In the intensely competitive clinical trial environment, the ability of sponsors to pay research sites consistently and transparently is a growing concern. Traditional methods are not meeting expectations, especially as payments have become increasingly complex due to the evolution of trial models, economic conditions and global challenges. Sites and sponsors need an efficient way to streamline the trial payment process and ensure investigators receive accurate and timely compensation.
Confronting Trial Site Payment Challenges
The issue of site payments in clinical trials is marked by several factors that have been aggravated in recent years, causing compelling challenges that need an innovative solution. These challenges include:
- Increased Competition Among Sites: A 2023 Bain and Company report shows 53% of sites surveyed reported having insufficient bandwidth to run trials. This statistic is a sharp increase compared with pre-COVID-19 levels of 15% and 47% at the pandemic’s peak. Competition for trial sites is fierce, and high rates of inflation and attrition lead to financial inconsistencies and confusion in many areas. The existence of legacy payment solutions and decentralized trial models force many sites to make tough trade-offs and turn down trial opportunities.
- Geographic Complexity: Conducting trials across diverse physical locations compounds the geographic challenge, as a Tufts Center for the Study of Drug Development 2023 impact report cites a 39% rise in the mean number of countries per Phase III clinical trial, and 41% and 25% increases in investigative sites for Phase II and Phase III trials, respectively. This expansion in geographic reach introduces logistical hurdles, regulatory variations and cultural differences researchers must navigate. The need to comply with different legal frameworks and manage multiple currencies adds complexity, leading to inconsistencies and confusion.
- Evolving Environmental Factors: The continuously evolving clinical trial environment introduces additional complexities to site payments. Elements such as direct-to-patient trials and splitting payments between sites and decentralized clinical trials (DCT) vendors have made trial protocols increasingly intricate. These changes necessitate new payment structures and coordination, often leading to incorrect payments and hampering internal and site reporting capabilities.
- Concerning Economic Conditions: Difficult economic conditions prompt sites to request additional budget items, impacting site payment schedules and cash flow for CROs and sponsors. Legacy payment solutions are faltering, as they were not built to address these diverse site payment challenges, and the decentralized trial model leads to further inconsistencies. These factors burden study team members with administrative tasks and necessitate careful navigation.
- Global Challenges: Dynamic economic and political landscapes across countries outside of the U.S. also introduce significant payment challenges. Regions like Canada, EMEA, APAC and LATAM represent complex scenarios involving multiple payees, variable payment distribution and performance-based payments. Inconsistent levels of economic development and legal systems lead to potential fraud and currency control complications. Fluctuating domestic affairs, political and social unrest and governmental structural shifts directly impact site relationships and payment capabilities.
To mitigate these challenges, sponsors must streamline payment processes, enhance transparency, and enable accurate and timely compensation. Features like the systematic alignment of protocol structure, data reconciliation, and automation are vital.
Reimagining Site Payment Handling
Reimagining site payment methods is vital to meet the demands of accuracy, efficiency and transparency. Integrating a clinical trial payment solution that leverages technology and innovative approaches would:
1. Increase Payment Efficiency
A tech-enabled clinical trial payment solution would ensure accurate, timely compensation by systematically aligning protocol structure with payable visit triggers. This alignment, coupled with features like EDC import, data reconciliation and payment calculation, would streamline processes and increase efficiencies.
Automation would be further improved through an Extract-Transform-Load (ETL) approach, allowing for a seamless payment experience. Sponsors would benefit from on-demand access to comprehensive payment information, detailed reports by country and payee and currency-improved transparency.
Payment notifications would keep site invoice recipients informed and engaged, while global portfolio visibility and robust forecasting capabilities support strong financial management and foster a transparent, efficient payment process.
2. Provide Complete Oversight
A tech-enabled clinical trial payments solution would offer comprehensive payment oversight and expert management of amendments, budgets and contracting. With user-friendly payment portals, sites would gain 24/7 access to complete payment information, promoting increased visibility and accountability.
The integration of critical clinical data from EDC systems, study budgets, agreements and schedules of events would enable automated invoicing for streamlined efficiency. Site invoice recipients would receive Pro Forma notifications when payable visit activity occurs and would get notified promptly in their preferred language when payments were released.
3. Enable Just-in-Time Funding
One of the standout features of a tech-enabled payment solution is the provision for Just-in-Time (JIT) funding. This approach would allow online approvals for JIT funding, exceptions, milestones, and more, streamlining the payment process. By integrating JIT funding into the payment system, sponsors and sites could ensure funds were available precisely when needed, enhancing efficiency and reducing the administrative burden.
4. Enhance Global Portfolio Visibility
A tech-enabled payment service would deliver a comprehensive view of the payment portfolio. Key features such as real-time dashboards would display individual and total payments by country and currency, and advanced forecasting tools would provide better financial management and could cut payment cycle times in half and significantly increase site satisfaction and cash flow. With the ability to handle payments in multiple countries and integration with other systems, such a solution would ensure a seamless payment process, regardless of the geographic diversity of trial sites.
Achieving Better Management of Clinical Trial Payments
The challenges of site payments in clinical trials are multifaceted, but integrating tech-enabled solutions offers a promising pathway to address these complexities. By consolidating payments through innovative methods, sponsors can enhance oversight and efficiency, aligning with the unique demands of modern clinical trials. This approach would streamline the payment process and build a collaborative, transparent relationship between all stakeholders, improving oversight and efficiencies through site payment consolidation.
About the author
Jim DiCesare is passionate about delivering innovative site activation and site payment services to clinical trials. With over 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. Jim earned a B.S. in Accounting from Kutztown University.
