Data Management for Statutory Inspection Programs

Clinical data management plays a key role in the set-up and conduct of a clinical trial. As one of the largest biometric groups in Europe, we offer dedicated data management for clinical trials to capture your data in the best conditions, while meeting key and mandatory milestones.

Why Choose Data Management from SGS?

We can help you:

• Access Study Data Tabulation Model (SDTM) datasets shortly after the First Patient In (FPI) supporting your ongoing data evaluation at an early stage
• Ensure high-qualitative delivery of the SDTM database with our fully documented quality control of the SDTM mapping, including Pinnacle report
• Benefit from our in-house built SDTM library rules for data cleaning per therapeutic area or client
• Gain from our clinical research experience to pro-actively identify data cleaning risks, and bring tailored solutions
• Get timely, high-quality deliverables thanks to our comprehensive and streamlined cross-functional communication and established workflows with the other biometric departments

World-class Data Management for Clinical Trials

As a recognized leader in data management, our team is organized per therapeutic area/clinical study phase and can be dedicated to one sponsor. Our areas of service expertise include:

• Development of data management and data validation plans
• Set-up of the database according to our SDTM implementation guideline and/or sponsor requirements
• Validation of SDTM clinical database before cleaning of patient data
• Uploading and validation of external provider data
• Specification and validation of SDTM cleaning package
• Query handling
• Defining and handling protocol deviation
• Serious Adverse Event (SAE) reconciliation
• Coding of medical events (MedDRA) and medications (WHO Drug)

We have a separate team of data standards and process improvement coordinators and application developers who are dedicated to developing and maintaining in-house tools, data standards, dictionaries and programming applications. We constantly evaluate and improve our validated processes and guidelines to be on top of latest industry standards.

To discuss your data management requirements for your clinical trial, contact us today.