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.

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:

1. 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.

2. 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:

https://www.bvma.de/en/

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.

The entimo team at the 2024 PHUSE EU Connect in Strasbourg, France:
Jens Wientges, Monika Böselt, Jörn Bilow and Sven Prasse (l to r)

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.

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.

This is the first step in having our efforts recognized internationally by a global group that monitors emission reduction goals in line with what the latest climate science says is needed to prevent the worst effects of climate change. The process will continue with commitments to these targets and evaluation of how well entimo meets them.

The SBTi is a collaboration between CDP, the United Nations Global Compact, World Resources Institute and the World Wide Fund for Nature. CDP was formerly known as Carbon Disclosure Project, and entimo began sharing sustainability information with them in 2023. By committing to SBTi targets, entimo joins with thousands of other companies around the world that are each striving to be part of the solutions to climate change.

entimo will continue to work towards greater sustainability in our operations and to cooperate with partners seeking the same goals.

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.

The entimo team at the 2024 PHUSE Computational Science Symposium in Silver Spring, Maryland: Shivoy Pandita (l) and Jörn Bilow (r)

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 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.

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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The entimo team at the 2024 PHUSE US Connect in Bethesda, Maryland: Ivo Marek, Jörn Bilow, Shivoy Pantida (l to r)

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.

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.

The entimo team at PHUSE EU Connect 2023: Sven Prasse, Dmitry Zakharov, Marc Jantke, Jörn Bilow and Shivoy Pandita (l to r)

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

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.

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.