Consultation to facilitate research participation by reducing potential barriers to participation and making research opportunities more accessible
Archives: Offerings
Support for all submissions to the FDA for sponsor-investigated studies conducted under an investigational new device (IND) or investigational device exemption (IDE)
Expert consultation for researchers on FDA regulatory requirements and compliance for studies involving investigational drugs, devices, and biologics
Training required for sponsor investigators conducting studies under an investigational new drug (IND) or investigational device exemption (IDE) to ensure compliance with investigational research regulations
A protocol template for investigator-initiated clinical drug trials (not to be used with medical device or hematology-oncology trials)
Worksheets to facilitate the development, review, and oversight of new drugs, biologics, and devices that require regulatory approval prior to dissemination
A collection of resources that guide compliance with FDA regulations
Connect with epidemiologists, biostatisticians, data analysts, and data scientists across U-M to enhance your health research outcomes
Engage with data analysis experts to ensure rigor in your clinical and translational research
A detailed sample template for streamlining clinical trial statistical analysis