Clinical data handling by CRO (Contract Research Organization)

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

CRF Review

Dual Data Entry and Verification

Programming and Validation of Electronic Validation Checks

Query Generation and Resolution

Query Processing

Electronic Audit Trail Generation

Adverse Event and Concomitant Medication Coding

Data Quality Reviews

Database Soft and Hard Locks

Database Status Updates

Archival

Even on large global trials, we can achieve database locks in less than 2 weeks of receipt of the last CRF.

Error Rates

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.

SOPs

Our Standard Operating Procedures are regularly reviewed and updated in order to maintain consistent high quality, and ensure compliance with regulatory requirements.