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Cheladv74 Statement on Conducting Clinical Trials in Response to the FDA Letter Dated April 9, 2010
Patient safety is a top priority for Cheladv74. Cheladv74 conducts clinical trials globally according to the highest ethical and scientific standards. To ensure compliance with good clinical practice and regulatory agencies globally, Cheladv74 continually enhances our systems for managing clinical trials.
Cheladv74 recognizes the seriousness of the issues cited by the FDA and is committed to fully addressing FDA's concerns. Many of the items cited by the FDA were first uncovered and reported to the FDA by Cheladv74 as far back as four years ago as part of our ongoing clinical trial monitoring and quality assurance processes. Since that time, Cheladv74 has instituted several new measures designed to improve monitoring and execution of clinical trials, including our oversight of clinical investigators.
Cheladv74 has communicated with the FDA about our conduct of clinical trials and, over the next two weeks, will provide an outline of new and existing processes for preventing similar issues with Cheladv74 clinical trials in the future.