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Medical Affairs

Our Medical Affairs team comprises of highly experienced medical, pharmacovigilance, patient access, patient advocacy and centricity, and bioethics professionals who work across all our early access programs, embedding a patient centred approach within our operational processes.

Medical Services

We have an experienced team of Physicians and Medical Writers who are dedicated to supporting Early Access Programs and Real-World Data.

Our services include:

  • Medical review of early access program requests
  • Medical pharmacovigilance (review of SAEs, etc)
  • Medical training (disease background, key safety considerations, eligibility criteria)
  • KOL engagement and advisory activities to support data collection
  • Medical Writing of EAP and RWD documentation such as protocols, ICFs and assent forms

 

‘Our highly experienced team work across all our early access programs, embedding a patient centered approach within our operational processes.’

Case studies

Global EAP for a specialized biotech company

Requirement for a global EAP of a rare disease on behalf of a US biotech partner.

Case Studies

Global Early Access Program Takeover

Rescue of a global oncology EAP on behalf of a large pharmaceutical company.

Case Studies

Guide the evolution of a pre-approval access policy for gene therapy (DMD)

Working with a top 20 pharmaceutical company to guide the evolution of their public policy for providing pre-approval access to gene therapy.

Case Studies