A recent article in Applied Clinical Trials magazine made some interesting points regarding the clinical trial industry and its slow adoption of new technology. Compared to many industries, the clinical industry is more reluctant to embrace new technology available in the marketplace. Interestingly enough, this slow adoption rate is less about comfort in old technology and more about a risk-averse culture seen throughout the industry. As a result, many research organizations are wasting time and money monitoring every aspect of their clinical trials for fear of falling out of compliance with the FDA. With budgets being stretched thinner than ever, this practice has compounding effects on the overall profitability of clinical research organizations.
Rather than wasting time and money on monitoring every aspect of clinical trials, research organizations should be utilizing new technology to implement a risk-based monitoring system, which allows research organizations to target their monitoring to areas that are most likely to deliver the greatest benefits to the study while more effectively using the organization’s resources. A clinical trial management system (CTMS) software, like Clinical Conductor CTMS, is the premier example of how technology can allow research organizations to comply with regulations, while simultaneously optimizing how research organizations conduct clinical trials. Clinical Conductor gives research organizations the tools and the reports to effectively initiate a risk-based monitoring strategy. In addition, Clinical Conductor can also generate an ordered report documenting any adverse events. This way, research organizations can document and correctly report these events to the FDA.
The FDA is trying to eliminate the mindset that 100% monitoring is necessary for every clinical trial. The most important demonstration of this is the FDA’s commitment to encouraging research organizations to implement a system of risk-based monitoring. A large portion of FDA audits consist of analyzing adverse events, ensuring they were reported properly. Along with this, the FDA is more welcoming to innovative trial behavior such as adaptive trials. Ideally, this should reduce the stressful burdens on research organizations, which should lead to less errors and safer trials.
For research organizations looking to remain compliant while also increasing profitability, a proper CTMS like Clinical Conductor is the right choice to start efficiently monitoring trial risk while improving business operations. Clinical Conductor customers are given the tools to effectively manage every facet of their clinical trials along with unparalleled service and developmental support. Clinical Conductor is also continuously upgraded with user-focused features that help research organizations reach their true potential in clinical research.
To read the full text from the article published in Applied Clinical Trials, please click here.