Clinical data management plays a key role in the set-up and conduct of a clinical trial. We provide tailored, efficient data management for clinical trials to capture your data to support insightful and effective data analysis ensuring you meet key milestones.
Our data management services are in line with industry standards and are CFR compliant. We collaborate closely with you to design study specific case report forms for the collection of data as well as creating and testing study databases ready for data entry, performing data validation and query resolution, ensuring quality control and transferring data. We also have the expertise to clean, transform and integrate external data sources.
Our services include:
Project Timeline/Budget Management
Database Design and Build
Data Check Design and Build (Paper and EDC)
Database/Data Check User Acceptance Testing
EDC Training Data Query Management
CDISC Standards Implementation (SDTM and ADaM)
Local, Central, and Corelab Data Handling/Management/Reconciliation
Medical Coding (MedDRA)
Data Management Documentation (Data Management Plan, Data Transfer Agreements, etc.)
Investigator Meeting Presentation/Support
Data Management Metrics/Reporting
Quality Management – With experience in GCP and ISO standards