Deliver the EU Joint Clinical Assessment on time. Without the 100-day fire drill.
One workspace for your whole team to scope every PICO across up to 27 Member States, close the evidence gaps and build the Annex I dossier. No missed PICOs, no last-week scramble — just the dossier, delivered before the clock runs out.
The first EU JCA reports are being published now, in June 2026. The deadlines are real.
(60 if accelerated)
The JCA is mandatory. The clock runs to 100 days. No tool was built for it.
One joint clinical assessment now feeds the national HTA processes of up to 27 Member States, and most teams are running it on Word, Excel and shared drives. Member States write the PICOs; you cannot negotiate them. You answer every one, in full, before the clock runs out.
The PICO explosion
One oncology submission can mean 10 to 30+ country-specific PICOs and hundreds of analyses, with subpopulations splitting by histology or biomarker. No spreadsheet holds that cleanly.
Evidence scattered everywhere
Clinical data, systematic reviews and indirect comparisons sit across Word, Excel and email threads. None of it is easy to reuse, version or defend per PICO.
Fragile cross-functional work
Regulatory, Market Access, HEOR and Biostatistics now share one deadline with no shared source of truth, version control or audit trail.
No clock stops
Miss a PICO and the completeness check returns the dossier while the clock keeps running. A weak answer reaches all 27 Member States, which must give the report "due consideration".
How a Joint Clinical Assessment runs, and how JCA Studio hits every deadline.
One EU assessment now feeds reimbursement decisions in up to 27 countries. It runs on a fixed clock with no stops, from the moment the Commission sends the scope to the day the report is published. This is the real procedure, and where JCA Studio keeps you on time.
Scope & PICOs
Member States set the assessment scope and the PICOs in the Commission's first request. You cannot negotiate them. One oncology file can carry many PICOs across populations and comparators, often eight or more.
Model every country PICO as structured data the moment the first request lands, and see comparator and subgroup divergence before the clock starts.
The 100-day dossier
From the first request you have 100 days, or 60 if the EMA review is accelerated, to submit the full Annex I dossier, and never later than 45 days before the CHMP opinion. There are no clock stops, not even if the indication changes.
Back-plan from the CHMP date, assemble the six-section dossier in parallel, and track every PICO answer against the day count so nothing slips.
Completeness check
The Commission checks the dossier is complete within 15 working days. Miss a required PICO answer or table and it returns for a second request, while the clock keeps running.
A live completeness check flags every unanswered PICO and missing evidence table before you submit, so you pass the first time.
Assessment & clarifications
The assessor and co-assessor write the report and can send clarification requests on 7-to-30-day deadlines. An assessment often runs more than one request-and-response round across several dossier versions.
Keep every analysis, source and version in one auditable place, so you turn each clarification around in days, not weeks, with a clean trail.
The endorsed report
The endorsed report sets out relative effectiveness and its uncertainty, per PICO, for every Member State to give due consideration. It does not decide price or reimbursement; your national HTA bodies do, using this report.
Export a platform-ready package and keep the evidence trail your national submissions reuse, so the JCA feeds your market access instead of restarting it.
The scale inside one published EU JCA report:
That is a single assessment, and only one PICO had usable comparative data. JCA Studio is built to run it, on the clock.
Predicting your PICOs is predicting comparators — country by country.
Population follows your label and outcomes share a common core across Europe. The comparator is the hard part — roughly 80% of the work. Every Member State selects it with its own rule, filtered by what is reimbursed and shifting over time.
One workspace for the whole JCA workflow.
From the consolidated scope to an Annex I-conformant dossier, your submission team works in one auditable environment, with AI assistance where it earns its place.
PICO-by-country matrix
Model every PICO per Member State as structured data. See subpopulation splits and comparator divergence before formal scoping.
Evidence library & gap tracker
A searchable repository of studies and analyses you build once and reuse. See, per PICO, whether the dossier can answer it.
Annex I dossier builder
Assemble a template-conformant dossier across the six required sections, with a completeness check that catches failures before submission.
100-day clock orchestration
Track every milestone against the no-clock-stop timeline and the parallel EMA procedure: completeness checks, second requests and factual-accuracy windows.
Collaboration & audit trail
RA, HEOR, Biostatistics and Medical work in one space with roles, approvals and a versioned, attributable record for CSV / Annex 11.
EU platform export & API
Assemble a package formatted to the EU HTA IT Platform's requirements, with a redaction view, for your team to review and submit. Connect your stack via API.
Six screens, one JCA workflow.
An early look at the interface, from the country-PICO matrix to the EU platform export. Open each of the six screens with the tabs below.
Illustrative product preview. Data shown is fictional and for demonstration only; JCA Studio is in early access.
AI that assists. Never decides.
JCA Studio uses AI and automation to cut the manual work in the dossier, while a qualified expert reviews and signs off every output. That is the human oversight EMA and ISPOR call for.
AI proposes search terms, de-duplicates and ranks abstracts across MEDLINE and Cochrane CENTRAL. A reviewer confirms every include and exclude.
Anticipate likely Member-State PICOs and flag which ones lack head-to-head or indirect evidence, before formal scoping closes.
First-draft prose for Annex I sections from structured inputs, plus contradiction-spotting across the dossier, EMA file and PICO answers.
Every AI-drafted line in the Annex I dossier links back to the exact source it came from, down to the study, page and table. Click any claim to see its evidence and its full edit history.
JCA Studio is a human-in-the-loop tool. It assists experts and makes no autonomous clinical or regulatory decision, so on a reasoned reading it sits outside the AI Act's high-risk tier. We meet the transparency duties, label where AI is used, and align with EMA's reflection paper on AI and ISPOR's guidance on human oversight in HTA. No certification scheme exists for this tier, so we do not claim one.
What AI and automation give your team back: time on the clock.
The 100-day clock never moves. AI and automation move the work that fills it, so a lean team can answer a larger scope without missing the deadline or burning out.
AI screening collapses weeks of manual abstract triage into days, so your reviewers spend their time judging evidence, not hunting for it.
Draft-assist turns structured inputs into first-pass Annex I prose in hours, leaving experts to refine rather than write from a blank page.
Automation across the country-PICO matrix lets a lean team answer a larger, combinatorial scope inside the fixed 100-day window.
Today, oncology. By 2030, every new medicine.
Oncology medicines and ATMPs. JCA in force since 12 January.
First joint reports landing now · June 2026Orphan medicinal products join the scope on 13 January.
All new centrally authorised medicines, from 13 January.
The system is live and the deadlines are real. Today's tools stop at PICO prediction; none run the assessment end to end.
JCA-native, end to end.
Live in days instead of a six-month rollout. JCA Studio covers the country-PICO matrix through to the EU platform export, the gap your current stack leaves open.
| Capability | JCA Studio | Veeva / full RIM | PICO-prediction tools | Word · Excel · consultancy |
|---|---|---|---|---|
| Purpose-built for the JCA | ●Native, end-to-end | ○Built for eCTD, not JCA | ◐PICO front-end only | ○Manual |
| PICO-by-country to assembled dossier | ●Built in | ○No PICO model | ◐Predicts, doesn't assemble | ○Spreadsheets |
| 100-day clock orchestration | ●Built in | ◐Generic workflow | ○None | ○Manual tracking |
| Time to live | Days | 6+ month rollout | Weeks | Immediate but unstructured |
| Relative cost | A fraction of a RIM | Enterprise pricing | Module / suite | High day-rates |
Veeva runs your eCTD; it doesn't run your JCA. PICO-prediction tools stop at the scope. JCA Studio owns the workflow in between.
Generic AI writing platforms turn inputs into prose. They do not model the PICO-by-country matrix, comparator divergence across Member States, the 100-day clock, or the export to the EU HTA IT platform. JCA Studio is built on that structure, so drafting is the last step, not the whole product.
Security and compliance for a regulated buyer.
EU data residency
Built to be hosted and processed in the European Union, with GDPR-aligned data processing terms.
Validation-ready
Audit trails, access control and documented change management that support your CSV and Annex 11 obligations.
AI transparency
Every AI-assisted output is labelled and routed through human sign-off, designed to meet the AI Act's transparency duties.
SSO & API integration
Single sign-on, role-based access, and an API to connect your RIM, literature sources and analytics stack.
On the security roadmap: a public Trust Center, SOC 2 Type II, and a live status page. We will publish progress rather than claim badges we have not earned.
Your data never leaves your perimeter.
JCA Studio deploys a data ingestor inside your own infrastructure. It reads your local systems securely, over API or MCP, and only structured extracts and references cross to the JCA Studio cloud. Full documents and patient-level data stay with you.
The ingestor reads only what you authorise, where your data lives.
Beyond the clinical and regulatory systems above, the JCA Studio Data Ingestor connects to any source you authorise: SharePoint, network file shares, document management systems and data lakes, each behind your own access controls. It runs retrieval-augmented generation with local models inside your perimeter, indexing and extracting only the evidence relevant to each PICO. Raw documents, source files and patient-level data never leave your network; only de-identified structured extracts and references cross to the EU cloud.
Real documents and patient-level data never leave your network. The connector runs where your data already lives.
The JCA Studio cloud receives structured extracts and references to assemble the dossier, never your full source documents.
Every pull from a local system, over API or MCP, is encrypted, access-controlled and written to an immutable audit log.
Customer data, JCA databases, identity, audit, the agentic AI services and the vector and metadata stores run as isolated, independently secured services.
- Encryption in transit and at rest, with optional customer-managed keys (BYOK).
- Per-tenant isolation keeps each customer's data and workspace separate.
- Sensitive embeddings stay on-prem; only de-identified extracts are indexed in the cloud.
- RAG guardrails: whitelisted sources, PII detection and redaction, prompt-injection mitigation.
- GDPR controller / processor terms (Art. 28 DPA) and DPIA support for your assessment.
- Immutable, time-stamped audit trail, ALCOA+ aligned for GxP and Annex 11.
The clock is already running on the first JCA cohort.
If you have an oncology or ATMP assessment underway or on the horizon, the teams who prepare early set the precedent. See JCA Studio before your next scope lands.
Back the JCA category at the start.
JCA Studio is an early-stage bet on a market the EU has made mandatory. The Joint Clinical Assessment is law, its scope widens to every new medicine by 2030, and no incumbent owns the workflow yet. We are validating demand now and talking to aligned investors who want in early.
A regulation-made market
Demand is driven by EU law, not a sales cycle. Oncology and ATMPs today, orphan drugs in 2028, every new centrally authorised medicine by 2030.
An open first-mover lane
RIM suites run the eCTD and PICO tools stop at the scope. JCA Studio is built to own the assessment workflow in between, end to end.
Built by Stradiax
An operator team shipping AI products for regulated industries, with EU hosting, audit trails and compliance designed in from day one.
For investors exploring an early stake. We will share the materials and the demand data under NDA.
Pricing built around your submission load.
Final pricing is being shaped with early-access partners. Join the program to help define it.
Starter
For a single, time-critical JCA.
- One active assessment
- PICO-by-country matrix & 100-day clock
- Annex I builder & EU export
- Up to 5 users
Growth
For teams with a recurring pipeline.
- Unlimited assessments
- Reusable evidence library & gap tracker
- AI Agents & cross-functional audit trail
- API access & priority support
Enterprise
For global organisations & consultancies.
- Multi-entity & client workspaces
- SSO & advanced security
- Validation support (CSV / Annex 11)
- Dedicated onboarding
Questions we get.
What is the EU Joint Clinical Assessment (JCA)?+
What is a PICO in HTA?+
What is the EU HTA Regulation (HTAR)?+
Is this Veeva?+
Where is my data stored?+
Is it validated (GxP / CSV)?+
Is it EU AI Act compliant?+
Does it integrate via API?+
When is it available?+
How is this different from hiring a consultancy?+
Will our submission data be used to train AI models?+
How do you keep the AI output trustworthy?+
Can we start with a single assessment?+
How much does it cost?+
Who is behind JCA Studio?+
Request early access to JCA Studio.
Tell us what brings you here and where you are with the JCA. We reach out to qualified teams first.
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