Data Management

Biological sciences encompass an enormous variety of information, from the environmental sciences, which give us a view of how species live and interact in a world filled with natural phenomena to cell biology, which provides knowledge about the inner structure and function of the cell and beyond. All this information requires classification, organization, and management. Biological data exhibits many special characteristics that make the management of biological information a particularly challenging problem. All types of biological information and the modeling, storage, retrieval, and management of that information require special skills.

Our Data Management department is fully compliant with 21 CFR Part 11 and has the capability to deliver extensive clinical data management projects. Our team ensures successful high-quality data delivery by keeping your clinical development program on schedule throughout. Our team remains involved at every stage of data management and works closely with study sites to generate clean datasets with total quality. Our team comprises a data management executive, data entry operator, data manager, and medical coder along with internal data quality control executives.

Our data management team can manage multi-center, multi-country studies in both electronic and paper-based format. We are specialized in managing the following Data Management activities:

• Paper CRF/eCRF Development and Database Design
• Data Management Plan
• Data Entry, Verification, and Validation
• Double Data Entry (paper CRF)
• Coding in MedDRA and WHO DD
• Query Resolution and Database lock
• Design Safety Database
• SAE Reconciliation
• Electronic Data Integration
• Customized Data Listings