Clinical Services Safety & Pharmacovigilance

Safety and Pharmacovigilance

CTI offers an interactive approach to global safety and pharmacovigilance. The CTI global Safety and Pharmacovigilance team has broad experience with a variety of databases and technology, in addition to concentrated experience with critically ill patients participating in global studies and numerous years of industry experience.

Shelly Brewer, RN, BSN, MBA
Director, Global Safety & Pharmacovigilance
Shelly has nearly 25 years of clinical and industry experience, including multiple years as a pediatric nurse. Her vast expertise in global safety and pharmacovigilance, including case management, safety systems, client relations, and personnel management, contributes to successfully run trials around the world.

Shelly Brewer

Our Safety and Pharmacovigilance team excels at developing and maintaining interactive and multi-disciplinary relationships within the study team, with the goal of efficiently processing safety data by keeping key people involved and coordinating communications to sites to limit redundancy. This leads to rapid identification of any potential safety issues and resolution of any open events. The diligence and attention our sponsors receive from CTI’s Safety and Pharmacovigilance team is unique in the industry.

CTI utilizes industry leading safety software systems to store and monitor adverse events (AEs) encountered in clinical trials. Each safety event is reviewed in detail and sites are queried regarding discrepant information. Additionally, sites are contacted routinely for updates to ensure that the information entered and reported is as accurate and timely as possible. On an ongoing basis, members of the Safety and Pharmacovigilance team meets with the CTI Medical Affairs team to review AEs and Severe Adverse Events (SAEs) listings in aggregate for the trial to evaluate trends, emerging safety signals or cause for further investigation.

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