Institute of Regenerative and Cellular Medicine
A nonprofit institutional review board and research facilitation organization focused on ethical review and validation of investigator-initiated regenerative and cellular medicine studies. Provides IRB review and regulatory compliance services, pre-submission consulting and IND guidance, clinical-trial oversight for select indications, and tools for electronic submission and document storage. Also facilitates collaborative data aggregation, fiscal sponsorship for translational research, and introductions between clinicians and researchers.
Industries
N/A
Nr. of Employees
small (1-50)
Products
IRCM IRB Review Services
Institutional Review Board services specializing in human subjects research review, ethical oversight, and low-risk biomedical studies in regenerative medicine for independent physicians and researchers.
IRB Submission Consulting
Consulting service to help researchers prepare successful and compliant study submissions for an Institutional Review Board.
Regulatory Consulting
Expert compliance consulting services for FDA and HHS requirements in human biomedical research.
Physician Guidance
Individual attention and guidance through the application process to streamline review times and answer questions regarding IRB policies and requirements.
IRCM Consultation Service
Complete build out of the researcher's study and informed consent, ensuring compliance with latest IRB, state, and federal regulations.
Consent Writing
An a la carte service to construct a clean, compliant Informed Consent document for your research study.
IRCM IRB Review Services
Institutional Review Board services specializing in human subjects research review, ethical oversight, and low-risk biomedical studies in regenerative medicine for independent physicians and researchers.
IRB Submission Consulting
Consulting service to help researchers prepare successful and compliant study submissions for an Institutional Review Board.
Regulatory Consulting
Expert compliance consulting services for FDA and HHS requirements in human biomedical research.
Physician Guidance
Individual attention and guidance through the application process to streamline review times and answer questions regarding IRB policies and requirements.
IRCM Consultation Service
Complete build out of the researcher's study and informed consent, ensuring compliance with latest IRB, state, and federal regulations.
Consent Writing
An a la carte service to construct a clean, compliant Informed Consent document for your research study.
Services
Full board, expedited and exemption reviews of human-subject research with written determinations and ongoing continuing review.
Consulting to build compliant study submissions, write informed consents, and prepare supporting documents for IRB and regulatory review.
Advisory services to navigate FDA and HHS regulatory pathways and prepare for IND submissions.
Password-protected online portal for document upload, storage of protocols and SOPs, and tracking of application status.
IRB oversight and administrative support for trials addressing post-surgical wounds, high-impact trauma wounds, thermal and flash burns, and disc-related back pain.
Acts as fiscal sponsor to receive and channel charitable donations and grant funds for translational research initiatives and patient sponsorship.
Full board, expedited and exemption reviews of human-subject research with written determinations and ongoing continuing review.
Consulting to build compliant study submissions, write informed consents, and prepare supporting documents for IRB and regulatory review.
Advisory services to navigate FDA and HHS regulatory pathways and prepare for IND submissions.
Password-protected online portal for document upload, storage of protocols and SOPs, and tracking of application status.
IRB oversight and administrative support for trials addressing post-surgical wounds, high-impact trauma wounds, thermal and flash burns, and disc-related back pain.
Acts as fiscal sponsor to receive and channel charitable donations and grant funds for translational research initiatives and patient sponsorship.
Expertise Areas
- IRB oversight and human-subjects ethics review
- Regulatory compliance with FDA and HHS requirements
- Clinical trial submissions and IND preparation support
- Investigator-initiated translational research
Key Technologies
- Institutional review board review processes
- Regulatory submission support (IND/HHS/FDA guidance)
- Cloud-based client portals and electronic document management
- Electronic protocol repository (protocol vault)
News & Updates
Blog post linking to research on the Hippo pathway limiting retinal regeneration and potential strategies to stimulate Müller glial cell proliferation.
Article summarizing proposed state legislation requiring clinics to disclose when stem cell therapies are not FDA-approved.
Summary of a licensing deal between a university institute and a company to develop a potential stem cell therapy for Alzheimer’s disease.
Blog post linking to research on the Hippo pathway limiting retinal regeneration and potential strategies to stimulate Müller glial cell proliferation.
Article summarizing proposed state legislation requiring clinics to disclose when stem cell therapies are not FDA-approved.
Summary of a licensing deal between a university institute and a company to develop a potential stem cell therapy for Alzheimer’s disease.