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Clinical research organization (CRO) Beaufort has added quality oversight to its services for clients in the pharmaceutical , diagnostic, and medical device industries.
Beaufort has been engaged by a Top 20 Global Pharmaceutical Company to conduct quality oversight monitoring (QOM) visits for the company’s clinical trials.The partnership will help the company manage vendor quality and compliance during clinical trials in a uniform, quality-focused, efficient, and effective manner.
“The need for quality oversight monitoring continues to grow,” said John Wilson, Beaufort Senior Vice President of clinical operations. “Increased scrutiny and enforcement activity from the FDA and other regulatory agencies has heightened awareness among sponsors and CROs of the need to ensure the integrity of clinical research data.”
The Beaufort quality oversight team will provide the pharmaceutical company an understanding of how each of its studies is being conducted by the company’s other CROs. Beaufort will not audit the CROs, but will observe, critically assess and provide objective and unbiased feedback on the respective CRO clinical research associates’ level of knowledge, experience, and training for the specified trials. The company can then use those observations to provide feedback to the CRO.
Sponsors of clinical investigations, as well as CROs, have come under increased scrutiny recently from the Food and Drug Administration (FDA) for failing to ensure proper monitoring of clinical trials. The FDA holds sponsors ultimately responsible and accountable for the quality of work performed on their behalf. Recent FDA BIMO audits have cited numerous diagnostic, drug, and device companies for multiple issues such as:
-Failure to follow the protocol
-Failure to keep adequate and accurate records
-Problems with the informed consent form
-Failure to report adverse events
-Failure to account for the disposition of study drugs