the IRCM IRB is expert in the creation of compliant study submissions that will meet FDA and HHS requirements

CONNECTING PHYSICIANS, RESEARCHERS, SCIENTISTS AND ACADEMICS

Doctor with health insurance healthcare graphic.

Regulatory

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.

Details of doctor hands typing on keyboard

IRB Submission Consulting

Submitting compliant studies to an Institutional Review Board can be daunting. Let our experts help you prepare a succesful study.



Creating Submissions

The process of writing out a full study, with protocol and informed consent, can sometimes be a daunting process for a physician or researchers. Having approved hundreds of studies for researchers and MDs across the country, the IRCM IRB is expert in the creation of compliant study submissions that will meet FDA and HHS requirements.



IRCM Consultation Service

The IRCM IRB submission consultation service includes the complete build out of the researcher’s study and informed consent, working with the researcher’s protocol to insure that it is compliant with the latest IRB, state and federal regulations. During consultations, all questions regarding the preparation of an IRB submission, national IRB policies, requirements for compliance, informed consents and dealing with unanticipated problems will be answered.



Consent Writing

An important element of a complete study is the Informed Consent which must be signed by all subjects prior to participating in any research. An Informed Consent is a part of the overall study which the IRCM IRB will prepare if engaged to create the study submission. However, the IRCM IRB can construct a clean, compliant IC for your study, as an a la carte 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.

The Institute of Regenerative and Cellular Medicine

100 Wilshire Blvd. Suite 700
Santa Monica, CA 90401
Phone: (888) 664-8893