By Lynn Fraser, Product Manager & Development, Bioclinica; Jeremiah Rehm, Clinical Solutions Specialist, Bioclinica
Activities once performed internally, such as trial design, data management, monitoring, site management, payments and clinical review oversight, today are outsourced to CROs and external providers from a wide geographic region. While outsourcing has brought expertise and cost reductions in a variety of areas, the practice has changed team composition, adding more layers of complexity in managing data and clinical trials themselves. Reporting, communications and data sharing and management present some of the greatest challenges. Inadequately addressed impacts may be felt in areas ranging from operations, to regulatory compliance.