ICH E6 (R3) is coming at a time when life science organizations are still struggling to adopt ICH E6 (R2). There’s no question that ICH E6 (R3) will impact all organizations engaged in clinical trials. The intent of the forthcoming guidance is to drive efficiencies by enabling the use of modern business methods and technologies. But should organizations wait until these guidelines are ratified to realize the intended benefits? Read More

Clinical trials are the quintessential project, being both complex and requiring project management skills and techniques to bring them to a successful close. The measure of a project success — delivering on time and with quality inside the proposed budget — are key requirements in the highly competitive environment in which pharmaceutical and CRO organizations operate, yet this benchmark is seldom achieved. Read More

Bottlenecks can have punishing consequences on clinical trials and operational teams, forcing studies to get stuck in limbo when the delay lingers — and when bottlenecks become the norm, team members can grow frustrated and overloaded with a cascade of sudden tasks, potentially creating a resource and morale issue. Bottlenecks are particularly problematic for CROs as they can take a bite out of return on investment and raise oversight inquiries from sponsors. Sometimes, that stems from budget-busting overtime when teams move from idling into working long hours once the bottleneck breaks. Read More