Population Intervention Comparator Outcome
Expert-led, AI-enabled approach to help navigate the PICO maze for a successful JCA
Solving future challenges today
Enabling pre-pivotal study planning with a systematic approach to predicting and validating PICOs
Using the power of AI
Centralised data management enables a repeatable and iterative process incorporating landscape and evidence changes
Tailored to you
An individually tailored process to meet your asset/company needs for evidence planning and JCA submission
The time is now
The Joint Clinical Assessment (JCA) according to Regulation (EU) 2021/2282 (EU HTA) will initially be implemented for oncology drugs and ATMPs from January 2025 with a full roll-out by 2030.
All JCA procedures will begin with a scoping process leading to the development of a country-specific research question, represented as consolidated individual PICO schemes.
Patient population, intervention, comparator, and study endpoints to measure the outcome are determined by each authority as the basis for clinical evaluation.
Given the diversity of standards of care and availability of medicines across Europe, multiple PICOs can be expected. By simulating an EU HTA-based scoping process early in development we improve evidence planning to anticipate and manage complexity.
Engaging at any stage through development PICO PREDICT will allow teams to dynamically anticipate the PICO statement for individual countries and plan to meet diverging needs.
Using non-generative AI technology allows us to automate key aspects of this process and to replicate them on demand - enabling truly dynamic assessment efficiently and quickly as the environment and evidence evolve.
Combining this with a global expert network for validation and the ability to formulate and deliver SLR protocols swiftly and accurately PICO PREDICT will ensure companies are optimally prepared for HTA around the world.