As of January 12th, 2025, JCA applies to ATMPs and oncology drugs, with orphan drugs following in 2028 and all remaining therapies by 2030. With JCA and EMA assessments running in parallel, early preparation is more critical than ever. One of the most powerful tools at your disposal? PICO simulation — ensuring your submission is both strategic and aligned with evolving requirements.
Once you have provided key inputs about your therapy and evidence package, PICO+ can assess, reference and swiftly generate a report
Input Data
You send us your asset’s description and intended indication
Data Matching
PICO+ matches inputs against data sets of 500+ drugs/indications from:
PICO Extraction
For matched drugs/indications, PICO+ extracts relevant data from HTA reports and clinical guidelines
Assessment
P4A assess individual PICO components based on returned HTA data and clinical guidelines
Scenario analysis
PICO+ conducts scenario analysis for different PICOs identified and the rationale for their inclusion
Report & Validation
We generate a report that includes details on the methodology, individual PICO components identified, the rationale for their inclusion and the source of the data which can be internally and/or externally validated by industry experts
Options range from a 2-day turnaround to a bespoke model that includes a user-friendly excel interface.
Single report – P4A led
Multiple reports – P4A led
Bespoke model
Lead time from initiation
Output
Bespoke outputs
Simulation updates
Customer time commitment
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