Early Access Programs - Bionical

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.

What we do

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
  • 24/7 multilingual medical, nurse and pharmacist support
  • Digital department and Insights Lab for EAP pathway design and request management system development
  • Tried and tested clinical QMS systems, state-of-the-art warehouse facilities, Quality Assurance and full licence structure

Why we do it?

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.

Having spent many years partnering with Pharma and Biotech companies in the EAP space, it is clear that Bionical has developed the ideal range of services to support Pharma and Biotech large and small. The Bionical ethos of ‘Improving Patient Outcomes’ represents a culture that has perfect timing within the current evolving EAP environment

Tom Watson, EVP Bionical Clinical EAP

How we do it

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.

Bionical's Other Services

Shortening of R&D timelines by efficient running of clinical trials

Shortening R&D timelines by rapid sourcing of supplies needed to run successful trials

Unique tools to enhance healthcare professional engagement

Expertise in the supply of specialist sales teams

Clinical services designed to change behaviors to enhance wellbeing

Using applied psychology and UX insight to create solutions that optimize user engagement

Specialist healthcare digital agency

Specialists in recruitment and executive search for sales and marketing jobs in healthcare

Do you have a question about this service?

Tom Watson

EVP Bionical Clinical EAP

+44 (0) 7741 625657