Leveraging technology to optimize the processes of budget build, budget negotiation, and payments

There is value to be gained in utilizing suitable technologies to support the financial processes of your study. Whether this would be for digitizing the budget build process, negotiating the budget with clinical sites via an online platform, or leveraging the re-use of data points to execute payments, the opportunities are vast. 

Efficient use of time and resources 

The events of the last year have restricted many of us to working from home, and subsequently, allowed us all to experience how technology can efficiently support us in our day-to-day activities. Moving forward, we should consider these learnings when assessing our organizational processes and technology landscape. When it comes to the financial aspects of study start-up and execution, manual Excel-based processes, and single, disconnected systems are still very much the norm.   

This way of working is time-consuming and ultimately affects the speed in which studies can start up, and the frequency at which sponsors are able to execute payments to clinical sites during execution. 

Budget building and negotiation – online platform 

The creation of the budget template usually occurs in an Excel format, and is shared with the clinical sites through email. This rigid process leaves much to desire both for the sponsor and for the clinical sites participating in the study. A digital solution to support budget building and negotiation between sponsor and site can potentially provide great value – not only in optimizing the negotiation process but also by creating transparency and establishing the opportunity for a long-lasting relationship for both sponsor and site. 

Re-use of data between processes 

The links between the budget build, budget negotiation, and clinical payment processes are often non-existent. By exploring and leveraging the technological opportunities in this space, sponsors can find value in the re-use of data throughout these different processes. The data points created in the budget build and negotiation process contain many of the same data points sponsors need and use as the foundation to execute payments to the clinical sites. By having a single platform, or several solutions with well-defined interfaces, the need for duplicative data entry diminishes.   

Adopting a risk-based approach to monitoring – with a positive impact on payments 

Two of the most commonly used payment triggers happen upon; 

  • receipt of invoice from the clinical site 
  • Source Data Verification (SDV) of EDC data at the clinical site by the monitor  

Both events are resource-intensive and far from automated in most cases, hence why this is a big factor in delaying payments to clinical sites. If we look closer at the second trigger listed above, it could be worth exploring how payment triggers could be redefined. Risk-Based Monitoring (RBM) is not a new concept, but nonetheless a concept that affects many parts of the organization if implemented. The speed at which clinical payments are executed relies heavily on EDC data – and whether sponsors trust the data entered by sites. With RBM in place, payments can be executed at a higher frequency by relying on a trust-based model – not the speed of SDV at sites. 

Ease of use – sites’ perspective 

There is great value for sites in having a platform available to conduct budget negotiation and follow the progress of clinical payments. Having multiple systems with multiple different log-ins is, however, not. Sponsors should therefore look to provide a unified platform making it easier for clinical sites to access via single sign-on and with easy overview of all financial information, where online help and e-learning is available, if needed. 

Do you get the most out of your budget build, negotiation, and payment processes currently? 

Whether your organization is looking to digitize the budget build process or potentially implement a platform for sites to negotiate the budget and track payments, HERAX can guide you throughout. 

At HERAX, we support our clients in optimizing their processes. We provide guidance throughout the exploration, assessment, and selection of vendors to deliver value-adding technologies supporting these processes.


Tobias Petersen
Senior Consultant

Tobias is a Pharma Business and IT Consultant. He supports clients across Europe within Clinical Development, Clinical Operations, and Regulatory Affairs. A Senior Consultant with an eye for detail, Tobias specializes in analyzing and optimizing processes, and development of quality documentation to support the implementation of processes and solutions. Having supported many projects across the clinical and regulatory landscape, specifically connected to EDC, CTMS, IxRS, eTMF, and RIMS, Tobias has a deep understanding of the operational processes these systems support. Tobias is able to combine this clinical experience with an insight into financial side, enabling him to have a solid foundation for understanding the challenges organizations are facing in the Clinical Payment space.