Bionical Group announces bionical-clinical early access programmes (EAP)

Early Access Programmes (often called Pre-approval Access, Compassionate Use, Named Patient, Expanded Access, Managed Access Programmes) deliver lifesaving treatments to patients around the world

Bionical Clinical EAP is the first global specialist Early Access Programme partner that harnesses the power of an established and successful Clinical Research Organisation while applying an understanding of the global EAP environment for the benefit of pharma clients, healthcare professionals and patients.

Bionical Clinical EAP in-house services include

  • EAP strategy, policy development and program design
  • Global regulatory expertise
  • Full pharmacovigilance services
  • High or low touch EAP delivery dependant on requirements enabled by full CRO model
  • Real World Evidence and Patient Reported Outcomes generation and utilisation
  • 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

"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", said Tom Watson, Executive Vice President, Bionical Clinical EAP.

Bionical has developed the ideal range of services to support Pharma and Biotech large and small

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

The whole area of access to investigational medicines has had a huge focus recently, being placed as a high priority for governments globally with patients around the world demanding earlier access to critical treatments.

"Having spent many years partnering with Pharma and Biotech companies in the Early Access 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,” concluded Watson.