Maximizing startup efficiency when time is of the essence
By Kathryn E. Vinson, MS, CCRC
We’ve all gotten in a hurry for various reasons. The alarm fails to go off; the car won’t start. In our rush to get to work on time, drop off the dog at the groomer, or pick up the kids from school, we inevitably forget something. It’s just the way it is. For the most part, it’s not a big deal – the forgotten lunch box can be replaced with a cafeteria lunch, etc.
In clinical research we don’t have the luxury of being able to forget a minor detail. One lost detail is lost faith in a trial, lost faith in a site, or lost faith in a promising treatment.
In a world that is dominated by the novel coronavirus, seeing fast-tracked trials for vaccinations and treatments related to the virus is not surprising. Neither is the fact that studies are being put on hold or enrollment of new subjects paused until the trials can safely continue.
What do all of these circumstances mean for us in clinical research? It means that at some point down the road – it could be this week for a COVID-19 trial or next year for a hypertension trial – we need to be ready to start – and start fast.
Fortunately for both sponsors and our associated research sites, DZS has a rapid study start-up process in place for events just like these. As soon as a protocol is approved and in place (and even prior to approval in certain cases), our team of project managers, data managers, CRAs, and more are ready to get the trial “FPI-ready” quickly.
Just as every trial is unique, we know that every sponsor and every site is unique. We begin by meeting with all major players to identify and clarify all roles in the trial to avoid any misunderstandings. Through pre-planned meeting agendas, standardized template plans, checklists, and an experienced EDC Build team, our process can save weeks on the typical start-up time.
As we move forward, more collaboration means fine-tuning assumptions, revising definitions and documents to ensure that all data points are being accurately captured, monitored, and analyzed. A final go-live meeting is held once the database is ready and the site is approved to begin recruiting. Our Sponsor partners can rest assured that our extensive database of successful investigators can help meet their accrual goals in record time.
As clinical research professionals, we always are and always have been guided by the primary tenant of the protection of our volunteer participants. Regardless of the timeframe, safety is always of the utmost importance. While the world of clinical research has been thrown for a loop lately, here at DZS we remain committed to our promise to be your “Direct Line to Maximized Trial Efficiency.” With our Rapid Study Start-Up expertise, you can rest assured no detail will be overlooked.