Early access & compassionate use Specialist CRO for AP and AC in France
ClinSearch has been supporting the pharmaceutical industry for more than 10 years in the implementation and monitoring of compassionate use and early access programs (EAPs). We have managed compassionate access (AAC), pre-marketing authorisation early access (AAP1) and post-marketing authorisation early access (AAP2) on behalf of pharmaceutical companies, from writing the therapeutic use and data collection protocol (PUT-RD) to the periodic reports submitted to the French National Authority for Health (HAS) and the French National Agency for Medicines and Health Products Safety (ANSM). Thousands of patients have accessed treatment via our platforms.
We've had the pleasure of collaborating with French governmental agencies
through working groups and a pilot related to early access. Our multidisciplinary team has extensive experience managing these programs and works within tight deadlines. Because we develop our access platforms in-house, without relying on third-party suppliers, we support programs that move from compassionate access (AC) to pre-authorisation early access (AP1), then post-authorisation early access (AP2), without disruption. We adapt each program to your needs and to the evolving regulatory landscape.
What we handle
ClinSearch manages the full lifecycle of early access and compassionate use programs in France, from dossier preparation to the reports submitted to the authorities:
- PUT-RD / PUT-SP writing and preparation of pre-submission meetings with HAS and ANSM.
- In-house access request platform: prescribers and pharmacists treatment requests and validations, instant messaging (secure and embedded), patient follow-up and real-time dashboards.
- Data collection as defined in the PUT-RD / PUT-SP, linked with existing databases such as the French National Rare Disease Database (BaMaRa) where the protocol requires it.
- Agreements with and payment of healthcare institutions taking part in data collection.
- Pharmacovigilance and safety reporting.
- Statistics: statistical analysis plan (SAP), programming and analyses.
- Periodic summary reports and synopses for HAS and ANSM.
- Dedicated helpdesk for prescribers and pharmacists.
A compliant platform
ClinSearch is the only CRO managing early access programs that is itself HDS-certified. This certification guarantees full compliance with the CNIL RS-003 and RS-004 standards.
Our Public References (since 1st of July, 2021)
Early access programs (HAS)
| Medicine (company) | Indication | PUT-RD |
|---|---|---|
| KEYTRUDAMSD | Triple-negative breast cancer (2021) | Link |
| Oesophageal cancer (2022) | Link | |
| Cervical cancer (2022) | Link | |
| Melanoma (2023) | Link | |
| Renal cell carcinoma, adjuvant (2023) | Link | |
| Urothelial carcinoma, with enfortumab (2024, 2025) | Link | |
| Cervical cancer, with chemoradiotherapy (2025) | Link | |
| HER2+ gastric adenocarcinoma (2025) | Link | |
| Bladder cancer (2026) | Link | |
| Head and neck cancer, neoadjuvant (2026) | Link | |
| PADCEVAstellas | Urothelial carcinoma, with pembrolizumab | Link |
| VYLOYAstellas | Gastric / gastro-oesophageal junction adenocarcinoma, pre-authorisation | Link |
| Same indication, post-authorisation | Link | |
| ENHERTUDaiichi Sankyo | HER2+ gastric / gastro-oesophageal junction adenocarcinoma | Link |
| HER2+ breast cancer, adjuvant | Link | |
| WELIREGMSD | Von Hippel-Lindau disease | Link |
| LIVTENCITYTakeda | Refractory CMV infection | Link |
| ZILBRYSQUCB | Generalised autoimmune myasthenia gravis | Link |
| KYGEVVIUCB | Thymidine kinase 2 deficiency | Link |
| SEPHIENCEPTC | Phenylketonuria | Link |
Compassionate access (ANSM)
| Active substance | Company | Status | ANSM page |
|---|---|---|---|
| Belzutifan | MSD | AAP and ATU discontinued AAC discontinued | Link |
| Maribavir | Takeda | AAP and ATU discontinued AAC discontinued | Link |
| Rozanolixizumab | UCB | AAP: unfavourable opinion AAC discontinued | Link |
Frequently asked questions
What is the difference between early access and compassionate use in France?
Early access (accès précoce) applies to a medicine the company is developing in the target indication and for which it commits to apply for marketing authorisation or reimbursement. It is granted by HAS, after an ANSM opinion for pre-authorisation early access (AP1). Compassionate access (AAC) is granted by ANSM, at a physician's request and for a named patient, when the medicine is not under commercial development in that indication. In both cases, the authorisation comes with a PUT-RD governing use and data collection.
What is a PUT-RD or a PUT-SP?
The therapeutic use and data collection protocol (PUT-RD) for APs, or the therapeutic use and patient follow-up protocol (PUT-SP) for ACs, specifies patient eligibility criteria, procedures for prescribing, dispensing, and follow-up, as well as the data to be collected. The pharmaceutical company is responsible for its implementation and submits periodic summary reports to the authorities.
Who should fund the data collection for early access?
The data collection required under the PUT-RD / PUT-SP is the responsibility of the operating laboratory. It funds the platform, compensation for healthcare facilities for the time spent on data collection, pharmacovigilance, and the preparation of summary reports. ClinSearch acts on its own behalf in all of these areas.
How do you move from AAC to AP1 and then AP2 without interrupting patient treatment?
French regulations provide for continuity of treatment when a program moves from one framework to another. Operationally, our platforms keep prescriber and pharmacist accounts, institutions and patient history; only the data collection forms are adapted to the new PUT-RD, and agreements with institutions are updated in parallel. Site teams don't have to start over.
Contact us today to discuss how we can help you streamline access and manage your programs efficiently.
Our solutions
PUT-RD writing
Study document drafting
Development of access programs and associated tools
Fully automated access request management
Contracting with sites
Site billing and payment, dedicated applications with dashboard reporting
SAP development, statistical programming
PV activities
Data analysis and reports for authorities
Resources
Senior clinical operations director
Global deputy operations director
Project leaders
Deputy project leaders
Research associates
Clinical safety officers
IT developpers
Data managers
Scientific & medical advisors
Statisticians
Medical writers
Helpdesk assistants
Activities
Project management
Treatment access
Helpline support
Remote monitoring
Reporting