A customer faced with impending comparator shortage, complicated by expanding enrollment, partners with Almac’s Supply Chain Managers (SCM) to evaluate supply chain needs, assess potential risks, stretch supply and advise on global and regional clinical strategy.

When Almac Clinical Services was called in to address an impending product expiry, the sponsor’s situation with a Phase II clinical trial was quite precarious. The clinical trial was comparing the safety and efficacy of the sponsor’s Investigational Medicinal Product (IMP) to a comparator product at 74 sites across 13 countries. The comparator product was difficult to procure, and 100 percent of existing supplies were due to expire in 2 months.
Almac Clinical Services immediately set about estimating how much of the comparator product would be needed and how the limited supplies should effectively be distributed. The goal was to minimise interruption to the study by acting swiftly and on the basis of facts.

Thanks to Almac’s intervention, the sponsor’s clinical operations team’s fears were avoided. There was no need to halt enrolment. By carefully apportioning existing supplies according to Almac’s plan, the sponsor was able to continue the clinical trial uninterrupted; continuity that was important in preserving the sponsor’s relationships with sites and to keeping the development timeline on track avoiding additional costs and delays.

Click here to discover more about Almac Clinical Services