Rapid initiation and agile delivery of a complex Phase I COVID vaccine study

The Challenge

The client was seeking a research partner with the experience and expertise to deliver a Phase I study of their Covid vaccine. Regulatory approval of the trial, managed by the CRO, was required as part of a rapid initiation followed by efficient performance.

Micron's Contribution

Our Approach & Impact

Following a confirmed proposal, we supported the client to rapidly develop submissions to the local regulatory authority (RA) and the relevant Ethics Committee within 6 weeks.

Within another 12 weeks, the trial had been approved with the inclusion of an amendment that was requested by the RA. The first volunteer was dosed two weeks after study approval.

A total of 130 participants were recruited within 11 weeks of the first dose being administered, and 26 weeks were required to measure the immune response of the full study population. This successful trial was completed when the milestone of database lock was achieved just four weeks after last patient last visit, which marked the end of the clinical phase.