Liability demands putting sites at risk

Liability. Indemnification. Risk. These have emerged as the new four-letter words of clinical trials.

As sites increasingly are being asked to indemnify drug sponsors in order to participate in a clinical study, liability issues have moved to the forefront. Yet since most standard medical or professional liability insurance policies won’t cover these types of agreements, investigators could end up paying damages and costs from indemnification claims out of their own pockets.

For private, community-based investigative sites, indemnification has emerged as one of the most contentious issues in clinical trial contract negotiations. And since investigators already take on...

New recruitment tools abound, but results remain unclear

Patient recruitment—one of the most challenging and expensive aspects of the clinical research process—has undergone myriad changes over the years.

From trials moving overseas and advertising moving onto the Internet to CROs partnering with top-enrolling sites and using metrics to identify them, the recruiting landscape has been altered dramatically. And advances in mining electronic medical records to identify patients have added to these strategic and tactical shifts.But has any of them significantly improved patient enrollment and retention? Judging from...

Eye On Daiichi Sankyo

In its aim to address unmet medical needs, global pharma innovator Daiichi Sankyo plans to establish global top-level pipelines in its four core disease areas—thrombosis, diabetes, malignant neoplasm and autoimmune disease/ rheumatoid arthritis—by 2015...