Clinical trials that get off to a good start are more likely to be successful trials. The study startup phase is where this happens, and includes such activities as; investigator selection, regulatory and ethics submissions, site training and ends with the site initiation visits.
Study startup is a time-consuming component of the clinical study that can be significantly delayed due to manual and heavily paper-based processes, requiring multiple approvals and hand-offs between the sponsor and the sites, as well as, between individual team members both at the site and within/between the sponsor – which makes this process a perfect candidate for optimization.
But what exactly happens in the study startup phase and how can it be improved? Through years of dialogue with sponsors, CROs and sites, we've identified 10 key steps that clinical trial sponsors take to select sites and activate them for a clinical study. Further, we've pinpointed where the study startup process fails and how to optimize each of these steps so you can gain competitive advantage in new drug development.
This eBook will take you step-by-step through study startup. The 10 steps are comprehensive and typical of the study startup process in the United States; however, you may find that the order of the steps vary from company-to-company and from study-to-study. Ideally, the protocol for a clinical trial is complete before site identification begins and study startup gets underway. The reality is that oftentimes the protocol is still being finalized as study startup kicks off. For simplicity, the 10 steps guide assumes a completed protocol.
Unless otherwise stated the term sponsor refers to the organization running the clinical trial, which encompasses Pharmaceutical/Biotech companies, CROs, AROs, and medical device companies.
Founder and President
"The process of conducting clinical trials is often long, complex, bureaucratic and, above all else, expensive. There has been a strong focus on study conduct and quality, but as stakeholders are increasingly aware that better study startup processes are linked to shorter clinical timelines, the emphasis has been shifting in that direction. Leading life science organizations are driving the adoption of this innovation by automating a cumbersome industry process, with the goal of getting medicines to those in need faster."
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