Background
At the height of the global COVID-19 pandemic, vaccine developers were working against unprecedented pressure. Regulatory timelines were compressed, manufacturing schedules were unpredictable, and every day counted.
One client sought a research partner capable of not only managing a Phase I clinical trial for their novel COVID-19 vaccine, but doing so with the speed, structure, and precision required to advance to later-phase development without delay.
The goal was clear: secure ethics and regulatory approval, initiate sites, dose the first volunteer, and complete participant follow-up — all under an aggressive timeline that most CROs considered unattainable.
The Challenge
This trial required exceptional coordination. Regulatory authorities were adapting processes in real time, and protocol amendments were being requested even during the submission phase. The trial also involved stringent immunogenicity assessments, demanding seamless integration between laboratory timelines, data management, and clinical operations.
In short, success depended on agility without compromise — delivering rapid approvals and recruitment while maintaining full compliance and scientific integrity.
Micron’s Contribution
Micron approached the project as a rapid-deployment clinical study, aligning teams across regulatory affairs, project management, and clinical operations from day one.
Within six weeks, Micron prepared and submitted complete documentation to both the local Regulatory Authority (RA) and the relevant Ethics Committee. Following their review, the study received full approval within 12 additional weeks, including the incorporation of an amendment requested by the RA.
Two weeks later, the first volunteer was successfully dosed, marking the formal start of the clinical phase.
Recruitment then proceeded with remarkable efficiency. Within 11 weeks of the first dose, 130 participants had been screened, enrolled, and dosed — all while adhering to strict eligibility and safety monitoring criteria.
After 26 weeks of immunogenicity assessments, the clinical phase concluded with database lock achieved just four weeks after the last patient’s last visit — a testament to Micron’s tight operational control and real-time data oversight.
The Result
The trial met every milestone on schedule, despite operating under pandemic-related constraints that affected global research operations.
Micron’s transparency, cross-functional coordination, and proactive communication kept both the sponsor and regulatory stakeholders informed at every step. The client’s internal team described Micron as “an absolute outlier in proactive problem-solving and end-to-end accountability.”
Outcome and Impact
This project demonstrated Micron’s ability to move with exceptional speed while maintaining regulatory rigor — a rare combination during the early COVID-19 era. The study not only delivered high-quality Phase I safety and immunogenicity data but also laid the groundwork for the sponsor’s subsequent Phase II and III programmes.
By combining strategic foresight, clinical expertise, and agile execution, Micron helped ensure that innovation could advance at the pace global health demanded.
"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"
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