Data Management Support

 We support the planning and execution of clinical data management strategies in the clinical development of pharmaceutical products.
 We support clinical data quality control operations from the sponsor company's perspective when the sponsor company, which does not have an in-house data management function, conducts clinical trials through a contract research organization (CRO). We also provide planning and support when establishing an in-house data management system for the first time.
 Furthermore, we support the implementation of EDC systems and ePRO/eCOA systems from the perspective of computerized system validation.

 Conventional clinical data management mainly involves checking the data collected according to clinical trial protocols for errors. Many of these tasks were outsourced to CROs, which were so-called "throw-away" operations.
 However, as required by ICH E6 (R3) and other regulations, recent clinical trials must establish a quality management plan from the clinical trial planning stage based on the concept of Risk Based Quality Management (RBQM) and build in data quality. In accordance with this basic concept, the CRO is only an organization that conducts operations in accordance with the contract, and the sponsor company must supervise all operations, including those of the CRO. In other words, "throwing everything at the CRO" is no longer acceptable from a regulatory perspective.
 To respond to this trend, we participate as clinical data management experts on the sponsor side from the planning stage of clinical trials, providing advice on CRO selection and clinical trial protocols from a data management perspective, establishing appropriate risk-based data quality check processes, and assisting with sponsor Oversight. This enables quality management in line with the new era, and provides substantial benefits in terms of preventing rework, additional costs, and schedule delays due to the discovery of serious data errors at the clinical study summary report stage.