Traditional approaches to payment management for clinical trials are highly manual, labor-intensive, and subject to human error. In an industry where timelines are critical and accuracy is paramount, sponsors seek a better way to negotiate, track and reconcile trial payments. Automation takes away the manual burden while offering new levels of speed and accuracy.
The clinical trial payment process represents a large burden for sponsors. A high number of manual processes usually fall to the project manager (PM) or clinical research associate (CRA).
The first stage is budget management. Sponsors must ensure they have the funds to pay for all necessary expenses and fees. Then, they must negotiate a payment agreement with each site. Once the trial is underway, sponsors must track all payments made to sites and vendors and reconcile them with the trial budget. By the end of the trial, all expenses must be accurate and accounted for.
But with automation a radical streamlining of the payment management process is enabled, from budget and agreement management to invoicing and payments. Tasks including visit tracking, payment calculation and invoice processing can all be automated. For example, using a cost template, a visit fee can be automatically generated as soon as the visit is complete. An automated system can also streamline task management, using in-system notifications to cut down on emails between teammates.
“We want to make sure that manual efforts are reduced,” says Daisy Zhu, head of global operations at digital technology solution provider Taimei. “An automated system can run by itself from end to end, from the very first source data to decide the payment, to the invoice, until we pay for it. Everything we do in the system is to help sponsors pay site payments faster.”
Today’s clinical trials landscape is characterised by a fast rate of change, increasing scale and complexity of trials. Meanwhile, large trials can involve more than 100 sites, meaning that numerous agreements and budgets need to be maintained. In an industry as highly regulated as clinical trials, accuracy and compliance are also paramount.
“Payment delays are the biggest pain point,” says Zhu. “If sites experience delayed payment, it can cause a huge problem.”
An automated system increases speed and removes the risk of human error, reducing the chance of delays or regulatory issues. Data coming from the trial’s electronic data capture (EDC) system can be integrated directly into the payment management system and used to verify fees and calculations.
“The only work that we need to do in the system is to make sure that we upload a correct version of the site budget,” Zhu explains. This frees up PMs and CRAs to work on more specialised, less tedious tasks.
Faster, more accurate and more streamlined payment management confers benefits to sponsors and sites alike. “If you pay with quick turnaround, it works as positive reinforcement,” says Zhu. “Sites will do better in the trial, and they will be willing to collaborate with this sponsor for other studies.” Sponsors can also enjoy cost savings by saving man hours spent on repetitive tasks.
As well as this, automation unlocks more advanced opportunities for sponsors. For example, a site cost database can capture all items paid to each site, and that data can be used for valuable bench-marking. “The reason why we build up this kind of database is that when they need to negotiate or do the budget for future studies, they can look to the database to have a more accurate budget for that particular site,” Zhu says. “And when they need to negotiate, they have better negotiating power because they have a benchmark of the site cost.”
Taimei’s Paylite enables all the invoice, task, visit, and payment tracking required for managing a clinical study. An integrated single source of truth, the EDC, enables the automatic verification of calculations.
Within any study, a sponsor can access the agreement and budget template for each site. They can track all visits through a visualized system which is automatically updated from the EDC, using different colors to indicate the status of the visit and its payment. The system makes it easy for sponsors to request invoices from sites and initiate payment. Workflows can be managed by setting up multiple approval processes, and colleagues will be automatically notified when they need to complete a task. Paylite also offers sponsors the flexibility to cope with different budget templates from site to site and across geographies.
Paylite’s data reporting and customizable dashboard make it easy for PMs, CRAs, finance teams and higher management to oversee and analyze a study. Visit analysis enables an accurate view of each visit cost. The site library can show historical data of invoices or paid items, automatically captured from invoices paid for sites.
When it comes to automation capabilities for clinical trial payment management, the sky is the limit. Taimei experts continue to work on new functionalities that will enable greater transparency, better bench-marking, and more streamlining than ever.