Consulting

Clinical Trail

Regulatory Affairs

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In a world of constantly changing regulatory demands, and with the increasing complexity of clinical trials, CirQuest Labs offers key services for compliance with regulatory authorities.

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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

Lab Services