When Biopharmaceutical companies select a vendor or a partner to manage or contribute to a clinical trial, it is absolutely critical that they do business with organizations they trust, who are competent, who understand their unique needs and have the capacity to identify long and short-term solutions. The company’s management needs to be sure all systems and processes for the conduct and management of their clinical trials would meet the expectations of the FDA and other regulatory bodies, so a capabilities audit should be conducted.
The assessment should cover at a minimum:
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Quality and utilization of Standard Operating Procedures for core activities
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Training of clinical trial personnel in sponsor-related SOP’s and documentation of such
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Experience of proposed staff to conduct and manage activities
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Records maintenance (essential documents, central clinical trial files etc)
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Quality Assurance and Quality Control Systems
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Data handling systems and processes
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Pre-marketing surveillance systems and processes
HCG has conducted comprehensive process and quality audits at hundreds of companies and research sites, recommending as well as developing and delivering solutions for identified gaps.
Pre-submission Audits
The data from pivotal trials are subject to FDA inspections as part of the NDA/BLA submission process. The sponsor should plan to ensure that BIMO inspections are not an impediment to approval of the product by FDA, and should plan a Quality Assurance process that supports this goal.
The management, monitoring and data quality obtained during the clinical trials by the internal or external team must meet the all international and local regulatory standards of quality and impeccable documentation to support the NDA/BLA submission with high quality outcomes. To do this, the audit trail should go straight to the data’s source, the clinical research site.