50 sites – 7 days – 2 continents. A Retrospective.

Ambitious. This is the word I would use to describe the 50/7/2 experiment. goBalto collaborated with a global pharmaceutical company and leading clinical research organization (CRO) to initiate Fifty sites on a mock study in Seven days across Two continents using our web-based site initiation tool – Tracker. We collectively pushed the “envelope” intentionally, to see what insights we could garner. The results were enlightening and provided our team with a strong signal in where to steer our product. The study teams and management at the sponsor and CRO also learned much in this exercise. As did the sites; in fact 100% of the participants found value. So, while the targets of this experiment may not have all been hit, the test was a huge success!

After only an hour of live online training with the sponsor and CRO teams and the same with the sites – it was off to the races! The experiment proved positive to sponsor teams, CRO teams, and sites that study startup can go fast and easily. Even though all did not complete in a week, the experiment proved it IS possible to expect site initiation in 3 weeks. Here is what we saw.

• 50 sites were invited
• 30 sites replied and committed to participate in the project
• 21 sites started and completed the study
• 18 sites completed everything in 3 weeks
• 3 sites completed everything and were “initiated” in 7 days

Let’s explore 3 of the key benefits we observed from sponsors and sites using Tracker to get their studies started.

1) Accelerated Site Initiation

The study startup team managing most of the heavy lifting in this Field Test replied with a range of 25-50% reduction in time taken to get sites initiated. The reduced time was a result of reducing time it took to get sponsors and sites on the same page. Tracker provided alerts to stakeholders to continually move the process forward and eliminating time spent manually updating spreadsheets and tracking down emails to figure out what to do next. An investigative site user said:

“I liked that I never missed an alert via email.”

2) Easily identify and resolve bottlenecks

For two days there was staleness in something we were all observing in Tracker.  The Financial Disclosure Form was not moving forward in the process… it was as though there was a wall in the way. One of the study managers simply clicked on the primary status graph and within moments saw who was holding up the process (Let’s just say – it wasn’t the sites). The statement made by that person’s supervisor summarizes it all:

“…finding out what the problem was could have been weeks or longer or never without the clarity we had using Tracker.”

3) Motivates Sites

Within Tracker, a site can view its own performance compared to the rest of the sites (in an anonymous fashion). About day 3 or 4 into the trial a site called up the sponsor to inquire about their ranking. It was much lower than they had expected and the site coordinator wanted to know what they could do to get ahead. By the end of that week, the site had completed all SSU tasks and documents.  Oh yea, they were the first ones done too! Positive reinforcement for our positive reinforcement!

Closing Thoughts

We are still collecting surveys from some of the participants and still interviewing everyone involved so I suspect we will have some more to share in the coming weeks. End result for now: sponsor and CRO companies are both aware that there is a better way to manage work and get through the process of study startup. We are happy to have been a part of proving it to them and are even happier that they are considering Tracker for their future trials!!

And finally, THANK YOU to all who participated!

Most of the reasons for not blowing this up into a bigger project are because the project required the donation of time and resources from all participating companies.  None of the sites, or the CRO or the sponsor or goBalto were paid anything for this research. And even a phony study with phony documents requires real time and real people to make it work. Also a big “THANK YOU” to our friends at CenterWatch for their generous contribution of some educational materials for the participants in the Field Test!! And once again from me personally, and the rest of the goBalto team: we applaud your contribution and forward thinking mind set. Everyone’s contribution is testimony to the interest people in this industry have for not accepting the status quo. Thank you for helping us push on the status quo!

About the Author

Dan Manak is the Director of Business Development at goBalto and a graduate of the University of Wisconsin – Madison. After earning his bachelor of science degree in Molecular Biology he began his career in pharmaceuticals with Hoffman-La Roche, holding positions in sales, sales management, and training. He has worked in pharmaceuticals, health care, and clinical research for over 20 years with Fortune 100 companies as well as start-ups. For the past seven years he led a small clinical research service organization as the President and Director of Business Development. His expertise and passion exist specifically in the area of clinical study start-up, having worked on several hundred protocols and initiating close to a thousand investigative research sites. In his spare time, Dan is a volunteer EMT and martial artist/Instructor.

Tagged as: Clinical Research, CRO, mock study, Site Initiation, sponsor, study startup