MadeAi-JCA
An AI Platform for EU Joint Clinical Assessment
Anticipate the PICO Scope. Build the Evidence. Start Early.
MadeAi-JCA maps comparators and standard of care across all 27 EU Member States, identifies relevant outcomes, generates anticipated PICO sets, and runs the systematic literature reviews behind them – everything your team needs, in one place, fully traceable.
The MadeAi-JCA Difference
1
Integrated Platform
70%
Time Savings
50–60%
Cost Savings
100%
Traceability
Anticipatory JCA Scoping, Connected to Evidence Synthesis
Use the period before the official PICO scope arrives to investigate country-specific comparators and outcomes, review anticipated PICO sets, and begin evidence synthesis. Once the official scope is issued, reconcile the prepared evidence with confirmed requirements.
Start Preparing Earlier
Develop and review anticipated PICO sets before the official scope arrives to plan evidence work earlier.
Cover Every Country
Investigate comparators and standards of care across all 27 EU Member States using tiered sources and expert review.
Identify Evidence Gaps
Systematic sourcing and traceable outputs help teams identify evidence gaps and prepare material for expert review.
Documented Reviews
Human review checkpoints, documented actions and AI-use reporting support transparent dossier preparation.
One Integrated Workflow
Scoping, literature review, extraction, and synthesis in a single platform. Connect anticipated scoping with evidence synthesis.
From Your Product Profile to Submission-Ready Evidence in Four Steps
Define the product
Enter the target population (disease, age group, stage) and intervention details (name, dose, line of therapy, route).
Generate comparators and outcomes
Identify potential comparators and outcomes for expert validation, with supporting sources and rationale.
Generate PICO sets
Generate anticipated PICO sets with Member State context. Review, edit, and approve before locking.
Run the literature reviews
Run literature reviews for each PICO set, covering search, screening, extraction, and synthesis with expert validation.
What You Get With MadeAi-JCA
JCA Scoping
Map standard of care across 27 EU Member States.
- Comparator intelligence
- Outcome identification
- Anticipated PICO sets
- Source-linked rationale
Evidence Synthesis
Connect each PICO to a structured literature review.
- Search and screening
- Data extraction
- Risk of bias assessment
- Traceable evidence summaries
Governance and Compliance
Keep experts in control of AI-assisted outputs.
- Human review and approval
- Documented audit trail
- AI disclosure support
- Source traceability
Validated Against Published JCA Report
MadeAi-JCA was evaluated against three published EU Joint Clinical Assessment reports spanning different indications and complex PICO requirements. In this preliminary validation, the platform demonstrated strong comparator identification and core outcome coverage, and generated source-linked anticipated PICO sets in under one hour, giving HEOR teams a traceable starting point for expert review. Performance may vary by indication, and specialists finalize the anticipated scope.
Comparator identification
10 of 11 JCA-defined comparators identified
Core outcome coverage
OS, PFS, ORR, safety, and HRQoL in all three cases
PICO sets captured
Complex sub-populations identified; expert label confirmation remains necessary
Draft scoping output
Compared with an estimated 3–5 weeks of manual specialist effort
Who MadeAi-JCA Is For
Market Access and HEOR Teams
Plan JCA evidence strategy, identify country-specific comparators and outcomes, and develop anticipated PICO sets to guide evidence preparation.
Regulatory Affairs Teams
Align JCA preparation with marketing authorization timelines and coordinate requirements once the official scope is issued.
Medical Writers and Systematic Reviewers
Carry PICO requirements into literature reviews, extraction, and source-traceable evidence synthesis.
Medical Affairs and Evidence Generation Teams
Contribute clinical context and support early evidence planning alongside Market Access and HEOR.
HEOR Consultancies and CROs
Support pharmaceutical clients with structured JCA scoping and evidence synthesis in a shared workflow.
Who Needs to Prepare, and When
Oncology medicines and advanced therapy medicinal products
JCA begins with new cancer medicines and advanced therapy medicinal products covered by the EU HTA Regulation.
Orphan medicines
Developers of orphan medicinal products enter the JCA process.
All centrally authorized medicines
The JCA scope expands to the remaining centrally authorized medicinal products covered by the regulation.
Choose the Right Engagement Model
Do-It-Yourself
Software as a Service
Done-For-You
Hybrid: Software + SME
Build–Operate–Transfer
Customized Version
Choose which option or combination of support models works best for your business.
Case Studies & Scientific Research
Ready to prepare for the EU Joint Clinical Assessment?
MadeAi-JCA is an AI-powered, expert-validated platform built for life sciences teams preparing JCA dossiers. See how anticipatory scoping and traceable literature reviews fit your timeline.
FAQ
The Joint Clinical Assessment is a single EU-level review of a new medicine’s clinical evidence that covers all 27 Member States at once. It runs in parallel with EMA regulatory approval under the EU HTA Regulation (2021/2282). Regulatory approval asks whether a medicine is safe and effective. JCA asks how it compares with the treatments already used in each country. Since January 2025 it applies to oncology medicines and ATMPs, from 2028 to orphan medicines, and from 2030 to all centrally authorized medicines.
MadeAi-JCA is an AI-powered platform built for the JCA process. It helps manufacturers identify comparators, standard of care and outcomes across all 27 Member States, generate the PICO sets assessors are likely to issue, and run the systematic literature reviews behind them in one traceable workflow. Outputs are designed for human review and further validation before dossier use.
Once the HTA Coordination Group issues the official PICO scope, a manufacturer has 100 days to submit the dossier, leaving limited time to reconcile the evidence with the confirmed scope. Each PICO set may need its own systematic literature review. MadeAi-JCA supports early scoping and evidence preparation so teams can concentrate on reconciling results with the official scope.
The platform scans tiered sources, including national HTA reports and benefit assessments, clinical guidelines, drug registries and product labels, published literature and clinical trial registries across the EU and US. For each comparator and outcome it shows which Member States it applies to, the source tier and a rationale, and links to the exact source document. Users can review, edit and add their own.
MadeAi-JCA brings anticipatory JCA scoping and evidence synthesis into a connected workflow. Teams can investigate country-specific comparators and outcomes, review proposed PICO sets and initiate literature reviews without treating scoping and synthesis as separate projects.
The platform is built around the HTACG principles of accountability, transparency and reporting for AI use in JCA dossier preparation. Every stage has a human approval gate, every AI action and human edit is timestamped in an audit trail, and the platform exports AI disclosure documentation that can accompany the dossier.
Yes. Data extraction covers text, tables and figures, including forest plots, Kaplan-Meier curves, bar charts, patient flow diagrams, Sankey diagrams, line charts and pie charts, with source-linked results for expert verification. Figure-derived estimates should be checked by a reviewer before use.
Request a demo and the MadeAi team will walk you through anticipatory scoping for your product and indication. You can run the platform with your own team, work with MadeAi experts in a done-for-you model, or deploy a customized version through build-operate-transfer.