Early Access Programs

Early Access Programs

Bionical Clinical EAP is the first and only global specialist Early Access Program partner that harnesses the full power of an established and successful Clinical Research Organization whilst applying a deep understanding of the global EAP environment for the benefit of pharma clients, healthcare professionals and patients.
Our Early Access Programs (often called Pre-approval Access, Compassionate Use, Named Patient, Expanded Access, Managed Access Programs) deliver lifesaving treatments to patients around the world, whilst adding true value to our clients through a range of in-house additional cutting-edge services.

Our in-house services include:

  • EAP strategy, policy development and program design
  • Global regulatory expertise
  • Full pharmacovigilance services
  • High or low touch EAP delivery dependent on requirements enabled by full CRO model
  • Real World Evidence and Patient Reported Outcomes generation and utilization
  • Tried and tested clinical QMS systems, state-of-the-art warehouse facilities, Quality Assurance and full licence structure

We are deeply committed to improving patient outcomes for current and future generations and our goal is to provide timely and appropriate treatment access to patients in desperate need.

With the patient at the heart of everything we do, it is the blend of vast global EAP experience across hundreds of programs in Oncology, Rare and Neurodegenerative disease areas combined with a perfectly complimentary range of in-house services that sets Bionical Clinical EAP apart.

Experience has taught us that the best solution for a client is one that has been designed especially for them.

We create incentives for pharmaceutical and biotech companies to allow access to their products in development whilst mitigating risks and balancing traditional approval pathways.

Our digital and Real-World Evidence generation capabilities, Nurse Led services and extensive clinical experience allows us to design, create and run extremely tailored programs.

Whether you are in very early stages and looking to comply with 21st Century Cures Act Expanded Access requirements or ready to provide access to an investigational treatment during Phase II, Phase III, post-trial or beyond, Bionical Clinical EAP can provide the right solution.

 

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