EU Joint Clinical Assessment

Anticipate payer and EU HTA requirements, optimize clinical evidence positioning across consolidated PICO scopes, and sequence analyses to JCA timelines.

Integrate JCA methodology into development and launch planning by stress-testing PICO scenarios, mapping critical-path risks, and preparing for Joint Scientific Consultations (JSCs).

Support Joint Scientific Consultations (JSCs) with tailored evidence strategies, coordinating cross-functional input and aligning RWE plans with HTA expectations.

Gather insights from affiliates to inform potential cross-market implications and analyze impact on launch strategy.

Develop clinically anchored value narratives that clearly articulate efficacy, safety, and unmet need within the JCA framework, while ensuring seamless adaptation for country affiliates.

Translate clinical evidence into structured JCA dossiers that meet HTA Coordination Group requirements, ensuring consistency across SmPC, clinical overview, and ITC outputs.

Rapidly identify evidence gaps and provide tailored evidence generation solutions to support JCAs, leveraging our in-house automation capabilities and tools. Combined with LCP’s expertise in ITCs, NMAs, ECA feasibility, and automated SLRs, this approach delivers robust, decision-relevant evidence that covers all relevant PICOs for EU JCA.

Economic modeling support: While economic evaluation is not part of the JCA process, we develop early economic models to inform strategic planning for future HTA submissions. By integrating clinical trial data, real-world evidence, and scenario-based assumptions, we help support our clients with value narratives and by anticipating payer perspectives.

Consolidating insights from EUnetHTA joint actions and providing ongoing EU-27 intelligence updates and newsletters to ensure teams remain aligned with evolving guidance and best practice.

Simulate PICO scenarios to optimize evidence strategy, anticipate comparator and outcome requirements, and align trial design and RWE plans with the evolving scope of EU JCA assessments.