Direct-to-patient distribution (DTP) of clinical supplies is an increasingly important tool for sponsors to be able to support recruitment and participation in their clinical studies. This webinar will examine the results from a recent industry survey to evaluate just how important having a DTP option has become and sponsors understanding of the US regulatory requirements that must be satisfied in order to offer a DTP option. In addition, common DTP misperceptions, perceived challenges and potential benefits will be discussed along with a streamlined approach that bypasses the clinic entirely.
Topics to be discussed include:
- Sponsors perceived value of offering an DTP option including potential challenges and benefits
- Important regulatory considerations for DTP distribution in the US and Europe
- Review of DTP distribution models currently available to sponsors, including a streamlined, regulatory-compliant approach to bypass the clinical site
Nicole Gray, Director, Strategic Supply Solutions, Catalent Pharma Solutions