Investigational new drug or investigational device exemption application support service

eagle-i ID

Resource Type

Properties

1. Fee for service

   Yes

2. Resource Description

   The CRSO IND/IDE Support Program guides and supports: • Investigators who are filing Food and Drug Administration (FDA) Investigational New Drug (IND) or Investigational Device Exemption (IDE) applications • Investigators who are serving as a sponsor or investigator for either single- or multi-site projects • Sponsors or investigators who are completing FDA-mandated submission materials and meeting subsequent reporting and documentation requirements The office also works with The Research Institute’s leadership personnel on issues of risk and feasibility. <i>email requests to hodgsonm@email.chop.edu with details for a fee quote</i>

3. Service Provided by

   Clinical Research Support Office (CHOP)

4. Website(s)

   http://www.research.chop.edu/programs/crso/services/

5. Related Technique

   Clinical trial technique