As pharmaceutical firms work to close the gap between rising R&D costs and profits in an environment of increasing regulatory control and testing, they face the challenge of securing approval and bringing new drugs to market – safely, efficiently and profitably.
To address this challenge, leading pharmaceutical firms are radically reevaluating their business and operational models and implementing strategic Business Process Outsourcing (BPO) through Contract Research Organizations (CROs) and Contract Manufacturing Organizations (CMOs). As CROs and CMOs grow in popularity as an effective way for pharma firms to handle all aspects of clinical discovery, many of the business processes associated with clinical trials, clinical data management and pharmacovigilance have become a key part of their services. Addressing these requirements requires many staff hours to handle continuous and repetitive manual processes.
The advent of Robotic Process Automation (RPA) RPA promises to change the game, by applying digital “robots” to perform high-volume, repeatable tasks which previously required humans. RPA provides a fast, secure and auditable way for sponsors and their CROs and CMOs to execute recurring and consistent processes such as entering data into statistical databases, checking data quality, monitoring protocol compliance and submitting data to regulators.
Unlike traditional automation tools, RPA solutions are easily implemented and have minimal impact on IT-managed infrastructure or technology resources, CPU performance or network traffic. They can reside in the cloud or through traditional on-premises applications, requiring no change in underlying systems or databases. Another key advantage of RPA over other automation technologies is its drag-and-drop functionality, which eliminates the need for programming or coding, and it can be integrated with existing systems. As a result, RPA can be implemented in a matter of days.
Industries such as insurance, financial services and other data-intensive sectors are showing increased interest in RPA. Since CROs and CMOs typically apply standard and consistent rules to nearly every process associated with clinical research, these repeatable and consistent processes are prime candidates for RPA, which is ideally suited to any process that can be defined and consistently executed with minimal variation.
Today, many clinical processes are still people-intensive and require high volumes of staff to toggle between multiple systems and screens to achieve “last-mile” integration. RPA’s capability to help ensure proof of compliance and the built-in scalability of digital automation code could significantly reduce the need for people-based process execution, and can improve speed, accuracy and compliance at a reduced cost. This automation can enable CROs and CMOs to focus on what they do best: provide clinical research expertise, instead of process-intensive reporting functions.
One key challenge RPA must address before being widely adopted in pharmaceutical enterprises is that of validation. In a regulated environment, any system that performs a decision-making function requires validation and solid change control. Specifically, any change requires re-validation to show that the system either interprets the input correctly and correctly executes the expected resulting action, or flags the transaction for human intervention. To date, we’ve not observed a pharmaceutical firm or a CRO apply RPA to manage validation, and firms continue to rely on people to perform this function. However, because RPA systems are precisely configured and auditable and are specifically designed to not “color outside the lines,” they have the potential to effectively address the validation challenge, and in fact could do so in a more reliable and accurate manner than humans.
While pharmaceutical innovation enables people to live longer and healthier lives, the innovation process is complicated by regulatory and reporting challenges. By helping to address some of the key administrative tasks, RPA is enabling pharma firms to focus on bringing safe and effective drugs to market at a lower cost.
About the author
Jenn’s experience managing complex engagements is complemented by her proven ability to help clients achieve the desired results from the sourcing process. She has developed sourcing strategies and governance processes for a number of Fortune 500 companies, decreasing consulting spend between 25 to 35 percent while increasing customer satisfaction and mitigating risks.