RFI for Clinical Data Management Support Service

The Maryland-based government authority is seeking clinical data management support services to assist its clinical research program. The agency needs to solve the challenge of managing complex protocol data, utilizing both current and legacy databases, and maintaining strict quality assurance measures. The project covers gathering and entering protocol data, structuring protocol-specific data management processes, and performing specialized data management activities for transplant-related protocols. The selected provider must prepare data and reports for audits from regulatory agencies and sponsors, as well as deliver data management process overviews to new clinical teams. The agency requires an onshore organization based in the United States to perform all work offsite. The contract period will span one year, and the agency is currently looking for proposals to determine the budget. Bidders must submit their responses digitally via email or online. The agency has not specified detailed evaluation criteria or specific key dates in the initial request.