We provide structured clinical research data and document management services to support the systematic maintenance, tracking, and repossession of study-related data in both computerized and physical formats. Our services include management of Trial Master Files (TMF), Site Master Files (SMF), Investigational Product (IP) management documentation, regulatory and essential study documents, logs, forms, correspondence, and other study-related records. Our support covers the management of documents within electronic document management systems as well as hardcopy filing systems, with appropriate folder structures and document labelling. We assist with document collection, filing, updating, archiving, retrieval, completeness checks of documents. We can also support ongoing maintenance of study files to ensure that documentation remains current, traceable, accessible, and organized.
