Why Sponsors Should Consider a Hybrid Approach for Clinical Trial Payments

"Investigator sites are overburdened with technology provided by sponsors to support clinical research activities. They often use different portals for entering clinical data, tracking payments and getting regulatory approval to see patients. This challenge is exacerbated when sites work with multiple sponsors that each have their own technology preferences."

The desire to have greater control over clinical trial payments and strengthen relationships with investigator sites is driving some trial sponsors to consider bringing these responsibilities in-house using a software-as-a-service solution. However, such SaaS solutions are not a panacea for the complexities and requirements of clinical trial payments. This is why a hybrid approach makes sense for many sponsors.

When sponsors bring clinical trial payments in-house, they take on the full scope of that work. Certainly, a SaaS solution will do some of the heavy lifting, such as crunching the data and calculating payments owed to sites. But sponsors also need to manage the various technical and compliance challenges of clinical trial payments, which can require them to obtain resources for administering site payments globally as well as following country-specific processes and policies.

With the right balance of insourced and outsourced payment activities, sponsors can receive all the benefits of a SaaS solution while minimizing the risks and burdens that come with managing global investigator site payments internally.

Key considerations when insourcing payments

The main appeal of a SaaS solution is its ability to quickly and accurately determine site payments.

The solution should be able to consume all patient-visit and related clinical data, apply the financial terms for each site’s clinical trial agreement (CTA), and accurately calculate payments. The solution should also have an intuitive interface for sites to upload invoices and supporting documentation for CTA items that require it, such as archiving and pharmacy fees. Financial information should also be easily viewable for both the site and the sponsor in real time.

By doing this using a SaaS solution internally, the sponsor can own more of that crucial site relationship. For instance, if a site has a question about a specific payment or needs support at any time, they can contact the sponsor instead of a third-party managing payments. In addition to strengthening site relationships, this can help sponsors advance sponsor-of-choice initiatives.

Investigator sites are overburdened with technology provided by sponsors to support clinical research activities. They often use different portals for entering clinical data, tracking payments and getting regulatory approval to see patients. This challenge is exacerbated when sites work with multiple sponsors that each have their own technology preferences.

This is why it’s crucial that sponsors prioritize the site experience when selecting a solution.

For instance, a platform should make information readily available and easy to understand. It should automate as much of the payment-related work as possible, such as uploading invoices, reconciling final payments and managing accruals.

For sponsors, it’s important to remember that a payment platform doesn’t operate in a vacuum. Its success depends on its ability to integrate with other systems, including clinical trial management systems, electronic data capture systems and financial systems. A SaaS solution that eases these connections, such as with API integration capabilities, can help sponsors save time and avoid headaches.

Where outsourcing makes sense

Sponsors shouldn’t wait until they bring payments in-house to understand how that change will impact staffing, internal processes and compliance or their associated costs. Instead, sponsors should conduct readiness assessments to identify these needs in advance.

A readiness assessment can reveal where a sponsor will need to revise roles. For example, they may need to adjust existing customer-facing positions to provide payment-related support to sites. Or they may need to create new roles to clean data so it can be processed by a payment system.

Understanding these impacts can help sponsors identify the payment responsibilities that may be too complex and costly for them to take on internally – and where outsourcing can be a lifesaver.

Facilitating payments across borders is a prime example of an activity that sponsors may want to outsource.

Countries around the world have unique requirements that must be met to successfully make investigator site payments. Some governments, for example, require that paying entities have a physical presence in their country. And in some cases, it can take several months to complete the work and secure the necessary regulatory approvals and bank relationships to meet just one country’s requirements.

Instead of putting this burden on their accounts payable departments, sponsors can give this work to a partner that already meets the requirements and has established banking relationships in the countries they need to pay into. This partner can do a final validation of payments and then handle all aspects of disbursing those site payments in each country.

Similarly, a trusted partner with global experience can help a sponsor use the optimal country-specific language that should be included in their global clinical trial agreement templates. This can help enable a smooth payment experience for both the sponsor and site, and support compliance with regulations that cover such things as research credits or value-added tax. The same partner can also help the sponsor comply with payment disclosure or “sunshine” laws in countries that have them.

All these areas where a third-party partner can offer support may not be immediately obvious to a sponsor. But when needs are identified through a readiness assessment, a partner can help sponsors avoid costly payment-related delays and disruptions.

A best-of-both-worlds approach

Even with the assistance of a third party, the transition to managing payments in-house won’t always happen overnight. Sponsors may benefit from phased or managed migrations.

This can be an opportunity for the sponsor to learn and get comfortable with the new processes required by their SaaS solution while they continue to outsource payment-related activities. During this transition, their third-party partner can play the role of a consultant, answering questions and helping the sponsor ease into their new processes as payments are brought in-house.

Regardless of what migration looks like, the sponsor can enjoy the best of both worlds using a hybrid approach to payments. They can expect rapid and accurate payments from their SaaS solution while strengthening their relationships with sites. And they can lean on the expertise and global reach of a strategic partner to address technical and compliance challenges while reducing risk and resource demands.

Jim DiCesare, Vice President, Financial Management Solutions, IQVIA Technologies, is passionate about delivering innovative cost benchmarking, CTA negotiation and site payment services that support clinical research conducted by sponsors and CROs. With more than 25 years of industry experience leading clinical operations teams at Merck, DrugDev, and now, IQVIA Technologies, Jim has expertise across the contracting, budgeting and investigator grant payment management continuum. He is a frequent speaker at industry conferences and has written for a variety of publications. He has a B.S. in Accounting from Kutztown University.

Why Sponsors Should Consider a Hybrid Approach for Clinical Trial Payments

Key considerations when insourcing payments

Where outsourcing makes sense

A best-of-both-worlds approach

Newsletter