Conducting clinical trials on time ensures that innovative treatments can reach patients in need. In the face of logistical challenges caused by the Covid-19 pandemic, the clinical trial sector has faced major pressure to come up with innovative solutions to streamline processes and continue running trials. One such solution is robotic process automation (RPA), which is set to transform clinical trial management in the future.
The clinical trial sector is highly compliance-driven, involving vast amounts of data. The data from trials lay the important regulatory groundwork required to drive better health outcomes for patients by bringing innovative treatments to market, while also mitigating risks.
With the logistical disruptions posed by the Covid-19 pandemic, pharmaceutical companies and clinical research organizations (CROs) have turned to digitized solutions for collecting, managing, and analyzing trial data.
Today, CROs are adopting different approaches for remote data collection, such as smart sensors or wearable devices. Electronic health records and trial-specific electronic data capture systems are in use to ease data management. Even for data monitoring and review, remote and digital methods have been trialed, however, with mixed success so far.
Robotic process automation: a solution to automate structured business processes
Robotic process automation, a configurable software tool that uses rules to automate manual and repeatable tasks, is one such potential digital solution that has received a lot of attention in the clinical trial world.
“Robotic process automation undertakes standardized, high-volume tasks and conducts them efficiently in an error-free manner. While doing so, it builds quality control and compliance into the processes, cutting costs by 35 to 70%,” explained Doug Shannon, RPA Technology Lead at PSI CRO, a Swiss CRO.
In the past, automation platforms used heavy programming code to repeat processes, which meant that fixing issues or even auditing an automated process became highly tedious.
Today, automation platforms use robotic process automation instead, which leverages a much lighter code, enabling better end-user control with fewer complications. It also incorporates daily notifications for the end-user, explaining the order in which automated tasks were conducted and whether any issues were faced.
“Robotic process automation can free up employees’ time to focus on value-added tasks that might take more judgment, interaction, and interpretation. Ultimately, it enables a work-life balance, improving employee satisfaction, and, ultimately, retention,” Shannon said.
Application in clinical trials
The complexity and large scale of clinical trials are supported by many processes that run in the background. These require regular reporting, heavy data administration, and strict data quality maintenance.
“The clinical trials sector is ripe for transformation using robotic process automation,” said Ava Lu, Associate Director of Process Improvement at PSI CRO. “The first functions likely to be touched are ones that are heavy in documentation management, such as finance and accounting, supply chain, inventory management, as well as back-office processes like human resources (HR) and IT services.”
One of the biggest advantages of robotic process automation for clinical trials is that it can help capture a sequential record of the steps involved in every process, asserted Lu. Such audit trails can help streamline regulatory and drug safety data in clinical trials and ease preparations for regulatory inspections.
Robotic process automation can help optimize trial site management, which is a core component of ensuring trial completion within a set budget and a specified time frame. It can also be used to automate tasks involved in trial site management like contracting, payments, and patient monitoring, which are mechanical in nature.
Moreover, as the programming behind robotic process automation is language agnostic, all potential trial sites worldwide will be able to leverage the benefits of automation to the same extent, which wasn’t possible with traditional automation, noted Shannon.
It can also help accelerate patient recruitment or matching. Either by assisting in database querying to find suitable patients or by pre-screening patients for clinical trials.
Early signs of success
Anticipating the positive transformation that robotic process automation can bring about, leading CROs like PSI have already begun implementing it to accelerate internal processes.
“We have been working with UiPath, a global software company, to implement robotic process automation with the goal of becoming agile and adapting faster to market trends,” Shannon explained.
“We are now setting up the overall infrastructure within PSI. In parallel, we are starting to apply and test automation in our overall support functions like finance, HR, and IT. After this, we plan to focus on automating the clinical side.”
Although robotic process automation implementation within PSI is still in the early development stages, the team is already seeing some initial signs of success, including reduced manual labor, less data duplication, and improved data quality. This success has also served to boost employee excitement about the use of such transformative technologies.
There are also some areas unique to PSI, where the team hopes to leverage robotic process automation. As one of the few CROs with its own digital enrollment platform for patient recruitment, the team aims to be one of the first CROs to marry it into the in-house pre-screening of suitable patients who enroll online.
Lastly, while the programming that goes into the use of robotic process automation in clinical trials is disease-agnostic, therapy area knowledge is still crucial in clinical data collection, analysis, and management, cautioned Shannon.
“This is where our automation team works closely in sync with PSI subject-matter experts because we need this cross-functional interaction to get the best results out of implementing robotic process automation,” he explained.
The future of robotic process automation in clinical trials
Deliberating on how robotic process automation adoption in the healthcare industry will pan out, both Shannon and Lu agreed that getting over the resistance to automation is really the first step.
As an industry with extensive regulatory requirements, some remain concerned over how data security and protection are verified while using robotic process automation. There also remains a fear of moving away from the manual verification of tasks, the experts noted.
“The hesitation can be overcome by open cross-functional communication and the creation of an optimal business-specific strategy to implement robotic process automation.”
“This involves starting with small steps of mapping processes to find repeatable tasks, setting up the infrastructure and security essentials, and then slowly trialing robotic process automation across functions in a structured manner,” Shannon explained.
“Strategic thinking and patience are key because with robotic process automation you see a digital transformation within the enterprise which may be slow at first, but it quickly gains traction.”
And despite the initial fear, the future of technology in the clinical trial world looks promising. With signs of increasing adoption of innovative tools like robotic process automation and machine learning, streamlined clinical trials with higher accuracy, shorter turnaround times, and cost-savings are within reach in the near future.
Click here to learn more from Doug Shannon on how you can build resilient automation and centers of excellence to scale automation throughout your enterprise.
To learn how you can partner with PSI for successful clinical trials powered by the latest technologies, please visit the company’s website.
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