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Pharmacovigilance

Our dedicated Early Access Program Pharmacovigilance team provide on-hand, tailored support and expertise.

Experts you can trust

We understand the importance of having a Pharmacovigilance team you can trust and have experts on hand to support you every step of the way.  In addition to our dedicated Case Management Team, you will also be assigned to one of our knowledgeable Pharmacovigilance Project Leaders who will provide support and expertise throughout your journey with us.

‘Our knowledgeable Pharmacovigilance Project Leaders will provide support and expertise throughout your journey with us.’

Our Pharmacovigilance services include:

  • Full or partial ICSR management
  • Preparation of Safety Data Exchange Agreements (SDEAs) or Pharmacovigilance Agreements (PVAs)
  • Expedited reporting
  • Centralization of safety data
  • Global and local literature search and review
  • Aggregate report preparation and submission
  • Signal management

Case studies

Supplying our top 10 US pharma client with local language comparator and ancillary product

Locally sourcing, storing and distributing comparators and ancillaries for a global phase 3 study.

Case Studies

European EAP with tailored RWD strategy

Rapid set-up of EAP for a rare oncology product.

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

How else can we help?

Discover more about the services and capabilities Bionical Emas has to offer

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Early Access Programs