One platform can bring countless gains to clinical trial financial management

According to IQVIA’s Rajesh Patel, unified platforms change how sponsors, CROs and sites operate and collaborate across a clinical trial’s entire financial lifecycle. Credit: Konektus Photo/Shutterstock.com

The complex task of managing clinical trial finances is generally accepted as a cost of doing business in the pharmaceutical industry. But today, higher costs and ongoing pressures to shorten study timelines are pushing the industry to look for new, more streamlined approaches to clinical trial financial management.

A top challenge is the use of siloed financial systems across the various steps of a clinical trial. Not only do sponsor, contract research organisation (CRO), and site teams need to learn and use different technologies for budgeting, contracting and payments, but they also often need to manually re-enter data from one system to another. This can slow down payments and trials overall and lead to problems ranging from payment errors to site disengagement.

Now, with the evolution of cloud-based platforms and artificial intelligence (AI), these disparate systems can be consolidated into one platform with one set of data and fewer workflows. This unified platform can significantly ease clinical trial financial management, so payments and trials can be conducted faster and more smoothly.

A unified platform does more than streamline technology and data. It changes how sponsors, CROs and sites operate and collaborate across a clinical trial’s entire financial lifecycle.

At the budgeting stage, a unified platform that draws on global benchmarking cost data can supplement pricing factors like site location, procedures and disease prevalence with a view of past payments and performance. This can help sponsors and CROs accurately budget clinical trials and include fair-market pricing in contracts, which can simplify negotiations with sites and accelerate their onboarding.

Typically, after a budget is finalised, it’s manually re-entered into a separate payment system. This takes time and creates the potential for data-entry mistakes, but a unified platform keeps the budget in one place, and once a budget is accepted, a sponsor or CRO can immediately start applying invoices and payments against it.

This single source of financial truth is especially invaluable for sponsors and CROs that work with hundreds or thousands of sites annually. Their effort and overhead can be greatly reduced when finances for global trials can all be managed in a central location.

It doesn’t matter whether a site prefers to send invoices via email, upload them through software or trigger payments through an electronic data capture (EDC) system. A modern unified platform can be configured to each site’s preferences and process payments accordingly. When all finances are managed in one place, sites can use the platform to easily track the status of invoices, review payments and reconcile any payment issues.

Payment processes can be automated based on whatever rules are in place within a sponsor, CRO, site or country. For instance, sponsors may approve automatic payments up to a certain amount, say $10,000, but require approvals beyond that threshold. Some countries also have unique rules, such as that sponsors or CROs pay physicians directly. The right platform can adhere to these rules so payments can be made in a timely and compliant manner.

A trial’s budget and other financial data can be used to drive a layer of intelligence that can further simplify and accelerate future clinical trials.

Throughout the entire process, embedded artificial intelligence (AI) can enhance workflows to provide even greater time, effort and cost savings. For example, AI can automate budget setup by scanning protocols and contracts, as well as to validate and automatically process invoices while identifying any anomalies. It can also use insights from these activities to predict and forecast payments of future studies and the financial impact of future clinical trials.

A unified platform can greatly ease financial management across the duration of a clinical trial. However, one of the keys to realising this promise is having the right technology foundation.

Sponsors and CROs should make sure the platform they choose addresses the unique needs of their organisation and the sites they work with, and they should make sure the platform will adapt to their specific needs with an end goal of accelerating clinical trials.

Key considerations when evaluating unified platforms include:

Flexibility
Clinical trials have a lot of variation based on factors like the sponsor or CRO involved, geography, phase and site type. No single workflow can fit every trial. This is why a unified platform should be flexible enough to accommodate the diverse needs of global clinical trials and the unique operating models of every sponsor, CRO and site.

In particular, the platform should be easily configurable. This means the platform allows a sponsor or CRO to adapt rules, approvals, interfaces, workflows and data models to their needs or preferences. These changes should be simple to make – providing value to users as quickly as the business requires.

Integration
Connecting siloed systems is a top challenge for sponsors today. While a unified platform does break down financial silos in clinical trials by combining multiple systems into one environment, it still needs to talk to other tools and systems, such as ERP, EDC and CTMS.

To simplify integration, sponsors and CROs should use a platform built with an ‘API first’ approach. This enables the platform to be interoperable with the rest of the clinical trial ecosystem, pulling in and pushing out data from upstream and downstream data flows.

Innovation
A unified platform can use today’s biggest innovations in areas like AI to ease and accelerate financial management across a clinical trial. But what a unified platform provides out of the box should be just the start of the innovation it offers to sponsors, CROs and sites.

By using a software-as-a-service (SaaS)-based offering, sponsors and CROs can take advantage of continuous innovation as it is added to the unified platform. Multiple new releases of the platform every year, for instance, can introduce multiple new or improved features. This can continually enhance how clinical trial finances are managed and extend the life of this key investment.

A unified platform can substantially simplify financial management and accelerate clinical trials. But that doesn’t inherently make it an ‘easy’ button for managing all aspects of clinical trial finances.

Today, sponsors and CROs are increasingly considering bringing clinical trial payment activities in-house. A unified platform can take on some of the most challenging aspects of this work, including budgeting, calculating payments owed to sites and processing payments. But sponsors and CROs also must be able to manage a variety of often complex activities when bringing payments in-house, including ensuring their processes comply with country-specific processes and policies. By conducting a readiness assessment, sponsors and CROs can identify what aspects of clinical trial financial management they can most efficiently retain or outsource while realising the promise of a unified platform to optimise clinical trials.