The 2025 PHUSE EU Connect saw record-breaking participation, beating the previous year’s record at the conference held November 16 to 19 in Hamburg, Germany.
The 2025 PHUSE EU Connect saw record-breaking participation, beating the previous year’s record at the conference held November 16 to 19 in Hamburg, Germany. Entimo’s participation broke through as well, with nine colleagues present, two presentations and lanyard sponsorship so that every attendee saw entimo wherever they went at PHUSE.
Frank Stoinski and Alexander Lüders gave a presentation on Fairchive, a long-term GxP archive for clinical trial data. Shivoy Pandita spoke about the opportunities and challenges of integrating an AI chatbot within a statistical computing environment. In addition, entimo hosted an industry-based quiz event, which drew good participation and offered a good test of knowledge for our peers and cool prizes for the winners.
“We had many good talks and cross-industry exchanges during our four days in Hamburg,” said Marc Jantke, entimo CEO. “It was another perfectly organized PHUSE event.”
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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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The 2024 PHUSE EU Connect saw record-breaking participation, boasting the largest in-person attendance at Connect to date! Jörn Bilow and Shivoy Pandita gave a talk in the software demonstrations stream about the integration of entimo’s next generation SCE entimICE FastTrack with Posit tools such as Posit Workbench and Posit Connect, utilizing the system's Open API for running R Shiny applications, while maintaining full traceability and regulatory compliance. In addition to the presentation, entimo sponsored the poster session, a great forum to share new developments in clinical data science, and participated in the event as both an exhibitor and a presenter. Sven Prasse presented a poster “The jungle in the cloud” showcasing the many laws and regulations as a way to assure safe and compliant processing of clinical data with AI or on cloud-based infrastructure. It was great to see the energy and collaboration as our attendees explore innovative ideas and connect with the poster presenters.
A brief summary of the event can be read on the PHUSE blog, and all presentations will be available on the PHUSE archive shortly.
Choosing a secure, reliable, and trusted statistical computing environment (SCE) is crucial for analysing clinical trial data for regulatory submissions. Equally important is selecting an SCE that is future-ready—scalable, cloud-native, and open. entimICE FastTrack combines these strengths seamlessly. By enhancing open-source capabilities while maintaining compliance and accuracy, entimo partners with organizations to drive superior results in clinical data programming and analytics. If you would like to connect with the entimo team, please fill out the entimo contact form.
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The Science Based Targets initiative (SBTi), an international organization dedicated to fighting the climate crisis, has accepted the targets set by entimo for reducing our carbon emissions.
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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.
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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.
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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.
“We are proud to announce entimo's collaboration with Posit PBC as a trusted software partner. The Posit PBC products are an excellent addition to our portfolio, allowing entimICE users to be even more efficient in their daily work. Posit Workbench offers a powerful alternative to R Studio, for R and Python code development in clinical trials and for exploratory purposes. entimICE FastTrack tightly integrates with Posit Workbench and takes care of regulatory compliance, workflows and end-to-end tracing of all activities within FastTrack and Workbench. The optional usage of Posit Package Manager allows managing package versions and repositories beyond CRAN, enabling statisticians to spend more time on using packages rather than managing packages. The integration of entimICE FastTrack and Posit Connect brings R Shiny apps to the next level in data analysis and visualization, managing the deployment and access to apps and data according to company SOPs and compliance rules. Altogether, the symbiosis of entimICE FastTrack and the Posit PBC products is a big step to foster the use of open-source technologies in clinical trial analysis,” said Marc Jantke, CEO at entimo.
“We are excited to be working with entimo, uniting our expertise with their modern statistical computing environment entimICE FastTrack, which is being used at pharmaceutical and biotech companies of all sizes. Having collaborated for many years, this formal alliance is a natural progression of our relationship. It’s not just about enhancing our product offerings; it’s a commitment to pioneering the future of clinical data science together. We look forward to driving innovation and delivering exceptional value to our customers worldwide through this synergistic partnership. This partnership will help customers in pharma and biotech, who are ready to embrace open-source solutions in a fully compliant way, to increase their productivity and improve their clinical data analysis workflows,” said Andrea Tharp, Head of Global Channels at Posit PBC.
About Posit PBC
Posit PBC (previously R Studio) was founded in 2009 with the vision of creating high quality open-source software for data scientists. Posit PBC has grown exponentially and invests heavily in open-source development, education, and the community with the goal of serving knowledge creators 100 years from now. Posit PBC's mission is to create open-source software for data science, scientific research, and technical communication. In 2022, R Studio became Posit PBC and released Shiny for Python. Posit PBC provides commercial softwares: Posit Connect, Posit Workbench, and Posit Package Manager and supports more than just R. Over the past few years, Posit PBC has already been investing in other languages like reticulate (calling Python from R), Released the Positron IDE for language agnostic data science, Python features for the IDE, and support for Python and Julia within Quarto.
Visit Posit PBC on the web.
About Entimo
Entimo AG is a life sciences informatics company providing solutions and services to biopharmaceutical and contract research organizations, addressing regulatory requirements in clinical research and development. Entimo AG delivers innovative software solutions and professional services for clinical data and standards management, for statistical analysis and biometrics, and for successful submissions to regulatory authorities. Entimo AG has a track record of matching innovation with reliability since 2003 and serves clients around the globe. In 2021, Entimo AG released its flagship state-of-the-art statistical computing environment entimICE FastTrack on cloud, built on decades-long experience in the pharmaceutical industry, developing high-quality clinical solutions and providing professional services to the market.
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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.
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At the 2024 PHUSE US Connect, entimo team members gave two presentations to interested attendees. Jörn Bilow and Shivoy Pandita gave a talk in the software demonstrations stream about automation within entimICE FastTrack utilizing the system's Open API from R programs, while maintaining full traceability and regulatory compliance. Ivo Marek presented with Boehringer Ingelheim on innovative randomization algorithms currently developed by the Randomization Working Group showcased in an R Shiny app. In addition to the presentations, entimo sponsored the poster session, a great forum to share new developments in clinical data science, and participated in the event as exhibitor. PHUSE US Connect was held in North Bethesda, Maryland, February 25 to 28. All presentations will be available on the PHUSE archive, or via the entimo contact form.
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entimo is making substantial progress on the road towards sustainability, to ultimately live up to our green company color. In scope of the efforts in 2023, entimo has disclosed the corporate sustainability benchmark reports to a scoring platform and rating agency. Overall results show significant improvements in environmental and supply chain sustainability, leading to a superior score compared to last year. entimo is extremely proud to be rated in the top percentiles of the industry and will continue this journey towards sustainability in 2024.
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At PHUSE EU Connect 2023, held in Birmingham in November, three teams from entimo gave presentations to the clinical data science conference. Marc Jantke, entimo CEO, and Javeed Paray (Abbott) gave a talk titled, “Application Development: Go-live for a new SCE is not the end of a journey but just another spot along the way.” Shivoy Pandita and Suchitra Ramaswamy (Zifo) discussed the benefits of integrated data visualizations capabilities for statistical programmers, while Dmitry Zakharov presented on automation and orchestration.
“PHUSE Connect is the place to be for getting in touch with industry experts and decision makers” said Marc Jantke, entimo CEO. entimo sponsored the Poster Session, which was a place for participating organizations to present topics visually, and a great venue for informal networking. The entimo booth also gave visitors an opportunity to see our latest work and ask us questions directly.
All three presentations are available on the PHUSE archive, or via the entimo contact form.
- 3P to V – How People, Process and Product Generate Mutual Business Value: Review of an SCE Journey: Presentation Slides / Paper
- Real-Time Safety and Medical Review by Integrating Data Visualisations with an SCE: Presentation Slides / Paper
- Automation and Orchestration of Data Science Applications Using OpenAPI: Presentation Slides / Paper
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For the ninth time, entimo invited its entimICE customers to the annual User Group Meeting. The two-day agenda was filled with presentations, discussions, interactive workshops and an evening event. Two new clients, both users of the next generation data science platform entimICE FastTrack, participated for the first time along with customers who will continue to use entimICE DARE.
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entimo has released version 2.1 of its integrated SCE/CDR solution. entimICE FastTrack in its latest version now provides new advanced visualization capabilities to review dependencies from data capture to submission. Users benefit from the capability to identify potentially outdated results and update them easily by relevant program reruns. On a higher level, submission readiness and data fitness are reported in comprehensive dashboards for both single studies as well as across multiple studies. Thus, clinical data science receives a significant boost towards faster and successful submissions with these dependency and progress reports.
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New features and updates to entimICE FastTrack are available in the latest 2.0 release. Highlights include a GxP compliant audit trail, end-to-end dependency tracking and out-of-date object visualization. The system supports lifecycle and workflow management including electronic signatures, configurable validation forms, data compliance checks and comprehensive reporting of all these activities. Authentication is now supported via OIDC (cloud based ID providers) or LDAP (Active Directory) integration. For more information on how entimICE FastTrack can help your organization, please contact entimo using this form.
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