IRB

Novum’s Independent IRB is responsible for the initial and continuing review of Early Phase studies conducted at Novum sites, and also serves as a central IRB for all Clinical Trials managed at investigator sites by our Clinical Trial Management division. Established in 1992, the Novum Independent Institutional Review Board (NIIRB) is composed of professionals with varied backgrounds and a wide range of interests whose primary responsibility is to ensure that appropriate steps are taken to protect the rights and welfare of human subjects participating in research studies. For studies with special requirements, the Novum Independent IRB has access to advisory experts who can provide scientific and medical expertise via a large network of specialists.

Compliance – The NIIRB operates in compliance with guidelines provided by the Food and Drug Administration (FDA Parts 50 - “Protection of Human Subjects,” 56 - “Institutional Review Boards” and 812 - “Investigational Device Exemptions”), by the International Conference on Harmonisation guidance relating to Good Clinical Practice and by the Helsinki codes pertaining to ethical conduct of medical research.