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Medical Affairs

Our Medical Affairs team comprises of highly experienced medical, patient advocacy, insights specialist and bioethics professionals who work across all our clinical development and early access programs, embedding a patient centered approach within our operational processes.

Medical Services

We have an experienced team of physicians who work closely together with our clients and investigators on all the programs that we support.

Our services include:

  • Medical monitoring of Phase 1 – 4 clinical studies (protocol review, IDMC, lab listings etc)
  • Medical review of early access program requests, protocols and ICFs/PAFs.
  • Medical pharmacovigilance (review of SAEs, AOSE, PBRER etc)
  • Strategic medical consultancy
  • Medical training (disease background, key safety considerations, eligibility criteria)
  • Medical review of promotional and education materials

 

‘Our highly experienced team work across all our clinical development and 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