Evolution with Intent:

By Marc Jantke, CEO

Evolution in the life science industry, especially as a solution provider, can no longer be just an advertising slogan, it is an operational necessity. The complexity of clinical trial designs is increasing rapidly, as are data volumes with biomarker and real-world data being utilized in scope of clinical trials. At the same time, regulatory authorities are striving towards more transparency and agility in the submission process while supporting an increasing amount of data formats and technologies for submission artifacts. Our rebranding and website redesign at entimo is not just about a new look, it is an expression of how we are shaping our evolution.

Why we evolved

For decades, clinical data science has relied on fragmented tools and processes, siloed information and knowledge. While this approach has been successful in the past, it is not enough to address today’s challenges:

• Adaptive and complex trial designs
• Hybrid data sources including EDC, non-EDC, biomarkers, and real-world data
• Tighter regulatory requirements around traceability and reproducibility
• Growing pressure to do more, faster with fewer resources

Study teams today need more than just tools. They need reliably working and performing platforms where governance and traceability are naturally embedded, and not kept together by SOPs and manual efforts. Collaboration within teams and across the organization must be designed as automations into daily workflows.

Our understanding of the evolution of industry demands and needs is driving our own evolution at entimo. We know that technology and infrastructure are playing a more important role and must equally contribute as solutions to address growing submission complexity within shorter timelines.

entimICE FastTrack is our answer to these requirements. Governance, traceability, compliance and the transparent flow of data and information are essential pieces of the underlying system design. Scalability, flexibility and accessibility are the driving forces to empower clinical data scientists to full focus and commit on relevant tasks.

Industry trends we see accelerating

In our collaboration with customers, partners and industry peers, we see the following trends becoming impossible to ignore:

• Increasing trial complexity driven by precision medicine and adaptive trial designs
• Increasing use of real-world data, as well as clinical data
• Increasing emphasis from regulatory authorities on data lineage, validation, and reproducibility for any technology used
• Increasing needs to effectively incorporate AI and ML, while avoiding the risk of compromising trust

All of these trends suggest that the answer to these challenges will not be found in individual tools or techological breakthroughs but rather in platforms that are able to orchestrate all these complexities without encumbering teams and organizations.

Our perspective going forward

At entimo we are not trying to be everything for everyone. We focus on providing solutions that allow clinical data science teams to operate with confidence and speed. Now and in the future.

Our refreshed brand identity and website are just an external expression of this committment to excellence and evolution. This represents our identity, how we see technology should play a role in getting safe medicines to patients faster, and our contribution with solutions and expertise.

This evolution at entimo is driven by intention. As such, it is neither disturbance nor disruption, but an advancement based on experience, driven by committment and guided by the common goals of approachable experts.

Explore our perspective and platform at www.entimo.com