Data Handling CRO: Specialist Expertise
Data Handling, Clinical Data Management and Data Analysis
WILKINSON ASSOCIATES is a CRO which performs data handling using a fully validated, FDA 21 CFR Part 11 compliant, proprietary, SAS based clinical data management system, Clinfodata, containing all the features you would expect. We are not reliant on any external help desk to solve any problems that may occur, allowing smooth completion of every data management project.
Data Management Services
The following is a selection of the Contract Research Organisation services we provide:
CRF Design and Production
Database Design and Validation
Data Entry Screens
CRF Log and Tracking
Dual Data Entry and Verification
Programming and Validation of Electronic Validation Checks
Query Generation and Resolution
Electronic Audit Trail Generation
Adverse Event and Concomitant Medication Coding
Data Quality Reviews
Database Soft and Hard Locks
Database Status Updates
Even on large global trials, we can achieve database locks in less than 2 weeks of receipt of the last CRF.
Error rates for clinical databases are controlled and do not exceed 0.5% as an industry-wide standard. For critical data even zero errors based on a 100% review of data are obtainable. This is controlled and documented by database audits against the study CRFs.
FDA 21 CFR Part 11 compliance
Our data handling services are compliant with Good Clinical Practice (GCP) and are fully FDA 21 CFR Part 11 compliant, thus ensuring that the data from your clinical trials are managed to the highest standards. The Clinfodata system provides electronic audit trails with flexibility of reporting options. By continually enhancing and improving the system's functionality we can ensure that it meets our clients' current and future needs.
Our Standard Operating Procedures are regularly reviewed and updated in order to maintain consistent high quality, and ensure compliance with regulatory requirements.