With all of the focus on patient centricity and patient-centered clinical trials, it’s easy for the focus on investigative sites to be lost. Prior to the patient-centricity movement, at least for a time, site engagement was the concept du jour in the industry with conferences, articles, and surveys exploring and expounding on the importance of enhancing site relationships. And while some still believe that “patient centricity starts and ends with the investigative site,”1 it seems that the needs of the sites only get cursory attention these days. Not to detract from the importance of patient centricity, but without engaged and efficiently operating sites, many of the patient-centric initiatives will fall short of expectations. As someone who obsesses about root cause analyses, I have naturally been thinking about the primary root causes for why we seem to have lost focus and interest in the sites and what we can do about it.

Besides being just plain hard, there are many challenges associated with trying to engage different types of sites, with numerous site personnel — all of whom have different levels of experience and different needs — across the globe. The easy path is to just give up and pray that sites will just willingly comply with increasingly complex protocols, multiple technologies, low reimbursement rates, poor payment cycle times, and more. But alas, as we all know, praying is not a strategy for success. Some 10 years ago, when the topic of site relationship management was in its prime, some forward-thinking sponsors were starting to see a payoff with their efforts.2 At that time, much of the emphasis was on strengthening the soft skills of the CRAs or key site-facing personnel. As greater investments have been made in technology over the past decade, the site engagement initiatives have shifted accordingly — so much so, in fact, that sites are now feeling smothered by all of the technology solutions.3 That’s not to say that there is no room for technology-oriented portals and tools to facilitate site communication and engagement, but these need to be balanced with other site support programs.

The concept of a SPOC, or single point of contact, for investigative sites to have 24/7/365 access to a resource (in a local language) for questions and support is one such approach being advocated by at least a few CROs/service providers.4,5 While the concept of customer care centers is not new, the application to the clinical trial environment seems unique. Such an approach addresses one of the most common complaints that I hear from research site personnel via focus groups and site needs assessment surveys: They need immediate access to a live and knowledgeable person to address or triage their requests. I eagerly await the news of case studies and insights from the groups that are implementing such programs.

As with all things in life, there are great lessons to be learned by looking outside of our industry for help. Enter the work of CX, or customer experience, experts. According to the business dictionary, customer experience is:
The entirety of the interactions a customer has with a company and its products. Understanding the customer experience is an integral part of customer relationship management. The overall experience reflects how the customer feels about the company and its offerings. Surveys, feedback forms and other data collection techniques help a company to determine the customer experience.6

Not only is customer experience a buzzword and growing phenomenon, there is actually a society for professionals working in this area (https://www.cxpa.org/about/aboutus). Furthermore, as an interesting aside, as of 2014 there is a Patient Experience Journal (PXJournal.org). Who knew??

A fascinating article from Harvard Business Review on the topic of customer service concluded, “Telling frontline reps to exceed customers’ expectations is apt to yield confusion, wasted time and effort, and costly giveaways. Telling them to ‘make it easy’ gives them a solid foundation for action.”7

The article goes on to say that some of the most common recurring complaints about service interactions include having to:

  • Contact the company repeatedly (or be transferred) to get an issue resolved
  • Repeat information
  • Switch from one service channel to another (for instance, needing to call after trying unsuccessfully to solve a problem through the website)

I’m sure you can all relate. The gist of the article is about finding ways to reduce this burden or effort on the part of the customer and to measure the effects with what the authors coined as a new metric, the Customer Effort Score (CES). This score assigns ratings from 1 to 5, with 5 representing very high effort for the customer to get their needs or concerns addressed.

So what does all of this have to do with site centricity and site engagement? Truth be told, I’m not sure that anyone in our industry really goes out of his or her way to “delight” or exceed the expectations of the sites, but one can always dream. At least helping to make things easy for the site seems to be a good place to start. What if sponsors, CROs, and vendors were all to create their own “Site Effort Scores,” or SES, and ask sites to rate them on whether they are low, medium, or high effort when it comes to the sites’ ability to communicate with them? Think along the lines of how easy it is to get a protocol eligibility question answered — how much effort is involved in troubleshooting an issue with an EDC system, or how readily the site can find the answer to an FAQ or download the latest copy of the protocol on the web portal. You get the idea.

The sheer act of asking for sites to provide feedback in and of itself is a great customer experience tactic. Certainly many in the industry are familiar with surveys related to site satisfaction and preferences (e.g., which are the “preferred sponsors or CROs” to work with); however, the results of these surveys may not be all that actionable. Finding a simple metric by which to evaluate the effort it takes for the site to interact with you could provide even more revealing insights. Anything less than a “moderately easy” score should be a wakeup call to start evaluating your site communication processes and approaches and begin looking for areas for improvement. Measuring progress over time would reinforce that you are on a path toward enhancing the customer (site) experience. While it is a long time in coming, it is really only a matter of time until the site customers’ needs and demands will transform the clinical trial industry, just like the patient experience has transformed healthcare. I, for one, can’t wait.

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  1. Morgan, C.To improve drug development, it’s time to rethink clinical trial site engagement.Med City News.March 5, 2017. Retrieved from: http://medcitynews.com/2017/03/improve-drug-development-time-rethink-clinical-trial-site-engagement/
  2. Harper, B.Good site and sponsor relationships pay off.Applied Clinical Trials.Jan. 1, 2008.Retrieved from: http://www.appliedclinicaltrialsonline.com/good-site-and-sponsor-relationships-pay
  3. Sites smothered by technology solutions.Centerwatch blog post, May 1, 2017. Reprinted from Volume 23, Issue 05, of The CenterWatch Monthly.Retrieved from:http://www.centerwatch.com/news-online/2016/05/01/sites-smothered-technology-solutions/
  4. Parexel’s Customer Services.Retrieved from:https://www.parexel.com/solutions/informatics/customer-care
  5. Shea, K.SPOC:The logical choice for supporting your investigative sites.September 2013.Retrieved from: https://www.slideshare.net/kfshea/ohsug-2013-integrationfgspochelpdesksheafinal24sep2013
  6. http://www.businessdictionary.com/definition/customer-experience.html
  7. Dixon, M., et al.Stop trying to delight your customers.Harvard Business Review.July-August 2010.Retrieved from: https://hbr.org/2010/07/stop-trying-to-delight-your-customers

About The Author:

Beth Harper is the president of Clinical Performance Partners, Inc., a clinical research consulting firm specializing in enrollment and site performance management. She has passionately pursued solutions for optimizing protocols, enhancing patient recruitment and retention, and improving sponsor and site relationships for over 30 years. Beth is an adjunct assistant professor at the George Washington University and has published and presented extensively in the areas of protocol optimization, study feasibility, site selection, patient recruitment, and sponsor-site relationship management. Beth is currently serving on the CISCRP Advisory Board as well as the Clinical Leader Editorial Advisory Board, among other industry volunteer activities.

Beth received her BS in occupational therapy from the University of Wisconsin and an MBA from the University of Texas.

She can be reached at 817-946-4782 or bharper@clinicalperformancepartners.com.

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