How to Add a New Randomized Part to an Ongoing Study in Three Weeks
One of the world’s leading biotechnology companies was focusing on area of highly unmet medical need and developing a pipeline of medicines with breakaway potential to treat some of the toughest cancers.
The Sponsor had a longstanding relationship with Almac Clinical Technologies spanning more than two decades and when they learned from a regulatory agency that they would need to add a new part to the trial, they reached out for Almac’s support on how best to proceed.
This posed a question, when reconfiguring the existing IRT could delay the study for many weeks, could building a new IRT actually be quicker?
In this case study, read about Almac’s approach to rapidly accommodating protocol design configurations and data integration.