Staff at clinical trial sites can “take it to the next level” by more effectively preparing for a sponsor’s pre-study visit, says clinical research consultant Elizabeth Weeks-Rowe, LVN, CCRA. In essence, it’s a job interview, and should be afforded the same time and attention smart job applicants devote when pursuing new employment opportunities.
While the vast majority of sites already do a good job in their preparation, Weeks-Rowe says there’s almost always room for improvement. It’s not an ironclad rule, but she’s often found that the way site personnel perform during the pre-study visit is a pretty good predictor for their actual study performance.
For example, site leaders should ensure that the right staff are accessible during the sponsor visit. In addition, the person leading the tour should either be able to field most questions on the fly, or have a clear understanding of who to reach out to onsite to get quick answers. Weeks-Rowe said she’ll sometimes ask five questions of her guide, only to find they can’t answer four of them. “It’s not a deal-breaker, but it’s not inspiring, either,” she says.
Sponsors often focus questions in three areas during pre-study meetings:
- Budget process
- Enrollment numbers
- How long it takes for an institutional review board to approve the site
For more information on this topic, attend Weeks-Rowe’s presentation on “Preparing for Site Qualification Visits: Critical Steps” at ACRP 2018, being held April 27–30 at the Gaylord National Resort & Convention Center just outside Washington, D.C. in National Harbor, Md. View Session Details
Getting this done right is likely to become more important in the future, Weeks-Rowe said. Pre-study visits are becoming more complicated and demanding, she added. In many cases, the visits have grown from two-hour meetings into three- or four-hour affairs with deeper dives into such areas as a site’s patient recruitment track record.
Additionally, so-called “soft skills”—such as presentation ability and easy interaction with a potential client—are important arrows in a site’s new business–pitching quiver, Weeks-Rowe said. A well-trained, skilled presenter can provide visitors with solid case studies and specific lessons learned in previous studies, and this can impress sponsors.
Author: Michael Causey