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Regulatory consulting covers biomarker development and biomarker clearance strategies, Good Clinical Practice (GCP), Institutional Review Board (IRB) submissions, Presentation Coaching and FDA interaction relating to cancer and other biomarker development.
Good Clinical Practice (GCP)
Provided by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), an international group that maintains these standards. Governments then reference these standards for creating regulations for clinical trials. Clinical trials of medical devices are regulated by a separate international standard (ISO 14155).
GCP enforces strict ethical guidelines on clinical studies. Training, record keeping, facilities, computer hardware and computer software are subject must meet extremely high standards of documentation for the clinical protocol. These standards are enforced with regular inspections. In order to ensure scientific authenticity and proper documentation of clinical trials, the GCP requirements must be followed. This includes the protection of human rights for subjects and volunteers and assurance of the safety and efficacy of the new compounds.
Covered in the GCP guidelines are specific regulations governing how clinical trials are conducted, defining the roles and responsibilities of sponsors, research investigators, and monitors (clinical research associates).
PrecisionMed, Inc. provides consulting to help navigate these often complex regulatory requirements. We help organizations cut through the red tape so they can get back to doing important research. Contact us to discuss how we assist you.
Institutional Review Board (IRB)
Also known as an ‘independent ethics committee’ (IEC), ‘ethical review board’ (ERB), or ‘research ethics board’ (REB), an institutional review board (IRB), is a type of committee formally designated to review, approve, and monitor biomedical and behavioral research involving humans. In the United States, the IRB often conducts risk-benefit analyses to determine the efficacy of certain research programs. The IRB assures that appropriate protections and rights are in place for human participants in a research study.
The IRB reviews research protocols and related materials in order to protect human subjects from psychological or physical harm and to maximize the safety of these subjects. The U.S. Food and Drug Administration (FDA) and Department of Health and Human Services’ Office for Human Research Protections allow IRBs to require modifications in planned research prior to approval.
With over 20 years of experience, PrecisionMed, Inc. helps organizations work with the IRB to ensure that the entire process is conducted in an efficient and orderly manner in order to maintain the highest ethical standards while maintaining critical research timelines.