Providing support every step of the way.
Our experience extends from oncology to endocrinology, and from medical devices to ATIMP (Advanced Therapies). In addition to our dedicated Case Management Team you will also be assigned to one of our experienced Pharmacovigilance Project Managers.
Our in-house safety database, is fully compliance the FDA and EU requirements and provides great value for money for our clients. Alternatively, our Case Management Team have experience in a variety of safety databases and can enter directly into your system.
We understand that pharmacovigilance regulations are complex and constantly evolving and will ensure that you are fully compliant with all requirements. We pride ourselves on providing a robust, personal service to our clients; supporting you every step of the way.
The success or failure of a clinical trial relies heavily on accurate data. Our years of clinical trial experience mean our Pharmacovigilance Team work to ensure that you are fully compliant with Good Clinical Practices (GCP) and pharmacovigilance regulations to ensure your data is of sound quality.
We frequently manage the assembly of DSMBs (Drug Safety Monitoring Boards) on behalf of our clients. 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 I–IV. Alternatively, we can provide stand-alone Pharmacovigilance support for your studies.
After achieving a marketing authorization for your pharmaceutical product, the safety requirements set out by regulatory authorities’ change considerably. We can walk you through this process and provide additional resources, assisting with specific activities such PSMF (Pharmacovigilance System Master File) creation, case processing, expedited reporting, writing and submitting periodic safety update reports (PSURs), scientific literature monitoring, signal management and much more.
With a number of highly skilled and experienced Pharmacovigilance experts within our team, we can adopt the role of EEA Qualified Person for Pharmacovigilance to our clients and the additional management of LQPPVs. As well as fulfilling this crucial role, their expertise and experience will prove to be invaluable in providing specialist medical and scientific assistance such as the production of the PSMF, risk management plans (RMPs), Safety Data Exchange agreements (SDEAs), responding to regulatory requests, and assisting in responding to safety concerns.
Services we provide:
- Full or partial ICSR management
- Expedited reporting
- Device Vigilance
- Pharmacovigilance provision for Named Patient Programs (NPPs) or Early Access Programs (EAPs)
- Global and local literature search and review
- Aggregate report (DSUR/PSUR) 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)