CirQuest’s regulatory capabilities include:
- Managing IRB/EC submissions
- Managing submission of study documents, protocol amendments, revised consent forms, updated investigator brochures, patient materials, etc.
- Maintaining regulatory documents
- Reporting of monitoring/site validation visits
- Assisting with Corrective/Preventive Action plans that may be associated with responding to FDA audits
- Providing preparation and planning for meeting with government and regulatory agencies