PERC provides third-party auditing or services customized to meet project-specific needs. Whether establishing a Data Safety Monitoring Board
or responding to an FDA data audit request, PERC delivers specialized assistance. PERC understands time constraints and has the know-how to get
your project up and running quickly and resources to complete any task within tight deadlines.
Experienced auditors/reviewers and auditing/reviewing teams
Customized SOPs
Auditors skilled in monitoring and regulatory compliance issues
Auditors and data reviewers trained to protocol-specific and disease-specific indications
A clinical trial/project manager to act as the liaison between all parties, including regulatory agencies
PERC customizes services for auditing/review needs:
Arrange DSMB and conduct meetings specific to the project’s therapeutic requirements
Produce and implement SOPs or DSMB rules of engagement meeting FDA requirements
Develop auditing plans meeting FDA concurrence
Deliver project reports
Manage DSMB third-party contracts and payments
Provide accurate, documented tracking of the project’s materials, e.g., auditing worksheets or data measurements
