Supporting pharmacovigilance during global expansions
Catalyst Oncology contracted for studies across several indications and countries. As the pharmaceutical client’s needs grew, Catalyst met and exceeded the needs of the client’s expansion plans, including global pharmacovigilance services.
The challenge
The Safety team at Catalyst Clinical Research has had the opportunity to support an array of clients with Phase I to Phase III studies, including an active study in South Korea. The following case study illustrates how Catalyst supported this client’s pharmacovigilance services over several years as they expanded outside the United States and into other regions.
The solution
Catalyst worked with a pharmaceutical client to provide case processing and cross-reporting services across multiple Phase I and Phase III studies.
To date, the Safety team has supported this pharmaceutical client with providing the global safety database and case processing of serious adverse events (SAEs) and adverse events of special interest (AESIs) for
The outcome
Due to the expedited nature of these protocol startups, Catalyst had to exhibit flexibility with timelines and resources to meet the client’s deadlines.
Catalyst collaborated with eight different clinical CROs contracted to provide clinical services for these studies. Due to the various clinical CROs involved, Catalyst collaborated and cross-reported suspected unexpected serious adverse reactions (SUSARs) to the CROs and to unblinded individuals without compromising Catalyst regulatory compliance.
Additionally, this client expanded into two indications, two formulations, and two investigational new drug applications (INDs) requiring another level of expertise in safety reporting, which Catalyst Clinical Research’s Safety team successfully guided the client through.
