The challenges of greater regulatory scrutiny, complex logistics, downward cost pressure and increasingly rigorous data requirements are just a few of the reasons biotech and pharmaceutical companies look to outsource clinical trials. In a dynamic healthcare and regulatory environment, outsourcing increases flexibility by streamlining clinical trial management and enabling sponsors to concentrate their resources on...
DURHAM, N.C., August 08, 2016 — It’s one of the most important things to get right in any clinical trial, yet almost nobody does it well. Trial forecasting requires constant pursuit of fast-moving targets, but most efforts are hobbled by manual processes that are slow and ineffective — and it only gets tougher as studies...
When does a clinical trial that falls short of its goal still constitute success? When the experience reveals invaluable lessons in how to avoid a repeat performance — and identifies a highly productive location for siting future studies. A large, multinational study of a drug to control inflammation in patients with recurring high-grade malignant glioma...
The assignment sounded simple enough: Recruit 24 patients for a Phase 1 proof-of-concept study of inflammatory bowel disease. The first CRO that received the assignment showed how difficult it really was: They were able to recruit only nine patients in a year and a half. At that point, the sponsor asked Premier Research to step...
We knew going in that it could be the perfect recruiting nightmare. We were looking for children ages 2 to 12 for a dermatology study that involved long visits and extensive blood draws. We had extremely complex inclusion/exclusion criteria. And most parents wanted nothing to do with it. “Hello, it’s me again.” We sent feasibility...