OTHER SERVICES

EARLY ACCESS

Intsel Chimos specializes in facilitating early access, providing comprehensive support to pharmaceutical companies introducing therapies into the French healthcare system — before and also after Marketing Authorization.

Compassionate Use (Autorisation Accès Compassionnel – AAC)
For patients suffering from serious or life-threatening diseases with no therapeutic alternatives, compassionate use offers a vital channel to access promising treatments still under development. These programs are granted on a case-by-case patient basis outside of clinical trials.

Our Role in Compassionate Use:

  • Regulatory Expertise: We assist sponsors in navigating the regulatory framework for AAC submissions in France.
  • Medical Oversight: Ensuring compassionate use requests are aligned with clinical needs
  • Logistics and Supply: Coordinating the secure and timely delivery of pharmaceutical products.

 

Early Access Programs (EAPs)

The Autorisation d’Accès Précoce (AAP) provides early access to innovative medicines for patients with serious conditions and rare diseases.

Our Role in Early Access:

  • Regulatory Navigation: We ensure compliance with stringent EAP regulatory requirements.
  • Program Implementation: We assist in setting up and managing early access programs while liaising with health authorities.
  • Distribution: We ensure the efficient and compliant distribution of early access medications to healthcare providers.
  • Data Collection: Gathering real-world efficacy and safety data.

MARKET ACCESS

A strategic approach and market analysis is essential to ensure successful pharmaceutical market entry. It needs to be put in place well in advance of the launch of the product (be it under EAP or for products with a marketing authorization). This includes competition monitoring, price negotiations, and health technology assessments (HTAs). Also, our seamless transition services ensure uninterrupted availability of treatments from early access to full marketing.

Our Role in Market Access:

  • Strategic Planning: Tailored market access strategies aligned with the French healthcare system.
  • Pricing & Reimbursement: Preparation of comprehensive dossiers and engagement with authorities, aligned with the MAH (Marketing Authorization Holder).
ACCESS TO FRENCH MARKETS IN 7 STEPS

Intsel Chimos partners with your organisations across all stages.

CLINICAL TRIALS & DATA COLLECTION

At Intsel Chimos, we facilitate the execution of clinical trials, ensuring precise data collection and management, to validate the efficacy and safety of new treatments in real life. Our services are adapted to meet the specific requirements of each study and are fully compliant with the GDPR regulation.

Data Management
Accurate data collection and management are critical to maintaining the integrity of a clinical trial and/or the efficacy and safety of a treatment, within the framework of a managed access program. We utilize advanced electronic data capture (EDC platform) systems to ensure real-time data entry, validation, and monitoring. Our data management practices align with regulatory standards, ensuring accuracy, completeness, and verifiability.

Clinical Trial Distribution
We provide comprehensive distribution services within clinical trials, ensuring timely and compliant delivery of investigational products.

PHASES OF CLINICAL STUDIES​

Do you have a question ?

contact@intselchimos.com
+33 1 49 11 66 80
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