Future submissions of data for nonclinical studies must now comply with the FDA’s recently published SEND guideline (Standard for Exchange of Nonclinical Data). This complex reporting format has resulted in a multitude of questions and concerns from our customers planning GLP animal studies. Has your organization begun a dialogue with your CRO on how to implement or comply with these new guidelines?
KCAS began evaluating SEND software providers in 2015 to ensure we had the knowledge to advise our clients on their options and recommendations for studies requiring SEND format. Due to the complexity of the reporting criteria and KCAS’ proactive research, we were asked to participate in a SEND panel discussion at American College of Toxicology’s (ACT) annual meeting. Our participation was to provide insights on how bioanalytical labs fit into the SEND process. In this presentation, we share our perspective on the new guidelines and the questions we believe still remain.
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