Clinical Data Management Servce

Service Details

DRL has an experienced Data Management team, which recognizes the importance of a smooth interface with CRAs, Project Managers, Clients and Investigational sites. We ensure that the clinical data to be submitted to regulatory authorities that complies with GCP standards.       SDRL offers Clinical Data Management services from Phase I (early clinical development) to late Phase IV clinical studies with proven expertise in supporting global clinical trials. Our mission is to deliver rapid study start up and streamlined workflow that improves data collection with real time access to the data, with reporting capabilities to provide visibility into the study.       We have defined metrics and turnaround times for each step of our processes from database build and entry to query resolution and QC. This allows us to efficiently manage our time and ensure that we provide you with accurate costs right at the commencement of any study, which minimizes change orders. CRF/ eCRF completion guidelines are prepared alongside the design of the CRF to ensure that site staff are very clear on how to complete the required pages. These can be incorporated into the document itself or can be a stand-alone document. Clinical Data Management Services include:Paper and Electronic Data Capture (EDC) studies Preparation of Data Management PlanCRF designing and AnnotationsDatabase design and Validation programmingUser Acceptance TestingScanning and Indexing (paper studies)Double Data entry (paper studies)Discrepancy management & Query ResolutionSAE ReconciliationIntegration with a client's existing systems & processesCDISC Compliant Data TransfersData extractsData base lock and Archiving of the study documentation with databaseDatabase freeze Team Experience      The Clinical Data Management team has work experience under various therapeutic areas like Oncology, Transplantation, Osteoarthritis, Respiratory diseases, Hypertension, Cardiology, Medical Device, Neuroscience and Vaccines .