Get in touch
Website Logo

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

Effective Pharmacovigilance & Regulatory EU and Australian Due Diligence, leading to operational and consultative support

A collaboration with US-based SME biotech client to recognize the full potential of their products, offering a significant therapeutic advantage to patients.

Case Studies

Global Oncology Phase 3 Rescue Study

Appointed to rescue a full-service, global, randomized Phase 3 oncology trial from a CRO failing to meet a biotechnology client’s expectations regarding enrollment and cost.

Case Studies

Operational Flexibility and Adaptability

The flexibility and adaptability required to successfully manage an operationally complex adaptive clinical trial.

Case Studies

How else can we help?

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

READ MORE

Regulatory Affairs

READ MORE

Medical Affairs

READ MORE

Early Access Programs