“My ECG reports take forever to come back from the Core Lab.”
“The eCRF won’t let me create a new subject.”
“This stupid machine is blinking an error code again.”
Sound familiar? Sprinkle in some colorful adjectives and it probably does -- these problems are common enough at clinical research sites. Equipment and systems have become increasingly technical and specialized, and study site staff has had to contend with more technology than ever before. And because of the proliferation of niche vendors who provide the new tech, sites have had to deal with more vendors than ever before, too.
And how are problems like these typically resolved? Someone at the study site works his/her way through a list of maybe 20 or more vendor contact numbers, places a call, navigates a series of menu options, and hopefully gets directed to someone who can help. And that assumes the site calls the right company; with tightly integrated systems, it’s not always obvious in which vendor’s system the problem lies. This is frustrating for sites. It takes time. It costs money (since “vendor wrangling” is seldom sufficiently covered in the budget). And it keeps study staff from doing what study staff does best – run the study, work with the study volunteers, and keep them safe.
Hint: It’s Not Training
Calm down. Of course, adequate training on equipment and systems is important. But training doesn’t solve every problem. Training doesn’t keep equipment from malfunctioning. Training doesn’t ensure vendors deliver what and when they’ve promised. Training can’t anticipate every situation nor address an unusual site circumstance. And training doesn’t turn people into infallible little machines; we make mistakes. And so, in all these cases, we’re back to site personnel interacting with perhaps scores of vendors, by phone or email, all over the world.
The Solution: a Single Point of Contact
Q: How do you help sites interact with dozens of vendors?
A: You don’t. You do it for them. Establish a single point of contact within the Sponsor* organization for a site to call when vendor issues arise.
Why is this a good idea when the expertise to resolve the issue lies with the vendor? Why is this a good idea when the introduction of a middleman may result in some inefficiencies?
Excellent questions. Here are our responses.
- Better Vendor Oversight. When sites filter their vendor issues through the Sponsor, the Sponsor can more easily track vendor performance. Are there vendors that provide low-quality solutions, are repeatedly late, or difficult to deal with? At best, these vendors are wasting time and money, and aren’t good for business (let alone site relations). At worst, these vendors are jeopardizing subject safety or study data integrity, and require immediate Sponsor intervention.
- Better Site Oversight. When sites filter their vendor issues through the Sponsor, the Sponsor can more easily track site performance. Are there sites that routinely use equipment and computer systems incorrectly? (Yes, now’s the time for that training.) Are there high-performing sites that are able to work independently? This information has always been important, but in an RBM paradigm, it’s essential. Adaptive monitoring plans rely on on-going site performance measurements so Sponsors can adjust resources accordingly. A reduction in monitoring visits means less opportunity to assess a site’s comfort level with study technology. The corollary of “if it ain’t broke, don’t fix it” is “if you don’t know it’s broke, you can’t fix it.”
- Ability to Identify Pervasive Problems. After the third or fourth site reports the same problem, it’s clear that this is not an isolated occurrence. Knowing that, the Sponsor can work with the vendor to resolve the problem before other sites experience the same troubles.
- Better Functioning Sites. We have a saying: “The Site Comes First™.” In our experience, all things being equal, Sponsors that put their sites first -- make things as easy as possible for the study coordinators -- get the best results. They also build the good relationships that keep the best sites coming back to work on future studies.
- Better Functioning Vendors. The efficiencies for the vendor here are clear. Who wouldn’t rather interact with a single point of contact than field individual calls from multiple study sites? Plus, with far fewer players, miscommunicating both problem descriptions and problem solutions is less likely to occur. The Sponsor contact and the vendor contacts will eventually settle into common terminology and build a history regarding past issues and resolutions.
What Do You Think?
We know that not everyone espouses this idea, and we recognize there are probably other effective processes out there. Sponsors, how do you help your sites deal with multiple vendors? Sites, do you have experiences and/or suggestions you can share? (Be kind, anonymize!)
*When we use the term “Sponsors” in this post, we’re including CROs that take on Vendor Management responsibilities on behalf of Sponsors.
Ms. Meehan is the Social Media Manager for Polaris Compliance Consultants, Inc. She writes the company blog and eNewsletter, manages the company website, interacts with clients and colleagues on social media platforms, and manages the company’s SOPs and internal training. Prior to joining Polaris in 2008, Ms. Meehan worked at a major telecommunication R&D company where she provided consulting and training on telecom services, and spoke at numerous industry forums. She holds a BA in Computer Science from La Salle University and an MS in Computer Science from Drexel University.