Tuesday, February 2, 2016

Study Sites: Too Many Vendors, Too Little Time

By Laurie Meehan
IWRS Error

“I can’t get the IWRS to assign a kit number.”

“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.

So what’s the solution? 

Hint: It’s Not Training
GCP 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.”
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!)  Leave a comment here, visit our website, or send us an email.

*When we use the term “Sponsors” in this post, we’re including CROs that take on Vendor Management responsibilities on behalf of Sponsors.


  1. That's interesting and original idea! However as a voice of the site (study coordinator) I have to say I am skeptic. You say "with far fewer players, miscommunicating both problem descriptions and problem solutions is less likely to occur" - I see just opposite! For example. I call ECG vendor to get solution on ECG. I connect first with someone who gives me ticket number and and in few minutes I talk with ECG specialist who help me go through. I don't need additional player in that game! Even if there would be one "ticket person" for all vendors - how would be possible that in few minutes he would be able to connect me with the right specialist located randomly in the world?? ECG team works together to resolve my issue fast and accurately (let's leave aside reality). How all teams of all vendors in the world may be as efficient as one vendor for himself? I basically do not see organisation that would make it real. Could you explain that?

    1. Hi Hanna. Thanks for your comment. It sounds like you are working with a very responsive ECG vendor, and by all means, we encourage techniques that make things easier and quicker for the site. In some situations, going through the Sponsor would add to resolution time, but for many sites who are dealing with multiple vendors on the same study, they report that it would reduce time and frustration if they had one point of contact. And from the Sponsors' perspective, a single point of contact would help them achieve the vendor oversight they are required to perform. We are very happy to know that in some cases things are working very well! What we have been seeing lately though is many sites being overwhelmed with the management of all of the various “e-vendors".

    2. Dear Laurie, yes, I agree that number of vendors has risen up in last years and that costs sites both time and money. I hope your project will reduce that burden of work and help teams in studies management. Good luck!

  2. I agree 100% Laurie!

    So many sites are asked to use far far too many systems, even within a single trial. The sponsors think they are combining best of breed.... through a shopping list of different technologies that are required... is the best for their study.

    However. that becomes a multi-login, multi system query management nightmare for site staff. I am aware of some sites that have application software simply to help them remember all the passwords they need for each system for each study!! Just madness.

    Here is a list of things we did;

    1). Put all of the help requests, Q&A, tasks and data queries etc into the same place. It doesn't matter whether you are talking about signing an electronic consent form, responding to a query, or contacting the helpdesk for system a or b, everything goes through same same mechanism. Behind the scenes - all of the messages / requests can be routed to internally or to different vendors. To the sites - they have one system...

    2). A single place to go for all systems - all forms for all uses are in the same place. This covers ePRO, eCRF's, eLearning Libraries, Site questionnaires. PLUS access to the other vendor systems from the same login (for vendors that support single sign on).

    3). eLearning for all vendors in the same place, including online certificates that control access to vendor systems until training complete

    4). Common document library giving site staff access to materials across all vendors.

    We are passionate about simplifying technology that supports sites (and patients) during a clinical trial. We sit in front of, or act as a lite weight alternative to Medidata Rave, Oracle Inform, CRF Health ePRO, eRT ePRO, Covance Core Labs, Vitalograph Spirometry and other systems.

    Doug Bain

    1. Thanks, Doug, for your comments and for introducing us to ClinPal. I just spent some time on your website, and see you've assembled a very useful set of electronic services for trials. (Also, I noticed while reading "About You" that I wrote a blog post in 2014 featuring the work of one of the members of your Core Team. Here's the link if you'd like to read it. http://polarisconsultants.blogspot.com/2014/06/results-of-first-ever-remote-clinical.html.
      We're going to give you guys a follow on Twitter and see what else you come up with! We're @ConsultPolaris, BTW. See ya out there!

  3. Great post, I appreciate you and I would like to read your next post. Thanks for sharing this useful information regulatory compliance consulting firms

    1. Thanks! If you want to be notified of our blog posts (1 every 4 to 6 weeks), you can subscribe here: http://polarisconsultants.us4.list-manage.com/subscribe?u=ea8cc70abb2be3995546f1c73&id=5a72de7cd9