PERC supports industry, enabling them to abide by the laws and guidelines that govern the clinical research environment. PERC will meet your needs, from establishment of a Data Safety Monitoring Board (DSMB)/Clinical Event Committee (CEC), to an FDA data audit response, to IDE submission or safety surveillance. PERC’s regulatory team can assist you through the current web of regulations.

Regulatory Affairs services include:

• Implement And/Or Facilitate U.S. And EU Governmental Submissions And Correspondence Based On The Client’s Needs
• Arrange DSMB/CEC And Conduct Meetings Specific To The Project’s Therapeutic Requirements
• Produce And Implement SOPs Or DSMB Rules Of Engagement Thereby Meeting FDA Requirements
• Manage DSMB/CEC Third-Party Contracts And Payments
• Provide Accurate, Documented Tracking Of The Project’s Materials (e.g., Auditing Worksheets Or Data Measurements)
• Development Of Quality Assurance Plans, Unique To Trial Design