By Débora S. Araujo
Have you ever heard the expression “the straw that broke the camel's back”? According to the dictionary, it refers to a seemingly small but yet the latest in a series of unpleasant events that makes one not want to tolerate a situation any longer.1 If there is any area to which this expression applies within clinical trials, it would be investigator site payments.
The ability of clinical study sponsors to make investigator site payments accurately, on time, and with the appropriate level of details has long been an industry pain point. Sixty-six percent of investigator sites report having less than three months’ operating cash on hand, with lengthy delays in site payments resulting in high turnover rates among clinical investigators.2 Luckily, innovations for both systems and services have been developed in the last few years to address this topic.
Unfortunately, with numerous choices, the classic “paralysis by analysis” creeps in when study sponsors get ready to explore engaging vendors to provide investigator site payment systems and services. Furthermore, even when a study sponsor moves forward and selects a site payment vendor, the relationship can at times be challenging because the right questions were not asked (and answered) during the vendor selection process. While the investigator site payment vendor implementation stage is also important, many of the hurdles encountered at that stage could have been avoided with a thorough selection process.
Knowing that the vendor selection stage for site payment vendors is critical, let’s explore just a few key questions to ask your potential site payment vendors prior to entering into a relationship for this very important site-facing function.
1. What is your site payment model?
Before beginning your journey to find the right site payment vendor partner, it is important to think about which site payment model will yield optimal results for your organization. Also, be sure to think about what goals you are looking to achieve (e.g., faster payments to sites, better relationships with investigator sites, relieving clinical teams from site payments responsibilities, becoming a sponsor of choice, more productivity, reduce site payment errors, etc.). While variations of the payment models listed below occur, these are currently the most widely used by study sponsors.
- In-House: In-house site payment staff and in-house systems (e.g., customized in-house system, Excel spreadsheet or similar program, site payment module within CTMS system, etc.)
- Fully Outsourced: Site payment vendor staff and site payment vendor technology are used
- Hybrid: A mixture of in-house staff and site payment vendor technology is used
2. Does the site payment vendor have capabilities and experience in different countries?
Confirm in which countries your potential site payment vendor has the capability for payments as well as where they already have experience. Specific country knowledge around currencies, local taxes, and customs is vital to ensure success. This question is not necessarily to eliminate any potential vendors that do not have capabilities in every country but rather to start an honest conversation regarding limitations early in the process. This will prevent unpleasant surprises later and allow for the development of mitigation plans if needed.
3. How easy are the site payment vendor’s systems and model to work with?
For both fully outsourced and hybrid models, it is important to have a potential end user involved early in the sourcing of the vendors and included in capability presentations. Your end user can serve as a subject matter expert who can point out potential challenges and generate solutions, saving you much frustration later on. Functional representatives for departments or teams that are directly or indirectly involved (e.g., finance) should also be involved in the selection process.
4. Can the site payment system handle studies with multiple arms?
For certain therapeutic areas, studies with multiple arms are quite common. It is imperative that the site payment vendor system or service can seamlessly accommodate studies with multiple arms. Any reputable site payment vendor system or service should be able to handle this need.
5. Can the site payment system manage studies with multiple payees?
While not as common within the U.S., studies conducted outside the U.S. frequently require multiple staff members within an investigator site to be paid separately for work conducted in a study. This needs to be configured correctly from the beginning in a site payment system and within the processes used. Any reputable site payment vendor system or service should be able to handle this need.
6. Can the site payment system deal with value-added tax (VAT) and other local taxes?
Although not much of an issue for investigator sites in the U.S., VAT and other local taxes may be something that a study sponsor needs to track for payments due to investigator sites in many other countries. The ability to include and track VAT and other local taxes is a must-have when selecting a site payment vendor.
7. Can the site payment system accommodate sub-studies?
These studies can be quite common for subsets of patients and require unique payment structures. Any reputable site payment vendor system or service should be able to handle this need.
Any clinical study sponsor that is serious about having investigator sites as partners and being a sponsor of choice must take an honest look at how they are handling this vital site-facing function. In order to ensure the viability of overall study performance and maintain strong relationships with investigator sites, site payments is no longer a function that can take a back seat or have less than stellar performance.
A full checklist of key things to include within your site payment vendor selection discussion can be accessed here.
This topic and similar ones will be discussed at the ClinBiz Summit 2020 taking place on March 24-26, 2020 at the Hyatt Regency in Morristown, New Jersey. Attendees can also attend the ClinBiz Summit 2020 remotely online via the livestream registration option. For more information and to register visit www.clinbizsummit.com.
- The last straw the straw that broke the camel's back definition and meaning: Collins English Dictionary. (n.d.). Retrieved February 24, 2020, from https://www.collinsdictionary.com/us/dictionary/english/the-last-straw
- Society for Clinical Research Sites (SCRS), Site Payment (White Paper), October 2016
About the Author:
Débora S. Araujo has over a decade of experience in the pharmaceutical industry working and consulting for Fortune 500 companies. Her special focus has been on the business aspects of clinical trials including: clinical contracting and financial management, clinical outsourcing and CRO/vendor management, global clinical trial budgeting and forecasting, clinical financial analytics and metrics/KPIs, site budget development and negotiations, fair market value, and global investigator site payments. Araujo’s passion for driving practical change in the industry led her to launch ClinBiz, an educational online platform where clinical trial professionals can stay connected and updated on the latest topics, trends and technologies related to the business aspects of clinical trials. ClinBiz also offers specialty consulting services.