Accommodating Last-Minute Design Changes In Global Clinical Trials

In IRT design, as in life, timing is everything. System specifications shared during the requirements gathering phase are usually no problem for developers. But those same specifications, shared days before the study “go-live” date for a global trial conducted in multiple languages, present an enormous challenge. When one sponsor learned of last-minute changes to their IXRS required by regulators, the study team had little hope that they’d meet their announced study start date. Almac’s Clinical Technologies team, however, was determined to help the sponsor launch the study on time.