Viewpoints 

The EU Joint Clinical Assessment Challenge

The European market is essential for mid-market biotech and pharma companies aiming for international growth. However, navigating the regulatory landscape has historically been fragmented, with separate submissions to each European Union (EU) country's Health Technology Assessment (HTA) body. 

The EU Joint Clinical Assessment (JCA) (Regulation EU 2021/2282) introduces a centralized assessment process that harmonizes clinical evaluations across the EU. While this is an improvement, it presents new challenges: 

• Accelerated timelines: Companies must now submit their clinical dossiers 45 days earlier than before. 

• Increased evidence complexity: JCA requires comprehensive PICO (patient, intervention, comparator, outcomes) frameworks, including multiple PICO schemes for diverse clinical questions. 

For mid-market biotech and pharma companies, this means higher pressure to produce more robust evidence in a shorter timeframe. 

How Dr.Evidence Solves the JCA Challenge

Dr.Evidence’s fit-for-purpose solution can help mid-market companies navigate these changes and comply with the JCA submission process. Consider these key benefits for mid-market companies: 

 More Robust Evidence Preparation: 

• Comprehensive and contemporary market landscape view combines drug labels, regulatory approval packages, guidance documents, clinical trials, and scientific literature into a single source, saving time on manual and time-consuming data gathering and synthesis. 

• Tailored workflows enable teams to conduct prior precedent research and generate competitive intelligence to produce comprehensive and accurate evidence from across the market landscape. 

• Access to max.intel, our unlimited complimentary white glove search optimization service delivered by Client Success domain experts who help you customize your platform queries to generate the most relevant results.  

Accelerated PICO Framework Development: 

• Direct interaction with max.ai, our proprietary generative AI (large language) model, combined with more than 25 other robust large language, machine learning and natural language processing models. This supports rapid and efficient development of multiple PICO frameworks and helps meet JCA's increased evidence requirements. 

• Ability to rapidly and accurately ask and answer PICO-based questions across scientific literature, clinical trials, congresses, and beyond. 

Enhanced Decision Making: 

• AI-powered Insights help companies quickly identify gaps in evidence, address regulatory concerns, and refine submission strategies in days rather than months. 

Automated Monitoring and Notifications When New Evidence Is Introduced: 

• Automated monitoring and notifications help companies stay on top of landscape changes across drug labels, regulatory approval packages, guidance documents, clinical trials, and scientific literature to ensure evidence is current  

Cost-Efficiency & Scalability: 

• Mid-market companies with limited resources can efficiently prepare evidence without large teams or expensive consultants, ensuring faster and more cost-effective submissions. 

Dr. Evidence: A Game Changer for Mid-Market Companies with a Global Footprint

With Dr. Evidence, mid-market biotech and pharma companies can stay ahead of the JCA curve, deliver compliant and well-supported evidence, and accelerate access to the European market. This streamlined solution allows companies to focus on growth without getting bogged down in complex regulatory hurdles, risking delays in market access and commercial launch with significant revenue loss implications.