Clinical Operations-Design to Execution

BayBiotech.NET In a clinical study, patient focus is central to the success and a patient centric study design and considerations can not be undermined. From start-up phase to maintenance until a study close-out, successful patient enrollment within timelines recruiting right population, safety and efficacy of the patients is a key sponsor and regulatory consideration. Any lapse in care, could cause millions for a sponsor in terms of credibility. Those who have remained engaged in clinical study management have seen repeatedly, how important it is to keep patient advocacy groups engaged every step of the way to accommodate patient voice in the key study design. Patient Advocacy groups play a pivotal role representing the patient populations with certain conditions and support both a study sponsor contributing to the success of the study as well as could play a role in design optimizations to ensure patient voice is heard to meet the needs. Found a great read on 'Understanding role ...