Since MEDIDATA’s early days, data management has always been part of our core business activities. We have kept pace with the rapid development of pharmaceutical research, and established a variety of procedures on which sponsors can rely for both paper-based and EDC-based data management. Likewise, our experienced data managers are used to work in compliance not only with our in-house, but also with sponsor SOPs (partly or entirely). Data managers and programmers are regularly trained on various topics (specific and general topics related to their work in data management or programming as well as sponsor-specific requirements).

Our services comprise:

Setup

• Data Management Plans, including annotated CRFs and data validation check descriptions
• Setup of data bases and data entry masks (for both paper-based and EDC trials)
• SAS-based programming of validation checks and listings

Processing of Data

• Data entry and verification
• Data validation and data query generation
• Medical review by in-house physicians
• Import, linking, and reconciliation of external data
• Coding of diseases, adverse events, and medications according to the latest standards (general and/or sponsor-specific standards)
• Data base audits

Preparation of Data

• Data base integrations
• Mapping of data bases to CDISC SDTM for submissions, or according to sponsor- specific needs
• Preparation of documentation necessary for submissions