Providing on-hand, tailored support and expertise for your pharmacovigilance projects at every step of the clinical development pathway.
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 Periodic Safety Update Report (PSUR) 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 knowledgeable Pharmacovigilance Project Leaders will provide support and expertise throughout your journey with us.’
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 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.