Managing The Clinical Research Enterprise

Clinical and translational research institutes and cancer centers confront challenges that are distinct from those of pharmaceutical companies and contract research organizations. These centers contend with hundreds of trials at once in an environment where there are many other, often competing, concerns ranging from limited resources to meeting ever-changing regulatory requirements. Organizationally, some activities are conducted by a centralized clinical trials office while others are performed throughout diverse groups or departments.

Often, cross-communication between these islands of information can be limited, making it difficult to maintain information about the institution’s entire research portfolio. Simple questions about the number of ongoing trials, the current status of these trials, and the status of accruals are not easy to answer. Maintaining a grasp of the financial status of studies is equally challenging. Even when critical data is available, there are significant latencies. The consequences include sponsors not being properly invoiced and data being entered multiple times into multiple systems all of which can result in billing inaccuracies, loss of revenue, and potential issues with the Centers for Medicare and Medicaid Services (CMS) guideline compliance.