Regulatory Submissions, Information, and Document Management Forum

More often than not, sponsors are working with CROs to execute programs, trials, or functional tasks. This session will bring varied scenarios of CRO responsibilities and technology interaction. Data and documentation at clinical sites has long been a collection of paper, electronic, and portable digital mediums. Ensuring the completeness and quality of the site records has traditionally involved on-site monitoring model, but the size, complexity, and number of clinical trials mean that complete on-site monitoring is becoming an ineffective, expensive, and inefficient process. Alternate methods for remote monitoring will be explored. In addition, how can essential document management be utilized to enable CRO accountability and what are the best options to ensure compliance? Is there a benefit to both a sponsor and a CRO maintaining separate eTMFs? Is it too much of a good thing? What are industry and compliance driven best practices for a dual system model.