium (CSS), held June 3-5, 2024 in Silver Spring, Maryland, USA. entimo proudly supported the event and sponsored the poster session. PHUSE CSS is a unique opportunity for an open exchange between the biopharma industry and regulatory authorities, helping to shape the future of clinical data science, and to accelerate regulatory submissions and approvals for new life-saving medicines. Our team is excited to see how CDISC, PHUSE and the FDA are collaborating on the Dataset JSON pilot, and we brought home many fresh ideas for our product development department. A complete review of the event is available on the PHUSE website. -
entimo Enters Posit Reseller Agreement
01-01-2025
Entimo AG and Posit PBC officially entered a reseller agreement on March 28th, 2024. This enables entimo to provide entimICE FastTrack, the cloud-based Clinical Data Repository and Statistical Computing Environment, in combination with Posit Workbench, Posit Connect and Posit Package Manager as a bundled Software as a Service offer to pharmaceutical, biotech and CRO customers. Entimo AG is known for providing truly language-agnostic and regulatory compliant solutions for clinical data management and statistical analysis to the industry, scaling from biometrics departments of ten members up to data science teams within global enterprises with thousands of users. Posit PBC has taken R, R Shiny and Python to the next level for statistical analysis by providing feature-rich products to manage program development, app deployment, and access and enterprise package management. The bundled offer of entimICE FastTrack and the customer's choice of Posit products provides a cloud-based turnkey solution for regulatory and exploratory analysis in clinical trials. -
entimICE® FastTrack 3.0 release
01-01-2025
entimo has released version 3.0 of its integrated SCE/CDR solution. entimICE FastTrack in its latest version now provides automated program run sequences, durable object properties providing metadata information for up- and downstream processes or references to central libraries and standards, as well as integration with Pinnacle 21 Enterprise. Users benefit from comprehensive deliverable snapshots, improved security features, new system reports, and much more. With this latest version of FastTrack, clinical data science receives a significant boost towards faster and successful submissions.
2017
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Release of entimICE® FastTrack 3.1 strengthens integration
01-01-2025
Just weeks after the 3.0 release, entimo has updated its integrated CDR/SCE entimICE FastTrack to version 3.1. System users now can benefit from additional interfaces, including connections to Veeva Vault EDC, Posit Workbench and Lixoft Monolix/Simulx. The new interfaces facilitate data processing, standardization and transformation with these third-party tools, providing another level of R/Python Open Source tool integration. Management of study deliverables has been improved with capabilities to assign and track tasks and monitor validation progress towards study completion, while the associated reports can be filtered, customized and exported. Additionally, it is now possible to subscribe to notifications in areas or specific folders of interest, and the system supports import and export of zipped archives. entimo’s customers can thus accelerate their clinical development towards on-time successful submissions. -
entimo at the PHUSE Computational Science Symposium
01-01-2025
entimo participated in the PHUSE Computational Science Symposium (CSS), held June 3-5, 2024 in Silver Spring, Maryland, USA. entimo proudly supported the event and sponsored the poster session. PHUSE CSS is a unique opportunity for an open exchange between the biopharma industry and regulatory authorities, helping to shape the future of clinical data science, and to accelerate regulatory submissions and approvals for new life-saving medicines. Our team is excited to see how CDISC, PHUSE and the FDA are collaborating on the Dataset JSON pilot, and we brought home many fresh ideas for our product development department. A complete review of the event is available on the PHUSE website. -
entimo Enters Posit Reseller Agreement
01-01-2025
Entimo AG and Posit PBC officially entered a reseller agreement on March 28th, 2024. This enables entimo to provide entimICE FastTrack, the cloud-based Clinical Data Repository and Statistical Computing Environment, in combination with Posit Workbench, Posit Connect and Posit Package Manager as a bundled Software as a Service offer to pharmaceutical, biotech and CRO customers. Entimo AG is known for providing truly language-agnostic and regulatory compliant solutions for clinical data management and statistical analysis to the industry, scaling from biometrics departments of ten members up to data science teams within global enterprises with thousands of users. Posit PBC has taken R, R Shiny and Python to the next level for statistical analysis by providing feature-rich products to manage program development, app deployment, and access and enterprise package management. The bundled offer of entimICE FastTrack and the customer's choice of Posit products provides a cloud-based turnkey solution for regulatory and exploratory analysis in clinical trials. -
entimICE® FastTrack 3.0 release
01-01-2025
entimo has released version 3.0 of its integrated SCE/CDR solution. entimICE FastTrack in its latest version now provides automated program run sequences, durable object properties providing metadata information for up- and downstream processes or references to central libraries and standards, as well as integration with Pinnacle 21 Enterprise. Users benefit from comprehensive deliverable snapshots, improved security features, new system reports, and much more. With this latest version of FastTrack, clinical data science receives a significant boost towards faster and successful submissions.
2016
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Release of entimICE® FastTrack 3.1 strengthens integration
01-01-2025
Just weeks after the 3.0 release, entimo has updated its integrated CDR/SCE entimICE FastTrack to version 3.1. System users now can benefit from additional interfaces, including connections to Veeva Vault EDC, Posit Workbench and Lixoft Monolix/Simulx. The new interfaces facilitate data processing, standardization and transformation with these third-party tools, providing another level of R/Python Open Source tool integration. Management of study deliverables has been improved with capabilities to assign and track tasks and monitor validation progress towards study completion, while the associated reports can be filtered, customized and exported. Additionally, it is now possible to subscribe to notifications in areas or specific folders of interest, and the system supports import and export of zipped archives. entimo’s customers can thus accelerate their clinical development towards on-time successful submissions. -
entimo at the PHUSE Computational Science Symposium
01-01-2025
entimo participated in the PHUSE Computational Science Symposium (CSS), held June 3-5, 2024 in Silver Spring, Maryland, USA. entimo proudly supported the event and sponsored the poster session. PHUSE CSS is a unique opportunity for an open exchange between the biopharma industry and regulatory authorities, helping to shape the future of clinical data science, and to accelerate regulatory submissions and approvals for new life-saving medicines. Our team is excited to see how CDISC, PHUSE and the FDA are collaborating on the Dataset JSON pilot, and we brought home many fresh ideas for our product development department. A complete review of the event is available on the PHUSE website. -
entimo Enters Posit Reseller Agreement
01-01-2025
Entimo AG and Posit PBC officially entered a reseller agreement on March 28th, 2024. This enables entimo to provide entimICE FastTrack, the cloud-based Clinical Data Repository and Statistical Computing Environment, in combination with Posit Workbench, Posit Connect and Posit Package Manager as a bundled Software as a Service offer to pharmaceutical, biotech and CRO customers. Entimo AG is known for providing truly language-agnostic and regulatory compliant solutions for clinical data management and statistical analysis to the industry, scaling from biometrics departments of ten members up to data science teams within global enterprises with thousands of users. Posit PBC has taken R, R Shiny and Python to the next level for statistical analysis by providing feature-rich products to manage program development, app deployment, and access and enterprise package management. The bundled offer of entimICE FastTrack and the customer's choice of Posit products provides a cloud-based turnkey solution for regulatory and exploratory analysis in clinical trials. -
entimICE® FastTrack 3.0 release
01-01-2025
entimo has released version 3.0 of its integrated SCE/CDR solution. entimICE FastTrack in its latest version now provides automated program run sequences, durable object properties providing metadata information for up- and downstream processes or references to central libraries and standards, as well as integration with Pinnacle 21 Enterprise. Users benefit from comprehensive deliverable snapshots, improved security features, new system reports, and much more. With this latest version of FastTrack, clinical data science receives a significant boost towards faster and successful submissions.
Like what you see?
For more information on any of these topics, contact entimo and we can tell you much more.
- Details
entimICE® DARE
Success with Data
entimo Integrated Clinical Environment
entimo's flagship product is a modular enterprise software suite for the clinical development process. It consists of a metadata driven Statistical Computing Environment (SCE) with a tightly integrated Clinical Data Repository (CDR) and a Metadata Repository (MDR). entimICE is unrivaled in the market for out of the box functionality and configurability to adjust to evolving customer demands. It provides superior adaptation capabilities, serving different sizes of communities from small teams to enterprise platforms with thousands of users. It offers flexible interfaces to other systems in the IT landscape while always guaranteeing full regulatory compliance within the system.
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Modular enterprise software for clinical development -
Highly configurable and scalable platform
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Fully compliant with regulatory standards
All-in-one solution
Leverage entimICE DARE for
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Enterprise collaboration
- Single Point of Truth
All data, programs and artifacts in one place. Secured and controlled. Accessible and traceable. Direct access for primary and secondary use. No uncontrolled copies.
- Access Control
Flexible role-based permission model, enabling super users to manage permissions for teams without involvement of IT administration. Granular control on any level from global areas down to single objects or even rows and columns in clinical data. Blinding of data is fully supported
- Workflow and Lifecycle Management
Configurable workflows for all objects over all lifecycle stages including simple review processes, double programming, validation forms, all combined with discussion forums for the users involved.
- Notifications
Relevant notifications for pending tasks, finished jobs or subscribed system notifications. They can be directly in the system guiding users to the point of action or delivered to your email inbox.
- Enterprise Search
Granular indexes on all data and metadata in the repository, constantly updated with the most recent changes, allow for powerful searches for information and data throughout the repository. Search definitions and search results are usable individually, can be shared with others, or can be used to trigger automated processes.
- Enterprise Data Access and Exchange
Direct access to the entimICE Data Repository while respecting entimICE DARE user permissions. Enables programmers to work with their preferred tools, data scientists to search and find data, and everyone to work with clinical data in entimICE using its virtual database driver.
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Regulatory compliance
- Single Point of Truth
All data, programs and artifacts in one place. Secured and controlled. Accessible and traceable. Direct access for primary and secondary use. No uncontrolled copies.
- Access Control
Flexible role-based permission model, enabling super users to manage permissions for teams without involvement of IT administration. Granular control on any level from global areas down to single objects or even rows and columns in clinical data. Blinding of data is fully supported
- Workflow and Lifecycle Management
Configurable workflows for all objects over all lifecycle stages including simple review processes, double programming, validation forms, all combined with discussion forums for the users involved.
- Notifications
Relevant notifications for pending tasks, finished jobs or subscribed system notifications. They can be directly in the system guiding users to the point of action or delivered to your email inbox.
- Enterprise Search
Granular indexes on all data and metadata in the repository, constantly updated with the most recent changes, allow for powerful searches for information and data throughout the repository. Search definitions and search results are usable individually, can be shared with others, or can be used to trigger automated processes.
- Enterprise Data Access and Exchange
Direct access to the entimICE Data Repository while respecting entimICE DARE user permissions. Enables programmers to work with their preferred tools, data scientists to search and find data, and everyone to work with clinical data in entimICE using its virtual database driver.
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Metadata management
- Single Point of Truth
All data, programs and artifacts in one place. Secured and controlled. Accessible and traceable. Direct access for primary and secondary use. No uncontrolled copies.
- Access Control
Flexible role-based permission model, enabling super users to manage permissions for teams without involvement of IT administration. Granular control on any level from global areas down to single objects or even rows and columns in clinical data. Blinding of data is fully supported
- Workflow and Lifecycle Management
Configurable workflows for all objects over all lifecycle stages including simple review processes, double programming, validation forms, all combined with discussion forums for the users involved.
- Notifications
Relevant notifications for pending tasks, finished jobs or subscribed system notifications. They can be directly in the system guiding users to the point of action or delivered to your email inbox.
- Enterprise Search
Granular indexes on all data and metadata in the repository, constantly updated with the most recent changes, allow for powerful searches for information and data throughout the repository. Search definitions and search results are usable individually, can be shared with others, or can be used to trigger automated processes.
- Enterprise Data Access and Exchange
Direct access to the entimICE Data Repository while respecting entimICE DARE user permissions. Enables programmers to work with their preferred tools, data scientists to search and find data, and everyone to work with clinical data in entimICE using its virtual database driver.
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Data management
- Single Point of Truth
All data, programs and artifacts in one place. Secured and controlled. Accessible and traceable. Direct access for primary and secondary use. No uncontrolled copies.
- Access Control
Flexible role-based permission model, enabling super users to manage permissions for teams without involvement of IT administration. Granular control on any level from global areas down to single objects or even rows and columns in clinical data. Blinding of data is fully supported
- Workflow and Lifecycle Management
Configurable workflows for all objects over all lifecycle stages including simple review processes, double programming, validation forms, all combined with discussion forums for the users involved.
- Notifications
Relevant notifications for pending tasks, finished jobs or subscribed system notifications. They can be directly in the system guiding users to the point of action or delivered to your email inbox.
- Enterprise Search
Granular indexes on all data and metadata in the repository, constantly updated with the most recent changes, allow for powerful searches for information and data throughout the repository. Search definitions and search results are usable individually, can be shared with others, or can be used to trigger automated processes.
- Enterprise Data Access and Exchange
Direct access to the entimICE Data Repository while respecting entimICE DARE user permissions. Enables programmers to work with their preferred tools, data scientists to search and find data, and everyone to work with clinical data in entimICE using its virtual database driver.
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Program development
- Single Point of Truth
All data, programs and artifacts in one place. Secured and controlled. Accessible and traceable. Direct access for primary and secondary use. No uncontrolled copies.
- Access Control
Flexible role-based permission model, enabling super users to manage permissions for teams without involvement of IT administration. Granular control on any level from global areas down to single objects or even rows and columns in clinical data. Blinding of data is fully supported
- Workflow and Lifecycle Management
Configurable workflows for all objects over all lifecycle stages including simple review processes, double programming, validation forms, all combined with discussion forums for the users involved.
- Notifications
Relevant notifications for pending tasks, finished jobs or subscribed system notifications. They can be directly in the system guiding users to the point of action or delivered to your email inbox.
- Enterprise Search
Granular indexes on all data and metadata in the repository, constantly updated with the most recent changes, allow for powerful searches for information and data throughout the repository. Search definitions and search results are usable individually, can be shared with others, or can be used to trigger automated processes.
- Enterprise Data Access and Exchange
Direct access to the entimICE Data Repository while respecting entimICE DARE user permissions. Enables programmers to work with their preferred tools, data scientists to search and find data, and everyone to work with clinical data in entimICE using its virtual database driver.
Your benefits
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High security of your data and metadata
With entimICE DARE you find all data, metadata and tools in one secure place. Role- and group-based permissions are controlled down to the record level.
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Transparency and process compliance
With entimICE DARE, you can be sure to smoothly fulfill regulatory requirements, including FDA 21 CFR Part 11 and ICH GxP. Audit and status reports are just one click away. The solution natively supports the latest clinical standards including all published CDISC standards.
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Informed decision making
A comprehensive view of multiple data sources allows crucial go/no decisions to be taken earlier in the R&D process.
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High-performing analytical experience
Enterprise Data Access ensures entimICE DARE to be the clinical data hub in your organization, providing clinical data for analysis or processing to any downstream processes or applications.
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Reduced administrative effort
Super Users assign access rights and tasks to group members, no need to involve IT or system administrator.
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Speed up the development cycle
Spend less time searching for and aggregating data for analysis.
entimICE DARE components
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Metadata Repository (MDR)
The entimICE DARE Metadata Repository provides a model-independent standards and metadata repository, handling various types of clinical metadata throughout all stages of the drug development cycle.
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Clinical Data Repository (CDR)
The entimICE DARE Clinical Data Repository provides a safe place to store, manage and share clinical data in various formats and from multiple sources. An optional Mapping Generator helps with data transformation.
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Statistical Computing Environment (SCE)
The entimICE DARE Statistical Computing Environment is a powerful integrated framework for program development and execution with access to data flows from heterogeneous sources.
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Check tools
Integrated checkers ensure early issue detention and comprehensive reports can be used an effective communication tool for analysis and issue resolution.
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Submission tools
A dedicated generator guides users to create the define.xml for SDTM and ADaM with just a few mouse clicks.
Implementation
entimICE DARE is installed in the cloud or on premises.
The default configuration can be up and running within a short time at full power. In the course of optional configuration sprints, the system can be fine-tuned to reflect customer specific workflows, hierarchies and SOPs in detail. Additional modules can be licensed on demand and are simple to activate in the configuration.
entimo provides comprehensive support for all project phases including integration of external applications.
DARE add ons
entimICE Indexing Server (IX)
entimICE IX is a flexible and powerful search engine for entimICE, providing answers to various queries and questions in real-time. entimICE IX provides access to controlled queries against data, metadata, objects, keywords and text, across large repositories - similar to Google search.
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Fast access to any clinical data or metadata.
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Unified access to both entimICE data and external repositories/databases
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Fast access to any Frictionless clinical trial analysis with fewer manual steps.data or metadata.
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Easy querying, reducing effort for users.
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Real-time information delivery for immediate use
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More efficient overall clinical trial analysis process
entimICE Enterprise Data Access (EDA)
entimICE EDA provides easy, secure and high-performing access to all clinical data and metadata in entimICE, as well as access to external filesystems or databases. Source data are retrieved as virtual tables, which can be joined and combined by a full-featured SQL language. Retrieval of data can be executed by any tool of choice, while individual user access rights are always taken into account.
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Immediate availability of any data for smooth and efficient analysis of clinical studies.
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Supports flexible response to unexpected data access requests.
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Compatible with common analysis tools such as R Studio, Python, and Jupyter.
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Provides easy, secure, and high-performing access to clinical or related data.
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Connects seamlessly with common IT tools and data storage technologies.
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Grants simultaneous access to all data and metadata stored in entimICE.
Are you looking for a comprehensive solution for your RnD process?
If you think entimICE can speed up your clinical development process and want to find out more about it, our experts will be happy to discuss your project with you.
- Details
entimo moves up in environmental rating
entimo’s 2025 Climate Change rating from CDP (formerly the Carbon Disclosure Project) has improved significantly compared to 2024, and now stands at a B level. This marks meaningful progress in our environmental transparency and climate action efforts. A rating at this level recognizes verified, evidence-based climate action and shows that entimo has moved from awareness into meaningful implementation. This is also the highest score a company can achieve without public CDP disclosure, and it highlights not only our progress, but the strength of our internal governance and climate processes.
In 2025, CDP continued its global mission of encouraging organizations to disclose how their business activities affect the environment covering climate change, forests, and water security issues. CDP scoring helps investors, clients, and partners understand a company’s environmental performance and governance against internationally recognized criteria.
What does a “B” rating mean?
CDP’s scoring methodology evaluates companies across four key stages of environmental maturity:
- Disclosure (D/D-) – basic reporting of environmental data
- Awareness (C/C-) – understanding of environmental risks and impacts
- Management (B/B-) – implementation of strategies and processes to manage impacts
- Leadership (A/A-) – best-in-class climate strategies and verified action
A “B” rating means that Entimo is now firmly in the Management category. Companies in this band demonstrate structured environmental management practices and evidence of progress toward measurable goals.
This rating is the highest category currently available to organizations that do not make their CDP disclosures fully public, a context that helps clarify where Entimo sits relative to global reporting standards.
But this score is much more than a letter.
It represents months of effort, collaboration, and shared commitment across the entire organization. Teams came together — across Operations, Corporate Services, Quality, Data, and beyond — to strengthen our climate governance, improve data transparency, refine internal reporting workflows, and establish new processes that directly contributed to this achievement.
What does the rating mean for entimo?
For entimo, this improved score:
- Places us above the global average for privately disclosing SMEs, demonstrating that entimo is performing at a high sustainability maturity level.
- Strengthens our credibility with pharmaceutical and life science partners who evaluate environmental governance as part of their supplier and vendor assessments.
- Enhances our position in procurement and due diligence processes, where CDP scores are increasingly used as proof of climate action.
- Builds trust among investors and stakeholders, showing that entimo manages climate-related risks responsibly and transparently.
- Reinforces what we are like as an employer, showing current and future colleagues that we are committed to positive, measurable environmental impact.
This achievement reflects where we stand today — and motivates where we go next.
Looking Ahead
While we’re proud of the improvement, a B rating also highlights opportunities for continued growth. Our goals include:
- Deepening engagement across environmental themes beyond climate.
- Further embedding sustainability into strategic decision-making.
- Exploring best practices that could position us for future upward movement in CDP scoring.
We remain committed to transparent environmental reporting and action not just for compliance, but because responsible environmental stewardship is foundational to long-term resilience and value creation.
- Details
- Written by: Entimo AG
Inside the 33rd BVMA Symposium:
Reflections from entimo’s CEO Marc Jantke
The 33rd BVMA Symposium in Munich brought together an extraordinary cross-section of Germany’s clinical research landscape including industry leaders, regulatory agencies, CROs, sponsors, NGOs, and government representatives. For entimo’s CEO, Marc Jantke, it was his first time stepping into what some attendees call a “class reunion.” As it turned out, the nickname was more accurate than he expected.
BVMA Symposium Recap
Marc describes the opening get-together as “a fantastic opportunity to connect with others and talk about industry topics and everything beyond,” an atmosphere that set the tone for the entire event. What followed on the next day was a series of carefully curated presentations and discussions. They offered both high-level regulatory overviews and practical insights from experts navigating the daily realities of clinical research in Germany and across Europe.
The symposium exceeded every expectation, both in content and in the quality of professional engagement.
Key Insights: Safety Reporting & European Regulatory Gaps
One presentation in particular stood out: the talk by Dr. Jürgen Kübler (QSciCon), also the head of entimo’s supervisory board. Dr. Kübler presented perspectives on the evolving requirements for safety reporting in clinical trials, highlighting:
- How the FDA has provided guidance while still leaving important questions unresolved
- How the EMA has yet to meaningfully address the topic
Marc noted this contrast as a reminder of how unevenly global regulatory bodies handle fast-shifting safety expectations, a challenge that directly affects sponsors, CROs, and software providers.
The afternoon moved into a dynamic roundtable with NGOs, industry groups, and government representatives, openly discussing Germany’s competitiveness as a clinical trial location. Topics included:
- Operational bottlenecks
- The need for clearer regulatory frameworks
- Ideas for improving efficiency and global positioning
These conversations pointed toward a shared ambition of reinforcing Germany’s role as a major hub for clinical research in Europe.
Marc, who regularly attends conferences across the EU and internationally, sees the BVMA Symposium as unlike any other. He highlights two defining aspects:
- A German focus without losing the global perspective
Discussions are highly tailored to the regulatory and operational realities of clinical trials conducted in Germany, a detail that is often overlooked at broader European or global conferences.
- Constructive dialogue across all stakeholder levels
It’s rare to find industry leaders, regulatory authorities, and government institutions engaging so openly and constructively. This blend makes BVMA a uniquely productive meeting ground where real issues can be aired and real solutions imagined.
Looking Ahead to 2026 and Final Thoughts
After such a strong first experience, Marc has no doubts about returning. He says, “I definitely intend to revisit the BVMA Symposium next year and foster my connections to become a part of the class reunion eventually.”
The 33rd BVMA Symposium was a window into German clinical research. With open dialogue, deep technical insights, and a rare spirit of collaboration, it reinforced what many in the field already know: Germany’s clinical research ecosystem is evolving quickly, and events like BVMA are essential for ensuring that evolution is informed, collaborative, and forward-looking.
Learn More
To explore the BVMA’s mission, activities, and upcoming events, you can visit their official website:
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- Written by: Entimo AG
Your tech ally for fast and compliant clinical research
About entimo
Entimo AG is a German life sciences informatics company that provides software solutions and services to biopharmaceutical and contract research organizations. Our software and services address regulatory requirements in clinical research and development.
We use state-of-the art technical approaches to meet current challenges, and adaptable methods that anticipate future needs in the biopharmaceutical and life sciences sector. We provide our customers top-quality engineering, powerful tools, and the best possible customer support.
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2002
Continuously growing since
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Berlin, Germany
Headquartered in
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50+ PHUSE presentations
Delivered at key events
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17 nationalities
Colleagues from
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Net zero since 2024
For scope 1 and 2 emissions
Our values
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Innovation without disruption
We help to streamline and optimize systems and processes, enhancing them continuously and building lasting value. At the same time, our commitment to quality and strict standards ensures that every line of code, every feature, and every user interface reflects precision and performance. Our ongoing innovation is sustaining and empowers our customers to advance clinical data science with confidence.
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Commitment to success
Clinical breakthroughs depend on tools that work without causing a burden. We understand the weight of the trust our customers place in us, and the responsibility that comes with supporting life-changing research. Our promise is simple and we keep it: We deliver solutions that are reliable, thoughtfully designed, and easy to integrate. So that you can focus on data science and successful submissions. -
Constant collaboration
Software does not solve problems on its own—people and experience do. We collaborate closely with our customers and the clinical community—listening carefully to build tools that help clinical data scientists in making a real impact to address patients’ needs. Our long-lasting relationships with customers are grounded in empathy, decades of experience and shared purpose.
Our milestones
Our leadership
Marc Jantke
Managing Director | CEO | with entimo since 2004
Our teams value the flexible and friendly work environment with options to grow their talents. This enables us to drive meaningful innovations for our products and services without ever compromising our highest standards regarding quality and compliance.
Marc Jantke
Managing Director | CEO | with entimo since 2004
Marc Jantke
Managing Director | CEO | with entimo since 2004
Our teams value the flexible and friendly work environment with options to grow their talents. This enables us to drive meaningful innovations for our products and services without ever compromising our highest standards regarding quality and compliance.
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Marc oversees product development, marketing, sales and partners at entimo. -
Before joining the Board in 2020, Marc managed the regulatory-compliant product development and led the agile transformation at entimo.
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Marc has a Master’s degree in Medical Informatics from the University of Heidelberg.
Sven Prasse
Managing Director | COO | with entimo since 2002
At entimo, we combine an agile mindset with expert software development and clinical R&D experience. We have been trusted partners for decades, building and maintaining regulatory-compliant solutions for today and the future.
Sven Prasse
Managing Director | COO | with entimo since 2002
Sven Prasse
Managing Director | COO | with entimo since 2002
At entimo, we combine an agile mindset with expert software development and clinical R&D experience. We have been trusted partners for decades, building and maintaining regulatory compliant solutions for today and the future.
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Sven oversees operations, professional services, finance and administration at entimo.
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Before becoming Managing Director in 2020, Sven managed various enterprise service projects in GxP-regulated environments for pharmaceutical research and development.
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Sven has a Master’s degree in Computer Science from the Technical University of Berlin.
- Details
Fasttrack your submission
entimICE FastTrack Statistical Computing Environment significantly increases the efficiency of the clinical data science processes, managing constantly growing study pipelines, resource bottlenecks, and ever-increasing regulatory requirements. entimICE FastTrack is ready today for data from decentralized clinical trials and various sources, and fully supports real-time analysis and reporting along with the use of AI/ML.
Solutions for every customer
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Accelerated Time to Market
entimICE FastTrack significantly increases the efficiency of clinical data science processes, managing growing study pipelines and resource bottlenecks t
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Accelerated Time to Market
entimICE FastTrack significantly increases the efficiency of clinical data science processes, managing growing study pipelines and resource bottlenecks t
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Accelerated Time to Market
entimICE FastTrack significantly increases the efficiency of clinical data science processes, managing growing study pipelines and resource bottlenecks t
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Accelerated Time to Market
entimICE FastTrack significantly increases the efficiency of clinical data science processes, managing growing study pipelines and resource bottlenecks t
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Accelerated Time to Market
entimICE FastTrack significantly increases the efficiency of clinical data science processes, managing growing study pipelines and resource bottlenecks t
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Accelerated Time to Market
entimICE FastTrack significantly increases the efficiency of clinical data science processes, managing growing study pipelines and resource bottlenecks t
Solutions for every customer
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Statistical Computing Environment
- Language-agnostic development with direct access to native SAS, Posit (RStudio), and Python environments - enabling users to code in their preferred interface without leaving the platform.
- Automatic traceability of program executions and clinical data flow, enabling the viewing of 'bigger picture' throgh interactive graphs and automated re-runs for outdated outputs.
- Inbuild robust workflows from development to production facilitating lifecycle management and validation, ensuring quality control, documentation and signature driven approval.
- Automation tools, including program run sequences and job manager which eliminate repetitive tasks. Our open API enables integration and automation across external systems and enterprise workflows.
- Configurable non-blocking interface to provide optimal support for individual working styles. Flexible dashboards guide users to the repository objects.
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Universal Data Access
- Access any data source including clinical, legacy, biomarker, lab, device and real-world data to utilise your study data quickly and easily.
- Open REST APIs enable connectivity with upstream data sources for controlled access to data and metadata in entimICE FastTrack.
- Secure role based access to data to ensure data security and compliance.
- Ingest structured and unstructured data in real time with automated quality checks.
- Manage data standards centrally and apply them at global or study levels.
- Intuitive search and navigation features, so that users can quickly find artefacts of interest such as programs, datasets, or output files.
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Clinical Data Science Ecosystem
- entimICE FastTrack is a cloud native, integrated clinical platform that combines the power of a Statistical Computing Environment, open source tools and out-of-the box workflows to stream analysis and reporting activities.
- Based on microservices with significantly shorter test and validation cycles, enabling scalability for business growth.
- Standardised and validated REST APIs allow easy integration of any third party commercial or open-source tool with entimICE FastTrack.
- Enhanced study specific metadata and terminology support to enhance data standardisation, validation and review processes.
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Enterprise Collaboration
- Study Progress dashboards and reports provide a complete overview of activities in all ongoing studies and enables active task and deliverable management.
- Built-in workflows ensure the process management of all objects covering lifecycle management and QC framework for submission review.
- Issue tracking at all levels with automatic notifications with full audit trail enable faster query resolution, eliminating the need of traditional and tedious spreadsheet based tracking.
- Collaborate with study teams to resolve programming and source data discrepancies and medical writers to streamline clinical data review.
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Security and Compliance
- Automatic end-to-end traceability and effortless compliance with regulatory requirements, including FDA 21 CFR Part 11, EU Annex 11 and ICH GxP.
- Flexible search and reporting engine so you can easily find relevant information from version control, audit trails, object history and execution traces.
- Flexible role based permission model that enables team to manage access control for internal users and partners with confidence.
- Reliable and reportable electronics signatures to validate relevant workflows.
- Comprehensive, tamper-proof audit trails that log every action, change, and decision - ensuring full accountability, transparency, and inspection readiness.
Solutions for every customer
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Efficient and GxP compliant clinical trial analysis and reporting
Statistical analysis
ectrum. In addition toxicokinetic studies for non-individualized (rodents) and individualized animals are supported. PhaLIMS includes a set of integrated administration, management, planning, proces
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Efficient and GxP compliant clinical trial analysis and reporting
Statistical analysis
ectrum. In addition toxicokinetic studies for non-individualized (rodents) and individualized animals are supported. PhaLIMS includes a set of integrated administration, management, planning, proces
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Efficient and GxP compliant clinical trial analysis and reporting
Statistical analysis
ectrum. In addition toxicokinetic studies for non-individualized (rodents) and individualized animals are supported. PhaLIMS includes a set of integrated administration, management, planning, proces
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Efficient and GxP compliant clinical trial analysis and reporting
Statistical analysis
ectrum. In addition toxicokinetic studies for non-individualized (rodents) and individualized animals are supported. PhaLIMS includes a set of integrated administration, management, planning, proces
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Efficient and GxP compliant clinical trial analysis and reporting
Statistical analysis
ectrum. In addition toxicokinetic studies for non-individualized (rodents) and individualized animals are supported. PhaLIMS includes a set of integrated administration, management, planning, proces
Got a project in mind?
- Details
Your profile
You are working with a pharma or biotech company with an active phase II/phase III clinical trial pipeline. Your clinical data science ecosystem is overly complex or outdated, in the worst case both. Your daily business processes are disconnected and inefficient and your clinical trial teams blocked by the inability to use the best tools for the tasks at hand.
Your challenge
Our solution
entimICE FastTrack offers an open-platform clinical data repository and statistical computing environment.
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- It enables template-based study setups in just minutes and supports data ingestion pipelines from systems such as CTMS and EDC, as well as from data providers including CROs and laboratories.
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- Built-in study tracking and performance metrics keep managers informed and in control, driving faster submissions.
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- Automated checks and workflows streamline repetitive tasks, significantly accelerating the submission process.
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- Regulatory compliance is maintained automatically, ensuring consistent and reliable on-time submissions without the need for manual effort.
More use cases
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Collaboration with CROs
Outsourcing
How to keep end-to-end oversight and compliance in fully outsourced SMB and generics programs?
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Multi-sponsor management for CROs
Sponsor handling
How does entimICE FastTrack manage the complexities of sponsor requirements in CRO operations?
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Enabling open source for regulatory activities
Open source technology
Is it realistic to expect open-source solutions to fully satisfy stringent regulatory compliance requirements?
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Enbling open source for non-regulatory activities
Open source technology
How can organizations effectively manage the often-chaotic transition from real-world data to structured clinical research?
Have a project in mind?
Discover how our solution can streamline your workflows and elevate your results—contact us today to learn how it works for your organization.
- Details
Your profile
You are working for a biotech or pharma company with an active Phase III clinical trial pipeline, or for a CRO providing biometrics services to sponsors. Your teams are engaged to make use of R in clinical trial reporting activities, in combination with SAS or as a replacement for SAS.
Your challenge
The use of open-source technologies such as R and Python in clinical R&D has been growing steadily for years, with R already successfully used in initial clinical trial submissions to the FDA. However, meeting GxP compliance requirements for these tools is challenging, as neither R nor Python natively provide the necessary controls or documentation to fulfill regulatory standards.
Our solution
entimICE FastTrack delivers a fully validated data science platform with GxP-compliant integrations for SAS, R, and Python, providing a robust foundation for using open-source tools in clinical trial analyses and regulatory submissions.
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- The platform seamlessly integrates with popular open-source IDEs such as RStudio and JupyterHub, as well as commercial solutions such as Posit Workbench.
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- The unified environment of entimICE FastTrack enables customers to manage R package and Python module validation within the same validated setup used for clinical trial programming.
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- With entimICE FastTrack, regulatory compliance is ensured across all programming languages—SAS, R, or Python.
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- This approach makes the creation of deliverables and execution of program runs both simple and compliant.
More use cases
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GxP-compliant clinical trial analysis & reporting
Submissions
What barriers remain to accelerating fully GxP-compliant clinical trial analysis and submissions?
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Collaboration with CROs
Outsourcing
How to keep end-to-end oversight and compliance in fully outsourced SMB and generics programs?
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Multi-sponsor management for CROs
Sponsor handling
How does entimICE FastTrack manage the complexities of sponsor requirements in CRO operations?
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Enbling open source for non-regulatory activities
Open source technology
How can organizations effectively manage the often-chaotic transition from real-world data to structured clinical research?
Have a project in mind?
Discover how our solution can streamline your workflows and elevate your results—contact us today to learn how it works for your organization.
- Details
Your profile
You are working with a pharma or biotech company with active real-world evidence projects. Your company has an established Phase II/Phase III clinical trial pipeline, and you are looking to smooth the transition between real-world research and clinical trial research.
Your challenge
Open-source technologies such as R and Python have long been used in real-world research. As their adoption in clinical research and development continues to grow, there is an increasing need to bridge the gap between real-world evidence and clinical trial research. The goal is to bring these domains closer together, enabling insights from real-world data to be more effectively leveraged within clinical trial settings
Our solution
entimICE FastTrack offers a validated data science platform with flexible hierarchies, workflows, and permission structures, enabling both regulatory and non-regulatory activities to be supported within the same environment.
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- Real-world research projects can be carried out using R and Python with the flexibility to leverage a wide range of packages and modules, and with minimal constraints on workflows and traceability.
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- When needed, work can transition seamlessly to more controlled areas within the same platform, where clinical trial analysis for regulatory submissions is performed using validated and standardized execution environments for SAS, R, and Python.
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- In these regulated areas, workflows and traceability are tightly managed, guiding users efficiently through each step of the submission process.
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- entimICE FastTrack simplifies and speeds all of these processes in research projects.
More use cases
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GxP-compliant clinical trial analysis & reporting
Submissions
What barriers remain to accelerating fully GxP-compliant clinical trial analysis and submissions?
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Collaboration with CROs
Outsourcing
How to keep end-to-end oversight and compliance in fully outsourced SMB and generics programs?
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Multi-sponsor management for CROs
Sponsor handling
How does entimICE FastTrack manage the complexities of sponsor requirements in CRO operations?
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Enabling open source for regulatory activities
Open source technology
Is it realistic to expect open-source solutions to fully satisfy stringent regulatory compliance requirements?
Have a project in mind?
Discover how our solution can streamline your workflows and elevate your results—contact us today to learn how it works for your organization.
- Details
Your profile
Data management and biometrics teams involved in clinical trials across multiple sponsors often work with a mix of systems—some provided by the sponsor, others based on their own internal setups. Each sponsor typically enforces their own SOPs, requiring your CRO to adapt its processes and tools to meet different expectations. This requires a high level of flexibility from CRO teams to ensure compliance and efficient collaboration.
Your challenge
You are working for a CRO providing data management and statistical programming services to your clients. Your teams are working for various sponsors according to changing SOPs, sometimes in your own systems, sometimes in the client’s systems.
Our solution
entimICE FastTrack offers flexible hierarchies and workflows that enable CROs to efficiently manage clinical trial services for multiple sponsors within a single, unified data science platform.
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- entimICE FastTrack ensures complete data isolation and integrity for each sponsor, while also accommodating sponsor-specific processes within the same environment.
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- The platform supports parallel execution environments for SAS, R, and Python, meeting diverse technical requirements.
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- Additionally, data exchange with sponsors can be fully automated, streamlining collaboration and reducing manual effort.
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- entimICE FastTrack can improve processes within a CRO as well as collaboration with study sponsors.
More use cases
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GxP-compliant clinical trial analysis & reporting
Submissions
What barriers remain to accelerating fully GxP-compliant clinical trial analysis and submissions?
-
Collaboration with CROs
Outsourcing
How to keep end-to-end oversight and compliance in fully outsourced SMB and generics programs?
-
Enabling open source for regulatory activities
Open source technology
Is it realistic to expect open-source solutions to fully satisfy stringent regulatory compliance requirements?
-
Enbling open source for non-regulatory activities
Open source technology
How can organizations effectively manage the often-chaotic transition from real-world data to structured clinical research?
Have a project in mind?
Discover how our solution can streamline your workflows and elevate your results—contact us today to learn how it works for your organization.
- Details
Your profile
You are working for a small-to-midsized biopharma (SMB) or a biosimilars generics pharma company with a few clinical trials. Your company is outsourcing most activities to CROs, and your small biometrics team manages many deliveries from multiple different CROs simultaneously.
Your challenge
SMB biopharma and biosimilars generics pharma companies often fully outsource the management of clinical trials to CROs, typically working with a diverse range of partners. This creates a need for strong oversight and effective collaboration management. To prepare for regulatory submissions, sponsors must ensure all study deliverables from CROs are handled within a validated environment and apply their own quality control methods to verify these deliverables.
Our solution
entimICE FastTrack offers flexible hierarchies to accommodate a wide range of requirements and use cases. It provides two streamlined options for data exchange between sponsors and multiple CROs.
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- In the first option, CROs upload and retrieve data via a secure dedicated staging area, from which data can be automatically brought into entimICE FastTrack and trigger initial workflows.
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- In the second option, CROs work directly within the platform, delivering data exactly where the sponsor needs it for further processing.
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- A clear separation of permissions ensures that each CRO has access only to their specific data delivery points, thus maintaining security while enabling efficient collaboration.
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- Additionally, entimICE FastTrack supports customizable workflows, allowing sponsors to define the appropriate level of quality control based on the type and source of data received from each CRO.
More use cases
-
GxP-compliant clinical trial analysis & reporting
Submissions
What barriers remain to accelerating fully GxP-compliant clinical trial analysis and submissions?
-
Multi-sponsor management for CROs
Sponsor handling
How does entimICE FastTrack manage the complexities of sponsor requirements in CRO operations?
-
Enabling open source for regulatory activities
Open source technology
Is it realistic to expect open-source solutions to fully satisfy stringent regulatory compliance requirements?
-
Enbling open source for non-regulatory activities
Open source technology
How can organizations effectively manage the often-chaotic transition from real-world data to structured clinical research?
Have a project in mind?
Discover how our solution can streamline your workflows and elevate your results—contact us today to learn how it works for your organization.
- Details
entimICE® FastTrack
Fast-track your submission
The first cloud-native compliant SCE for clinical research
entimICE FastTrack statistical computing environment significantly increases the efficiency of clinical data science processes, managing constantly growing study pipelines, resource bottlenecks, and ever-increasing regulatory requirements.
entimICE FastTrack is ready today for data from decentralized clinical trials and various sources, and fully supports real-time analysis and reporting along with the use of AI/ML.
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284
distinct user requirements fulfilled
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6 – 9
months average time to go-live
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1000+
entimICE users worlwide
Your benefits
A meaningful difference in your clinical operations
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Accelerated time to market
entimICE FastTrack significantly increases the efficiency of clinical data science processes, managing growing study pipelines and avoiding resource bottlenecks.
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Risk reduction and compliance
Built by domain experts for today’s clinical challenges, the enterprise-grade platform ensures reliable processing, traceable outcomes, and effortless compliance.
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Scalability for growth
Designed for sponsors, CROs, and biotechs of all sizes, the platform adapts to your needs and scales with your portfolio, managing constantly growing study pipelines and evolving operational demands.
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Future-proof operations
entimICE FastTrack is ready today for data from decentralized clinical trials and various sources, fully supporting real-time analysis, reporting, and the use of AI/ML—ensuring your organization stays ahead of evolving trial models and technology trends.
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Operational efficiency
With an intuitive, language-agnostic environment, entimICE FastTrack streamlines code development, automates data transformation, and accelerates deliverable creation through integrated, end-to-end workflows.
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Cost savings
Centralized governance and actionable workflows reduce reliance on manual, fragmented processes thus improving visibility, freeing expert resources, and lowering operational and validation costs.
entimICE FastTrack in detail
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Statistical Computing Environment
- Language-agnostic and flexible UI
Work natively in SAS, Posit (RStudio), or Python through a configurable, non-blocking UI with flexible dashboards tailored to individual workflows. - Traceable
Automatic traceability of program executions and clinical data flow, enabling the viewing of the “bigger picture” through interactive graphs and automated re-runs for outdated outputs. - Quality control
Built-in robust workflows from development to production facilitate lifecycle management and validation, ensuring quality control, documentation, and signature-driven approval. - Automation
Automation tools, including program run sequences and a job manager, eliminate repetitive tasks. The open API enables integration and automation across external systems and enterprise workflows.
- Language-agnostic and flexible UI
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Universal Data Access
- Any data source
Access any clinical, legacy, or real-world data and quickly find relevant artifacts—including programs, datasets, and outputs—through intuitive search and navigation. - Connect upstream
Open REST APIs enable connectivity with upstream data sources for controlled access to data and metadata in entimICE FastTrack. - Ensure security
Secure, role-based access to data ensures data security and compliance. - Omnivorous
Ingest structured and unstructured data in real time with automated quality checks. - Granular standards
Manage data standards centrally and apply them at global or study levels.
- Any data source
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Clinical Data Science Ecosystem
- Integrated clinical platform
entimICE FastTrack is a cloud-native, integrated clinical platform that combines the power of a Statistical Computing Environment, open-source tools and out-of-the box workflows to stream analysis and reporting activities. - Microservices architecture
Based on microservices with significantly shorter test and validation cycles, enabling scalability for business growth. - Easy integration
Standardized and validated REST APIs allow easy integration of any third-party commercial or open-source tool with entimICE FastTrack. - Metadata support
Enhanced study-specific metadata and terminology support improve data standardization, validation and review processes.
- Integrated clinical platform
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Enterprise Collaboration
- Cloud Technology
entimICE FastTrack is a cloud-native, next-generation Statistical Computing Environment based on microservices, enabling scalability for business growth. - Easy overviews
Study Progress dashboards and reports provide a complete overview of activities in all ongoing studies and enables active task and deliverable management. - Managing processes
Built-in workflows ensure the process management of all objects covering lifecycle management and QC framework for submission review. - Modern tracking
Issue tracking at all levels with automatic notifications with full audit trail enable faster query resolution, eliminating the need for spreadsheet-based tracking. - Team collaboration
Collaborate with study teams to resolve programming and source data discrepancies, and with medical writers to streamline clinical data review.
- Cloud Technology
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Security and Compliance
- Meet key standards
Automatic end-to-end traceability and effortless compliance with regulatory requirements, including FDA 21 CFR Part 11, EU Annex 11 and ICH GxP. - Find what you need
Flexible search and reporting engine so you can easily find relevant information from version control, audit trails, object history and execution traces. - Assign permissions
Flexible role based permission model that enables team to manage access control for internal users and partners with confidence. - Sign and audit workflows
Electronic signatures and tamper-proof audit trails log every action and decision, ensuring full accountability, transparency, and inspection readiness.
- Meet key standards
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Download factsheet
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Request a demo
Use cases
-
GxP-compliant clinical trial analysis & reporting
Submissions
What barriers remain to accelerating fully GxP-compliant clinical trial analysis and submissions?
-
Collaboration with CROs
Outsourcing
How to keep end-to-end oversight and compliance in fully outsourced SMB and generics programs?
-
Multi-sponsor management for CROs
Sponsor handling
How does entimICE FastTrack manage the complexities of sponsor requirements in CRO operations?
-
Enabling open source for regulatory activities
Open source technology
Is it realistic to expect open-source solutions to fully satisfy stringent regulatory compliance requirements?
-
Enbling open source for non-regulatory activities
Open source technology
How can organizations effectively manage the often-chaotic transition from real-world data to structured clinical research?
FAQs
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What is entimICE FastTrack, and how is it different from other statistical computing environments (SCEs)?
entimICE FastTrack is a cloud-ready statistical computing environment purpose-built for clinical development. Unlike traditional SCEs that focus solely on code execution and audit trails, entimICE FastTrack offers a modular platform for programming, data integration, version control, automation, and compliance—all in a single, traceable environment. It supports multi-language workflows (R, SAS, Python) and enables end-to-end visibility across study programming activities, making it fit for future and GxP-compliant by design.
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How does entimICE FastTrack support traceability and regulatory compliance for submission-ready studies?
entimICE FastTrack offers built-in traceability through audit trails, role-based access controls, automatic metadata capture, and seamless versioning of datasets, code, outputs, and specifications. It enables easy generation and validation of submission packages (e.g., SDTM, ADaM, define.xml, aCRF, SDRG) and integrates with tools like Pinnacle 21. Compliance with 21 CFR Part 11 and other regulatory guidelines is maintained through secure infrastructure, activity logs, and electronic signatures where required.
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Can FastTrack integrate with other existing clinical trial systems and data sources?
Yes. entimICE FastTrack is built with interoperability in mind. It supports API-based integrations with major EDC platforms, lab systems, real-world data sources, and metadata repositories. Our ingestion framework enables you to centralize diverse data types—EDC, non-EDC, lab, biomarkers, and RWD—into a unified, accessible layer for downstream analysis.
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Can I assign tasks and monitor study progress within entimICE FastTrack?
Yes. entimICE FastTrack enables robust study-level tracking by organizing deliverables, milestones, and timelines across clinical projects. Built-in interactive features allow teams to monitor execution status, review versioned outputs, and maintain visibility into submission readiness. Through collaborative workspaces, user activity logs, and status indicators, teams stay aligned and accountable throughout the study lifecycle.
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What infrastructure options are available, and how secure is the platform?
entimICE FastTrack can be deployed in private cloud (AWS, Azure), or on-premises environments, depending on your IT policies. Security is a top priority—the platform includes encryption in transit, strict access controls, regular penetration testing, and compliance with global standards such as ISO/IEC 27001. Role-based permissions ensure data is accessed only by authorized users.
Have a project in mind?
Discover how our solution can streamline your workflows and elevate your results—contact us today to learn how it works for your organization.
- Details
German precision
Global trust
Faster submissions
Contact
Entimo is a pioneer in life sciences information technology, built on a foundation of precision, reliability, and quality—hallmarks of the “Made in Germany” standard. With more than 20 years of experience, we deliver future-ready software and expert services that simplify complex clinical research, enabling biopharma and CROs to manage data confidently, accelerate processes, and focus on advancing science with integrity and trust.
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650+years of professional business expertise
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145successful implementations
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10+years average customer relationship
Our business
Products
entimo empowers sponsors, biotechs, and biometrics service providers of all sizes with software and services that simplify the complexity of clinical data workflows. Our regulatory-grade Statistical Computing Environment, entimICE FastTrack, enables teams to take in, transform, analyze, and submit clinical trial data with clarity, speed, and full compliance. Whether you're a global pharmaceutical company, a mid-sized biotech, or a CRO managing multi-sponsor studies, entimICE FastTrack adapts to your needs—fit-for-purpose, language-agnostic, and seamlessly integrated with industry-standard tools.
Global services
entimo assists pharmaceutical and biotech organizations with proven enterprise-grade software and domain-specific consulting expertise. Our expertise in statistical programming, technology services, R programming services, and consulting on businesses and processes has given clients advantages in how they approach clinical trials and regulatory submissions.
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Statistical programming
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R Shiny and package validation
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Custom technology and software development
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Business and process consulting
Explore entimo’s service portfolio
Explore entimo services
Our foundations
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Innovation
We lead with innovation that’s grounded in compliance. From the first GxP-compliant SCE to cloud adoption and meaningful AI integration, we bring progress where it truly matters. Our open, future-ready platform respects existing systems while empowering researchers with the freedom to use tools and languages they trust.
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Experience
With more than 20 years of expertise in life sciences informatics, we understand the complexity of clinical research like few others. Our solutions are shaped by real-world use across global sponsors and CROs—designed, delivered, and supported by experts who’ve seen it all and know what works.
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Trust
Data, processes, procedures, partnerships—they all lead back to trust. Patients trust our sector to help improve their health. Every step toward new medications and new treatments depends on trust. For more than 20 years, entimo has kept our partners' trust and helped them meet regulatory standards: the place where trust meets proof.
Solutions for every company
Case studies
Our platform is the choice of companies worldwide to streamline clinical trial data analysis and reporting. See how Entimo helped organizations to deliver better outcomes, faster and cost effectively.
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Speeding up clinical trial analysis and reporting
Compliance
Accelerating the timeline from database lock to submission is critically important for sponsors. However, in many cases, systems, processes, and people are not well integrated, resulting in disruptions and delays.
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Making a complex web of partners more manageable
Outsourcing
Some researching companies outsource their clinical trials to a diverse array of partners. Everything that will be submitted has to be validated and coordinated. entimo can lighten that burden.
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Juggling multiple sponsors means integrating systems
Sponsors
Data Management and Biometrics teams involved in clinical trials across multiple sponsors work with a mix of system. Each sponsor has their own SOPs, requiring your CRO to adapt its processes and tools to meet different expectations. entimo can help simplify.
Latest news
See all news
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entimo moves up in environmental rating
Company goals
entimo’s 2025 Climate Change rating from CDP (formerly the Carbon Disclosure Project) has improved significantly compared to 2024, and now stands at a B level. This marks meaningful progress in our environmental transparency and climate action efforts. A rating at this level recognizes verified, evidence-based climate action and shows that entimo has moved from awareness into meaningful implementation.
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Inside the 33rd BVMA Symposium
Events
The 33rd BVMA Symposium in Munich brought together an extraordinary cross-section of Germany’s clinical research landscape including industry leaders, regulatory agencies, CROs, sponsors, NGOs, and government representatives. For entimo’s CEO, Marc Jantke, it was his first time stepping into what some attendees call a “class reunion.” As it turned out, the nickname was more accurate than he expected.
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entimo Presents at PHUSE US Connect 2025
Events
In March, entimo representatives joined industry colleagues at PHUSE US Connect in Orlando, Florida to drive conversations around innovations in SCEs and clinical data standards. Three from entimo delivered presentations, while the company sponsored the conference’s poster session.
- Details
entimo Presents at PHUSE US Connect 2025
Jörn Bilow (l) and Marc Jantke welcome visitors to the entimo booth at the 2025 PHUSE US Connect.
In March, entimo representatives joined industry colleagues at PHUSE US Connect in Orlando, Florida to drive conversations around innovations in SCEs and clinical data standards. Three from entimo delivered presentations, while the company sponsored the conference’s poster session.
entimo CEO Marc Jantke talked about the potential use of AI to overcome the validation burden for open-source packages. The talk discussed how LLMs can be used alongside R tools to aid in a GAMP-compliant validation process.
Chen Li from Boehringer Ingelheim and entimo’s Ivo Marek showcased InnoRand, the R Shiny based Randomization app that Boehringer has been using. InnoRand is fully validated, allows easy-to-use setups and modifications of randomization lists and provides a GxP compliant audit trail.
Shivoy Pandita, entimo’s third presenter, gave a talk on how knowledge graphs and JSON can be used to create a future-proof ecosystem for developing, executing and utilizing CDISC standards to support AI-driven compliance.
We are taking back a lot of new insights, connections and innovations shared at the conference, we are looking forward to seeing you at the CDISC EU Interchange 2025 in Geneva and the PHUSE EU Connect 2025 in Hamburg.
All presentations and the associated papers are available on the PHUSE archive. You can find the links here.
If you would like to connect with the entimo team, please fill out the entimo contact form.
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- Written by: Entimo AG