The IRCM IRB team of doctors and regulatory experts are highly knowledgeable about the FDA and HHS requirements for compliance in the field of human bio-medical research. All submissions for approval by investigators will be reviewed for compliance issues and applicants will be given advice on how best to meet regulatory issues.
For investigators who are just beginning the process of seeking the approval of an Institutional Review Board, the IRCM IRB also provides consulting services on the nature and direction of their research. This allows clients to prepare for regulatory challengers they can expect to meet, and how to navigate them.
Moving toward an IND
Many clients of the IRCM IRB have taken their research to publication, or to the next level in the process of developing a proprietary protocol with a clinical trial. This is the Investigational New Drug (IND) process, and the IRCM offers consulting in applying for IND. As it pertains to regenerative medicine, an Investigator IND is submitted to the FDA by the physician who initiates and conducts the investigation and can cover both the study of an unapproved drug/product/therapy or a new application for an approved drug/product/therapy.
IRB Submission Consulting
Submitting compliant studies to an Institutional Review Board can be daunting. Let our experts help you prepare a succesful study.
IRCM Consultation Service
Setting up a CRO
The IRCM IRB can assist clients in establishing a contract research organization which creates a company intending to support pharmaceutical, biotechnology, and medical device firms in the form of research services outsourced on a contract basis. As a niche researcher, you can engage sponsors as a specialty CRO.