By Nina Anderson, Associate Director Clinical Research, inSeption Group; Dawn Niccum, Executive Vice President, QA & Compliance, inSeption Group; Erin Rosenbaum, Clinical Auditor, inSeption Group; Caitlin Horbacewicz, Director Clinical Operations, inSeption Group; Raul P. Lima, Executive Vice President, Strategic Clinical Operations, inSeption Group; and Lori Buckenmyer, Executive Director, Clinical Operations & Project Management, inSeption Group
Biopharmaceutical sponsors have consistently faced challenges in clinical trials, including difficulties with patient recruitment and retention, maintaining a favorable risk profile, and the pressure to be the first to market their products. Nevertheless, with the growth and evolution of the industry, these challenges are further intensified by rising competition, the emergence of new or spinoff Contract Research Organizations (CROs) and vendors, diverse perspectives on technology utilization, and evolving patient expectations, among various other factors.
Among these challenges, risk mitigation appears to be the most straightforward approach: identifying risks and taking steps to minimize or eliminate them. However, the effectiveness of clinical trial risk mitigation largely relies on the knowledge and timing of information available to investigators.
Access this eBook to gain insight into how gathering real-time data analytics and running comprehensive gap analyses can improve trial efficiency and overcome study challenges, such as patient recruitment and retention, risk mitigation, and evolving patient expectations.