Year after year at clinical research conferences, the same dissatisfaction can be heard from clinical investigative sites regarding sponsor clinical payments. Despite this, many sponsors continually struggle to make the clinical site payment process efficient, transparent, and timely. Be it the frequency, timeliness, or transparency of payment details, investigator site payments continues to be one of the pain points in clinical trial operations. Whether utilizing a CRO, functional service provider or in-house staff and capabilities, there are some practical strategies which, if implemented early on, can help streamline and improve sponsor-site relationships in the area of clinical site payments.
Engage Early – Engage sites prior to clinical trial agreement (CTA) execution regarding clinical payments. An example would be including required financial forms (W9/W8 forms, bank wiring information forms, etc.) as well as requesting site financial contact information at the time when regulatory packages are sent to selected sites. This will assure such items are not bottlenecks when payment time comes around and that issues are resolved quickly in case they do arise. Assure all required forms are received from sites prior to CTA execution and relate, in a centralized manner, this information to all parties involved in the administration of clinical site payments (i.e. In-house staff, CRO, functional service provider). This point applies to any information required by sites which would impact payments.
Automate and Centralize Information Where Possible – Whether utilizing in-house staff, a CRO partner, or a functional service provider, steps to automate the clinical payment process is crucial for improved payment cycle times. Where larger sponsors are capable of utilizing a functional service provider for clinical payments, small and mid-size sponsors may not have this option. Even so, simply automating and centralizing small pieces of the process via the purchase of isolated clinical payment systems/services or creating an in-house database can reduce clinical payment cycle times by weeks.
Customized Clinical Site Payment Approval Process – Take some time to review your internal clinical site payment approval process to see who may be reviewing payments/invoices that are simply not needed. Many times these approval processes have been in place for many years simply because no one has questioned them. Many sponsors have a one-size-fits-all approach to payment approval across the organization. It is important that clinical site payments have a customized review/approval process which reflects its unique needs. Improving one or more aspects of the clinical payment process can drastically improve how quickly sites receive payments, thus increasing site satisfaction with sponsors, which in turn benefits the sponsor and ultimately the patients. Some questions to ask regarding clinical payment/invoice approval processes are:
- What is the need for each approver? If the answer is not clear or you find redundancies, it may be worth questioning why such an approver is needed. There may be a valid reason such as signing authorities in place. However, many times simply asking this question will reveal potential areas for improvements in the process.
- What is the "opportunity cost" of the person reviewing the clinical site payment or invoice? There is a saying which states, "Don’t waste a dollar’s worth of time to make a penny’s worth decision". Depending on the payment/invoice amount, including multiple layers of very senior internal staff at the sponsor or CRO in the approval process could unnecessarily delay the process besides not being a very smart financial decision for the organization. Many sponsors have established clinical payment approvers by dollar amount levels and may be hesitant to revise this point. However, if relationships with investigative sites are to be improved, sponsors need to be willing to think outside the box and question all areas of the site payment process.
Provide Accurate Payment Details – Make sure that all payments going to sites are accompanied with accurate detailed information relating to the payment. One of sites’ biggest pet-peeves are after finally obtaining payment to not know what it is. Assure internal processes are in place with both in-house staff and CRO or functional service provider in order for sites to receive this information.
Implement Clinical Site Payment Surveys – Implement Optional Clinical Site Payment Surveys early in the trial to resolve any relevant issues early and again at the end of the study. Sponsor-site relationships can be greatly improved and even saved by implementing this one point.
Prioritize Funding – It is important to constantly monitor site payment funding to avoid unnecessary delays when payment is due or an invoice is received. This includes establishing processes and proper communication lines that monitor funding buckets both internally and with CRO partners (or functional service providers), and consequently taking the necessary measures to assure timely payments.
Clarify Clinical Trial Agreement (CTA) Language – Assure clinical payment language in CTAs is clear regarding:
- Frequency of Payments – Although at first glance this may seem obvious, much of miscommunication between sponsors and sites come from this one point.
- Contact Information – Assure sponsor/CRO financial contacts for payment questions and communication escalation processes are clear in CTA. Sites should always know and feel they are able to contact the sponsor directly for clinical payment issues if they have not been resolved by assigned CRO or functional service provider.