Outsourcing and Robots: how smart pharmas are optimising R&D operations
pharmafile | April 5, 2016 | Feature | Manufacturing and Production |
Faced with steadily rising research and development costs, as well as increasingly stringent regulatory requirements, pharmaceutical firms are re-evaluating their operational strategies and assessing the potential of new technologies to optimise processes around clinical trial drug discovery and reporting.
Top-performing firms are finding that an effective Business Process Outsourcing (BPO) strategy, coupled with implementation of and Robotic Process Automation (RPA), can help pharmaceutical firms close the gap between rising R&D costs and profits.
For some time, pharmas have outsourced certain functions to Clinical Research Organisations (CROs) in efforts to extract move value from R&D investments. Indeed, managing CRO relationships has become essential for large pharmaceutical companies seeking to address the growing costs of getting a drug to market. By taking on many of the business processes associated with clinical trials, clinical data management and pharmacovigilance, CROs apply standard and consistent rules to nearly every process associated with clinical research.
Effective use of a CRO requires identifying which functions to retain and which to outsource. As with any sourcing arrangement, strategic, knowledge-based and value-add activities related to clinical research should be retained, while tactical and repetitive functions are well-suited to outsourcing. Tasks that are typically outsourced to a CRO include entry of data into statistical databases, checking data quality on completion of a study, monitoring protocol compliance, submitting data to regulators and clarifying anomalies and designing data collection methods. Many of the business processes involved in these outsourced tasks, meanwhile, are highly structured, consistent and repeatable. These people-intensive processes require staff to toggle between multiple systems and screens to achieve “last-mile” integration of clinical data checking, inputting, searching, collating or analyzing to report an outcome.
The potential game-changer for pharma is that that many of the processes managed by a CRO are prime candidates for RPA, which is ideally suited to any process that can be defined and consistently executed with minimal variation.
Within pharma, RPA applications eliminate much of the “swivel-chair” work that characterises clinical research by automating many manual process steps. This results in straight-through process compression as well as increased speed and accuracy.
Moreover, every action performed by an RPA tool is traceable and auditable, a key advantage in an industry where proof of compliance is critical. The built-in scalability of digital automation code and the modular architecture of process automation further reduces the need for people-based process execution. By enabling smart people to collaborate with digital robots, RPA creates an opportunity to achieve process optimisation.
In contrast to traditional automation tools, RPA applications are easily implemented and have minimal impact on IT-managed infrastructure or technology resources, CPU performance or network traffic. Bandwidth, storage and compute capacity requirements are similarly unaffected, and existing change management protocols are still applicable. RPA can reside on cloud or traditional platforms and, again, require no change in underlying systems or databases.
From a Human Resources perspective, RPA can be deployed in collaboration with IT or independent of IT staff support. Indeed, ease of deployment is one of the key enabling features of today’s RPA applications, and key advantages over traditional automation tools.
Another key advantage of RPA over other automation technologies is drag and drop functionality that eliminates the need for coding and programming, and enables integration with or replacement of existing automated systems. Again, this facilitates adoption and precludes the need for significant investment of capacity or human resources to manage the integration. Bottom line: for many applications robots can be configured in a matter of days.
The potential role of RPA in clinical research also gives client organisations a new set of sourcing options. With RPA, pharmas now have an alternative to full BPO with a CRO, as well as a lever to incent their CRO partners to adopt technical innovations to improve speed, accuracy and compliance at a reduced cost. In addition, automation could allow some sourced processes to be brought back in-house.
In other instances, pharma/CRO collaboration and gain-sharing models could drive innovative solutions. While the specific approaches will vary, expect pharmaceuticals and CROs to increasingly combine human talent with virtual talent as a central component of their competitive drug development lifecycle strategies.
Big Pharma today is characterised by a paradigm shift designed to deliver clinical trials through integrated healthcare systems, and to build networks with providers, key opinion leaders and investigators shaping the environment. Technology advances will become increasingly critical to both pharma firms and CROs, and both must invest heavily in technologies such as RPA to drive the efficiency needed to survive.
The main question sponsors must consider is how much control of the development process they are willing to transfer to the CRO. With the advent of technologies like RPA, sponsors now have the innovative capability that will require both sponsors and CROs to reevaluate their relationships.
