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Regulations Relating to Clinical Trials

Here are links to regulations governing human subject protection and the conduct of clinical trials. USFDA: Electronic Records; Electronic Signatures (21 CFR Part 11)Regulatory Hearing Before the Food and Drug Administration (21 CFR Part 16)Protection of Human Subjects (Informed Consent) (21 CFR Part 50)Financial Disclosure by Clinical Investigators (21 CFR Part 54)Institutional Review Boards (21 […]

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Compliance of Clinical trial management system(CTMS)

The Clinical Trial Management System is the essential set of tools to effectively plan, manage and track your clinical study portfolio. It is a specialized, comprehensive project management application that takes the study team from startup, through enrollment and monitoring, to study close. Here are some important considerations for Compliance with a CTMS, including support

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