A look back at the role of technology in clinical trials shows a succession of systems, each adopted to improve the speed, efficiency, and/or quality of the clinical development process while also reducing costs. Manual processes and paper-based record keeping were eclipsed by technologies such as clinical trial management systems and electronic data capture systems. These technologies made the clinical trials process more automated, (sometimes) faster, and (sometimes) less expensive.
Quality, patient safety, speed, and cost remain top concerns for pharmaceutical companies, medical device companies, and contract research organizations (CROs). Sponsors are under increasing pressure to reduce costs while also shoring up drug portfolios that have been eroded by patent expirations. CROs, likewise, face pressure from sponsors to reduce costs, yet also move drug candidates safely through trials more quickly. With an eye on speed, safety, and efficiency, CROs and sponsors are employing software that offer enhanced capabilities for identifying risks in clinical trials. The broad category of such systems is often referred to as risk based monitoring (RBM) technology. But even though such systems introduce new monitoring capabilities, too many fall short of delivering the full benefits of RBM. These shortcomings could represent an incomplete understanding of what RBM means and/or the failure of technology vendors to provide a comprehensive solution that embraces all of what RBM can bring to clinical trials.