An outside rescue expert can bring a fresh set of eyes to a troubled study and help you identify the true root causes of the failure. They can also find more cost-effective and efficient ways to implement some of the strategies you were planning to implement internally, resulting in a net savings.
The costs associated with missed milestones and timeline extensions are significant and can derail the trial entirely. Less than 10% of drug candidates reach approval, with sponsors often incurring the costs associated with failed clinical trials, or trials that are behind schedule. Playing the “blame-game” while a clinical trial fails will only slow down the rescue process and increase these costs. It is paramount that sponsors and CROs are proactively monitoring trial progress and working together to address issues as they arise.
Patient compliance was a serious concern, particularly regarding the reduction of sun exposure. Running a dermatology trial, especially in the middle of summer, can greatly affect patient compliance and the resulting, potential flare-ups in any dermatological condition.
Intelligent Project Management to the Rescue of a Scabies Generic Trial