The regulatory team manages all regulatory aspects of the protocols for both industry-sponsored and investigator-initiated clinical trials and research studies.
The team provides fee-for-service activities including:
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Regulatory submissions (initial IRB application, continuing reviews, amendments, safety report forms, FDA IND/IDE submissions and reports)
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Developing study forms, such as Informed Consent (ICF), Assent, Parental Permission (PPF)
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Creating and maintaining regulatory documents to meet sponsor and federal requirements
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Ensuring compliance with ICH GCP E6 (R2), federal and state regulations, and institutional policies
Contact Us:
Phone: 801-587-7514