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
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.
The Result
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.
"The Micron team provided invaluable support for the setup and execution of our Phase I clinical trial. Micron is an absolute outlier in terms of proactive problem solving and end-to-end accountability. Micron has the highest recommendation for the rapid, agile and detail-orientated execution of this trial"
Project Manager
Phase IIb/c trial of a novel anti-tuberculosis oral regimen completed within one year
Recruitment of patients with tuberculosis can be challenging, and retaining participation of the full quota of 122 patients to assess response to treatment was crucial to the trial’s success.
Accelerating patient recruitment in a specialised anti-infective therapy area
Within the first month of Micron starting the study, monthly patient recruitment attained the target.