By Lisa R. Pitler, JD, MS, RN, CHRC, Managing Director, Regulatory Consulting
A key component to the success of a clinical trial is opening a site for recruitment, which requires accelerated startup times. Delays in budget negotiations and site startups can dramatically alter these timelines. From the sponsor’s perspective, managing budget negotiations at multiple sites is a monumental task, addressing numerous, often conflicting funding requests from sites. This blog explores the impact of budget negotiations on study startup from the perspectives of both sites and sponsors.