While keeping patients safe is a common concern in the medical field, it is nowhere more important than in clinical trials. Our experts in pharmacovigilance and drug safety limit risk to trial participants, and report adverse events (AEs) in compliance with regulations to ensure patient safety.
From the start of trial preparation, drug safety forms a critical part of our clinical trial teams. We closely monitor the dosages administered to patients and watch for potential interactions to ensure trial participants are safe. Throughout the trial we collect and code Serious Adverse Events (SAEs) and examine Adverse Drug Reactions (ADRs), working with medical affairs to identify and evaluate short- and long-term risk factors. Our expertise extends to post-marketing and Phase IV, including:
Every drug is different, and the most powerful drugs often have the greatest potential for danger. Our multidisciplinary approach looks at all aspects of drug safety and focuses on developing solutions specific to each customer and communicating between all the specialists involved. This focus on communication extends to satisfying regulatory bodies, ensuring SAE reporting, Individual Case Safety Reports (ICSRs) and aggregate reporting are properly documented and meet government standards around the world.
We recognize that consistency is key to reliable results. With class-leading retention and expedited training, our drug safety teams are up and running quickly, constantly optimizing their operations and providing an unwavering focus on reducing risk to trial participants, patients and our customers.