PANEL Choosing an outsourcing model: FSO vs FSP vs inhouse

  • Weighing up pros and cons of different outsourcing models: which is best for your trial?
  • When is mixing and matching better than fully outsourcing or keeping trials fully in house?
  • Developing an outsourcing strategy as a small to medium sized biotech with limited resources
  • Why is FSP becoming a popular choice among sponsor companies and how can this support meeting trial timelines?
  • How do strategic alliances impact this decision?

Remote study on a shoestring: lessons from an OTC clinical trial

  • Milli Expanding Vaginal Dilator’s Regulatory Arc: Wellness to Rx to OTC
  • Market told us robust clinical would support adoption—need to do fast and cheap
  • Developing the study protocol and clinical operations POMPOM – Milli
  • Recruitment strategies and metrics
  • Remote data collection and compensation
  • Baseline Data Abstract accepted by ISSWSH
  • What we learned
  • Future studies: lather-rinse-repeat