Long-term global pharmacovigilance assistance
Catalyst Oncology provided a range of pharmacovigilance services for an active global study. The contracted services supported nine protocols across several continents. The Safety team also engaged with several governing healthcare entities to facilitate and manage submissions.
The challenge
Catalyst Clinical Research has supported many clients with Phase I to Phase III studies, including the active global study described in this case study. For this client, the Catalyst Safety team developed a plan for broad and long-term pharmacovigilance services for a rescue opportunity outside the United States.
The solution
Catalyst Clinical Research entered into an agreement with a pharmaceutical client to provide pharmacovigilance services for two investigational medicinal products (IMP) across nine clinical trials and multiple other compassionate use protocols, named patient programs, and expanded access programs.
This was a rescue opportunity where the Catalyst Safety team transferred cases from the previous safety vendor’s database into the client’s Veeva Vault Safety System (VVSS).
The outcome
Of the nine protocols, two were Phase III studies with sites in North America, Latin America, Europe, the United Kingdom, the Middle East, and the Asia-Pacific region, including South Korea. In addition to migrating the legacy cases, Catalyst supported this client with suspected unexpected serious adverse reaction (SUSAR) and developed safety update report (DSUR) submissions to regulatory authorities.
Catalyst submitted SUSARs to Health Canada, the European Medicines Agency (EMA) via EudraVigilance, and the Medicines and Healthcare Products Regulatory Agency (MHRA). Additionally, the Catalyst Safety team collaborated with the client’s various clinical and regulatory vendors in other countries to facilitate local SUSAR submissions to the sites and regulatory authorities where a local entity was required to perform the submission.
We assisted the client in achieving market approval in the United States and Europe. Catalyst worked with our partners to provide a qualified person responsible for pharmacovigilance (QPPV) support and for developing the pharmacovigilance system master file (PSMF) as required by the EMA. Catalyst continued supporting this client with pharmacovigilance services, including clinical trial and post-market case processing and reporting.
