Background
The sponsor of a first-in-human (FIH) monoclonal antibody (mAb) study faced a critical challenge. Their Phase I/II single ascending dose trial, designed to test a promising treatment for severe pneumonia caused by Staphylococcus aureus, had been suspended following organisational changes and the withdrawal of the previous CRO.
With sites inactive, study materials dispersed, and documentation incomplete, the sponsor needed a partner who could reassemble the trial infrastructure, re-engage investigators, and deliver enrollment targets under tight investor timelines.
The Challenge
This was not a conventional study start-up — it was a full-scale rescue operation. The trial had already enrolled ten participants under a previous sponsor, meaning data continuity, documentation reconciliation, and regulatory re-approvals all had to be managed without compromising compliance.
Delays risked not only the sponsor’s investment but also the momentum behind a therapy targeting a serious, hospital-acquired infection where new treatments were urgently needed.
Micron’s Intervention
In July 2014, Micron was contracted to take control of the transition. Within weeks, our project and regulatory teams coordinated the complex re-start of the trial across four countries and 29 investigator sites, working towards a total of 52 participants.
Our first task was to retrieve and validate the entire body of study materials and data from the former CRO and sponsor — from contracts to investigator binders to regulatory documentation. Once verified, we rapidly updated contracts with investigators and service providers, recreated missing Investigator Study File notebooks, and re-established the essential trial master documents required for compliance.
We then managed submissions to each country’s competent authority and ethics committee, navigating different national requirements to secure approvals efficiently. Meanwhile, our clinical operations team re-qualified all sites and organised two in-person investigator meetings and a global webinar to realign investigators, site coordinators, and labs under a unified operational plan.
By December 2014, approvals were in place. Within three weeks of regulatory sign-off, Micron over-labelled investigational product at each site, updated IWRS systems, and reactivated screening. The first new participant was randomised on 24 December — meeting the sponsor’s year-end milestone exactly as planned.
The Result
Enrollment targets were achieved by May 2016, closing the study successfully and meeting every regulatory and investor commitment.
This outcome was achieved not by accelerating blindly, but by managing the delicate process of transferring knowledge, documents, and data between sponsors, ensuring every site, regulator, and investigator remained aligned.
Outcome and Impact
Micron’s ability to manage complex, multi-country study transitions allowed this project to recover from near-stagnation and complete on schedule. The sponsor cited Micron’s responsiveness, structure, and hands-on management as key to turning a fragmented restart into a controlled, compliant success.
For studies caught between transitions, this project demonstrates Micron’s value: not only in operational recovery, but in safeguarding data integrity, timelines, and sponsor confidence.
Transforming Tuberculosis Treatment: A Breakthrough Phase IIb/c Trial
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.
Rapid Initiation and Agile Delivery: Phase I COVID-19 Vaccine Trial
This successful trial was completed when the milestone of database lock was achieved just four weeks after last patient last visit.