Regulatory Compliance Simplified

The Practical Solutions Group, LLC partners were retained by a CRO to help with the client-specific customization of a new version of an EDC system. This activity is the responsibility of the CRO’s Data Management department in conjunction with the CRO’s Programming department.

After a site visit of four working days, which included a documentation review and interviews with the CRO’s data management, project management, programming and quality assurance personnel, the Practical Solutions Group, LLC partners recommended an unconventional but compliant way to test the system through documenting the existing CRO document management and testing processes. This minimizes the CRO’s testing effort of the EDC system customization by 4-6 weeks each time a new project is undertaken. The 4-6-week head start gives the CRO an advantage of launching any data management project faster than any of their competitors. This translates into $20,000-30,000 monetary savings (a conservative estimate) every time this CRO needs to customize the application to support a new project.

The unconventional system testing approach was reviewed by two of the CRO’s clients and found to be acceptable from the regulatory compliance perspective by both. Even regulatory compliance can be practical with assistance from The Practical Solutions Group, LLC.