ABOUT Pharmacovigilance
Experts you can trust
Our Pharmacovigilance services include:
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. We provide services for short-term projects such as a Phase 1 Clinical Trial or preparation of a Developmental Safety Update Report (DSUR) and long-term projects such as the establishment and operat
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. We provide services for short-term projects such as a Phase 1 Clinical Trial or preparation of a Developmental Safety Update Report (DSUR) and long-term projects such as the establishment and operation of a Global Pharmacovigilance System during the development of the product (centralized CT safety database), or in the lead into submission and approval of a product.
Our Team
Our Pharmacovigilance services include:
Experts you can trust
Our experience extends from oncology to endocrinology, and from Early Access Programs to ATIMPs (Advanced Therapies). 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 in-hous
Our experience extends from oncology to endocrinology, and from Early Access Programs to ATIMPs (Advanced Therapies). 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 in-house safety database (Veeva Vault Safety) is fully validated and compliant with the FDA and EU requirements and provides great value for money for our partners. Alternatively, our Case Management Team have experience in a variety of safety databases and can enter directly into your system.
We frequently manage the assembly of DSMBs (Drug Safety Monitoring Boards) on behalf of our partners. We also work closely with our Clinical Operations Team to deliver a full-service clinical trial solution for your investigational medicinal product all the way through Phase 1–4. Alternatively, we can provide stand-alone pharmacovigilance support for your studies and Early Access Programs.
Our Pharmacovigilance services include:
Our Pharmacovigilance services include:
Our Pharmacovigilance services include:
- Full or partial ICSR management
- Regulatory reporting
- Provision of central safety database
- Global and local literature search and review
- Aggregate report (DSUR/PSUR/PADER) preparation and submission
- PSMF preparation and maintenance
- EU QPPV and network of local QPPVs/PV responsible people
- EudraVigilance and XEVMPD registration
- Signal management
- Rev
- Full or partial ICSR management
- Regulatory reporting
- Provision of central safety database
- Global and local literature search and review
- Aggregate report (DSUR/PSUR/PADER) preparation and submission
- PSMF preparation and maintenance
- EU QPPV and network of local QPPVs/PV responsible people
- EudraVigilance and XEVMPD registration
- Signal management
- Review of regulatory documents (including RMP, CCDS, IB, Protocol)
- Preparation of Safety Data Exchange Agreements (SDEAs) or Pharmacovigilance Agreements (PVAs)
- Regulatory Intelligence support