Donawa Lifescience Consulting: Data management

Compliant, flexible, cost effective: our high quality electronic data management services are tailored to specific sponsor requirements. The data management system is secure and managed by highly qualified personnel, who also provide expert service and support, all at an affordable cost. The system’s rapid study set-up makes it very cost-effective for small Phase I studies, while its power and speed allow the management of large studies involving thousands of patients.

The data management software platform provides the necessary audit trail, documentation and functionality required to comply with GCPs for computerized systems, and with US requirements for electronic records and signatures in accordance with 21 CFR Part 11.

DLC can provide the following data management services:

Development of a data management plan
Development of annotated CRF pages with data variable names
Set up of data structures
Double data entry
Edit checks programming
Serious adverse events and drug coding
Production and resolution of data clarification sheets

Quality Assurance:

In addition to the double data entry and edit checks, 10% of all data entered will be manually compared to the original CRF. If the error-rate meets DLC criterion, the data will be ready for database lock. If the error rate exceeds the DLC criterion, an additional 10% will be manually checked until a compliant result is achieved.

Please contact us for further information or assistance.

Regulatory References