Case Study

Objectives

• The client wanted to rapidly initiate Phase I of their COVID vaccine trials.
• They needed a research partner with the experience and expertise to deliver the Phase I study, allowing progression to Phase 2

Contribution

• Following a confirmed proposal, we supported the client to rapidly develop submissions to regulatory authorities (RA) and relevant Ethics Committee in 6 weeks.
• Approval for the trial, including implementation of an amendment requested by the RA, was achieved in a further 12 weeks.
• First volunteer dosed 2 weeks following study approval.
• Recruitment of 130 participants completed within 11 weeks of first dose.
• 26 weeks required to measure immune response of the full study population.
• Database lock achieved within four weeks of last-patient, last-visit.

Conclusion

This complex Phase I COVID vaccine trial required rapid setup and agile delivery. Micron’s proactive problem-solving enabled the study to keep on schedule and generate data from 130 participants.