Approach
Good Clinical Practice (GCP) is the accepted standard applied by the FDA but, unlike GMP or GLP, the agency will accept alternative practices and conduct for clinical trials if they comply with applicable statutes, regulations or both. The FDA generally will only accept foreign studies performed under an investigational new drug application (IND) or investigational device exemption (IDE) if they meet the same requirements of 21 CFR Part 312 or 21 CFR Part 812, respectively, that apply to U.S. studies conducted under an IND or IDE. The FDA will also accept a foreign clinical study not conducted under an IND only if the study conforms to the ethical principles contained in the Declaration of Helsinki as set out in 21 CFR 312.120(c)(4), incorporating the 1989 version of the Declaration, or with the laws and regulations of the country in which the research was conducted, whichever provides greater protection of the human subjects.
At SOLABS we provide knowledge of implementing GCP best practice in order to comply with both FDA and other regulations. SOLABS supports the transfer of information between GCP and GLP/cGMP platforms such that the benefit of any experience gained in each domain is not lost.