Support Services

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IND & IDE Support

Provides support to Sponsor-Investigators involved in the development and submission of IND/IDE applications to the FDA.

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CT Registration & Transparency

Provides support for submissions, sharing study documents and disclosing data sharing plans.

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Monitoring & Compliance Support

Provides local monitoring services for clinical studies, RISE Reviews, and educational presentations.

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GCP Toolbox

The Good Clinical Practice (GCP) Toolbox contains general guidance and study documentation tools.

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Educational Outreach

Educational presentations are available to enhance the knowledge and application of Good Research Practice (GRP) principles.

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Multicenter Guidance

Guidance and Formal Application to conduct a clinical trial under sponsor-investigator held IND/IDE at external sites.