Protecting Cash Flow: How Site Investigators and Staff Can Keep Site Payments on Track

Clinical Researcher—March 2019 (Volume 33, Issue 3)

SITE STRATEGIES

Shaun Williams, PMP

Clinical site payment technology is moving steadily toward automated systems and processes to help sites and sponsors/contract research organizations (CROs) track expenses, resolve invoices, and reconcile payments. Until such technology is perfected, standardized, and widely deployed, however, sites especially must contend with a number of payment-related issues.

Considering the “Payn” Points

Chief among the payment pain points for sites can be cash flow volatility. In its 2018 Site Landscape Survey, the Society for Clinical Research Sites (SCRS) found that 64% of responding sites had less than three months of operating cash on hand.{1} Similarly, the survey reported that more than 20% of sites made less than 5% net profit in 2017.

Payment delays cause financial hardships for research sites—so much so that the Clinical Trials Transformation Initiative (CTTI) found that as many as 40% of sites drop out of studies due to lengthy payment delays.{2} Taking a closer look, Forte surveyed 119 sites, and 21% of respondents cited “the invoicing process” as the driving reason for delayed payments.{3}

Many factors make sites’ invoicing difficult; for example, most small sites do not have dedicated financial staff, leaving invoice preparation and payment tracking to administrative or clinical personnel who are juggling many other duties. Trial logistics can pose billing challenges, as can the fact that investigators may operate out of multiple office locations. Further, sites frequently run multiple studies, each with its own unique invoicing demands; keeping up requires significant administrative organization and monitoring.

Streamlining the Invoicing Process

With approximately 50% of study budgets attributed to site payments,{4} sponsors and CROs are working toward standardization and automated solutions. In the meantime, sites can take the lead in making sure they are paid all that they are owed on time. More specifically, sites should:

• Negotiate an appropriate start-up payment. It is important to get off to a strong start on every study. By requesting funds up front and tied to a milestone achievement, such as a successful study initiation visit, you will best position your site to do just that. Be ready to justify your true costs as part of your negotiations.
• Ask for monthly payments as part of the contract negotiations. Although 77% of the respondents in the SCRS Site Landscape Survey preferred monthly payments, only 39% were contracted to that frequency.{1} The sponsor may insist on quarterly payments, but you will not know until you ask. In addition, by asking you will help raise sponsors’ appreciation of this issue.
• Study the payment section of the clinical trial agreement (CTA) closely. At the start of the trial, ask questions to be certain you understand the terms and effort required to manage the payment process start-to-finish. All sites, especially those outside the U.S., should also be clear on what costs are issued via a pro forma invoice.
  
• Be prepared to handle amendments. Amendments to the CTA, which are very common, should be negotiated as swiftly as possible, and all parties need to be clear on how the amendments will affect payments. Create and implement standard operating procedures specific to amendments and track amendment activities.
• Recognize that patient visits drive the majority of invoicing, but not all. On average, 30% of billable items include fees associated with non-study visit tasks, such as institutional review board (IRB) submissions and advertising.{5} Patient-related costs can often be triggered automatically from electronic data capture (EDC) systems, and sites should create a mechanism for flagging invoices for other events. Such triggers will help you secure faster payments for all billable study activities.
• Keep trial participants’ records up to date in the EDC system. EDC and remote monitoring enable sponsors/CROs to track individual clinical activities in real time. Depending on the study’s payment management system, that information may also trigger an automated payment once the predetermined, contract-specific milestone has been met.
• Collect billable activities data from the clinical team in the clinical trial management system (CTMS) and invoice only what has been approved within it. Your site’s or institution’s clinical and finance teams should meet regularly to review what is billable.
• Invoice often and on time. Build a simple tracker in Excel that lists all of the categories of billable work/items and the datapoints that will demonstrate that the activity has been completed. Such a tracker should be populated with data from the CTMS and with information from the detailed remittance notification that accompanies payments. Ask the sponsor/CRO if they can provide such a tracker for your use.
• Include all necessary details in your invoices. To ensure prompt processing, include all required details in every invoice. Included should be activity references, which will enable accurate and timely reconciliation of money received. Always list the account e-mail and contact telephone on the invoice, which will allow remittances to be set up automatically.
• Create an invoice template. Ask your sponsor/CRO for a template or create your own to streamline your ongoing payments management tasks.
• Establish a strong communication channel with the trial sponsor/CRO. At study start, identify the appropriate contact for all payment-related issues. Make sure you have a central contact for payment escalation.
• Use every tool you are given. If the sponsor/CRO has an established payments portal, register and use it. Being able to check payment status in real time—and on your schedule—will save you time and frustration while ensuring better cash flow.
• Follow up on delayed payments. Timely attention—and persistence—are keys to successful collection of late payments. Post reminders in your calendar and follow up every week until you see payment.
• Praise effective payments providers to your sponsor/CRO. Should you work with a payments provider that meets or exceeds your highest expectations, be sure to thank the sponsor/CRO managing the study. You might also recommend the vendor to other sponsors whose payments processes are not as well orchestrated.

Conclusion

The clinical development industry is well aware of the importance of developing payment solutions that work for investigators and their staff. Specialty payments firms and select CROs are developing technology and processes that will lessen site burden. Adopting the suggestions above, in parallel with the ongoing technology changes, will increase the benefits and satisfaction your site gains from conducting clinical trials—now and in the future.

References

1. Society for Clinical Research Sites. 2018. Site Landscape Survey. See overview at https://www.outsourcing-pharma.com/Article/2018/12/19/A-year-in-review-A-perspective-from-the-Society-for-Clinical-Research-Sites
2. Fassbender M. 2016. Payment tech automates reimbursements to clinical trial sites. Outsourcing-Pharma.com. https://www.outsourcing-pharma.com/Article/2016/07/20/Payment-tech-automates-reimbursements-to-clinical-trial-sites
3. Hrovat-Staedter A. 2017. Examining the impact and solutions to extremely delayed site payments from sponsors. Forte. https://forteresearch.com/news/infographic/examining-impact-solutions-extremely-delayed-site-payments-sponsors/
4. Ilancheran M. 2015. Investigator payments – channels, cycle time and benchmarks. Clinical Leader. https://www.clinicalleader.com/doc/investigator-payments-channels-cycle-time-and-benchmarks-0001
5. Lopienski K. 2017. How to speed up timelines for sponsor payments to research sites. Forte. https://forteresearch.com/news/speed-timelines-sponsor-payments-research-sites/

Shaun Williams, PMP, is Executive Director of Investigator Management Solutions for Syneos Health.