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