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 Your clinical data science ecosystem is overly complex or outdated, in the worst case both.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?
-
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?
-
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
-
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?
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
-
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