The Hidden 21-Hour Bottleneck in Study Startup
Ask most people what slows down study startup, and you’ll hear the same answers every time: contracts, budgets, IRB review.
Rarely does anyone mention source preparation. Yet new joint research from the Tufts Center for the Study of Drug Development and CRIO found that for high-complexity studies, sites spend 21+ hours building source documents before a single patient can be screened.
In this episode of Scope of Things, Ken Getz (Tufts CSDD) and Rick Ward (CRIO) join guest host Deena Bernstein (Transformative Pharmaceutical Solutions) to unpack what that research uncovered, and why the industry has overlooked it for so long.
What you’ll hear:
- Why the belief that sponsors “can’t” share source documents with sites is, in Rick Ward’s words, an urban myth
- The real difference between EHR-to-EDC integration and what most sites actually need
- Why “final protocol” rarely means final, and what that costs sites downstream
- How the concept of site readiness expanded once researchers looked closely at source prep
- Where the easiest, highest-impact fixes are hiding in plain sight
“To build source for a more complex protocol is a more complex job.” – Rick Ward, Chief Commercial Officer, CRIO
Guest bios:
Kenneth Getz, Executive Director, Tufts Center for the Study of Drug Development
Ken Getz is a research professor at Tufts University School of Medicine and an internationally recognized expert on pharmaceutical R&D management, protocol design, and clinical technology adoption. He is also the founder of CISCRP and CenterWatch.
Rick Ward, Chief Commercial Officer, CRIO
Rick Ward leads commercial strategy at CRIO, drawing on experience at CluePoints, Greenphire, and Trifecta Clinical. He is a frequent speaker at SCOPE, DPharm, and the DIA Outsourcing Summit.
Deena Bernstein, Vice President of Business Development, Transformative Pharmaceutical Solutions (Guest Host)
Deena Bernstein brings more than 25 years of clinical research experience across site development, operations, and digital technology, including leadership roles at IQVIA and Datacubed Health.
Listen to the full episode to hear what changes when sponsors, CROs, and sites stop assuming source prep just happens on its own.