Gregory Kloster

Leveraging Opportunities in Life Sciences with Business Process Management

When Contract Research Organizations improve operational efficiency, they can better manage clinical trials, improve speed to market, and reduce costs.

by Trevor Naidoo, July 2011

The past decade has seen a steady climb in spending on research and development (R&D) at pharmaceutical and drug companies. At the same time, new drug approvals have been flat. This has resulted in part due to three major challenges. 

  1. Operational efficiency and effectiveness: Most life sciences organizations struggle with their clinical data and trial management processes to support clinical research goals and to drive measurable results.

  2. Protocol management and compliance: Organizations are challenged with sharing knowledge about research collaborators to adequately manage protocols and compliance

  3. Quality data management: Data is dispersed across multiple sites and needs to be efficiently consolidated and integrated

In 2010, R&D spending was down for the first time ever — three percent over 2009. Experts cite poor returns on pharmaceutical R&D as a key reason, with research productivity being arguably the single biggest contributing factor. According to AMR Research, “most pharmaceutical and biotech companies outsource portions of their clinical trial management process today; however, nearly two-thirds have changed suppliers at least twice as they seek strategic relationships that yield measureable results.”

This presents some opportunities for contract research organizations (CROs) to help large pharmaceutical and biotech companies to overcome the challenges mentioned above, and to become a strategic partner.

Opportunities for Contract Research Organizations

Increased R&D outsourcing: More pharmaceutical and biotech companies continue to outsource large portions of their R&D. CROs who can demonstrate their ability to meet the ongoing demands of their clients, such as patient safety, cost management, data integration and compliance will be successful.

Clinical trial management: CROs can do a better job managing clinical trials to reduce costs, speed time to results, and improve data quality.

Niche markets: With a growing trend towards specialized drugs targeted at precise population groups, CROs need to understand which organizational and system changes they should make to support a highly diversified portfolio of clinical trials.

Operational optimization: CROs can improve operational efficiencies and outcomes in trial management, deliver real-time visibility across all operations and acquisitions, increase the quality of clinical data with electronic data capture, and optimize systems and tools to provide global scalability.

Compliance and regulations: CROs can help ensure compliance with regulatory, government and industry norms without substantial increase in costs.

Three Ways BPM Can Help

Business Process Management (BPM) is a strategy and technology that delivers value to the organization by impacting both the top and bottom lines of an organization. This technology will not only bring quantifiable value to the organization, but will do so without a corresponding linear increase in investment. Here are three ways that BPM can help the CRO industry.

  1. Agility: BPM can provide the agility needed in today’s rapidly changing business environment. Process automation is one way that BPM can help an organization become more nimble. Business processes organized within a BPM framework are well-documented with clearly-defined steps. Moreover, there is a clear understanding of the underlying systems and data supporting each process step. Changes to existing processes can be made quickly within a BPM framework because the downstream affects on people, systems, and data are already known and factored. Automated processes within a BPM framework also help in providing speed to compliance as well as transparency and consistency in the execution of the business processes. Speed to market is yet another key driver for more agile business processes. To remain competitive in today’s environment, CROs need to be able to exploit new market opportunities much faster than their competitors. For example, the study startup process may be slightly different for each client, but is treated as a unique process for each client to accommodate the specific nuances for that client. BPM can provide a flexible process framework that can accommodate the unique requirements for each client, but still leverage the overall process to gain economies of scale.

  2. Visibility: In this fast-paced world, executives need information in real time. Without automated processes, it is very difficult to gain real-time insight into the execution of business processes such as the clinical trials process. BPM technology not only provides the ability to automate the processes, but also provides the ability to monitor the performance of the processes in a real-time manner. This capability allows management access to fast and accurate reporting so that they can make informed decisions about the business. The information can be rendered via portals so that decision-makers can have the information they need in one place. The study start-up process requires coordination across many different specialists, sites and organizations with multiple documents and templates being used, which makes it very difficult to have visibility into the process at any point in time. BPM technology helps automate and track the entire end to end process making it possible to gain visibility into the process at any point in time. This level of visibility is also important for compliance.

  3. Efficiencies: BPM can bring tremendous cost savings and cost avoidance to an organization. Optimizing and automating business processes can lead to a reduction in redundancies. Most manual tasks can be eliminated, considerably decreasing the risk of errors and rework in the process. In the study startup example, most organizations rely on manual efforts to validate and verify information captured along the way with several manual handoffs. BPM can help eliminate most of the validation steps and manual handoffs. Gartner claims that by simply “making the current-state handoffs, timing and responsibilities explicit,” productivity improvements of more than 12 percent are typically realized. In addition to automating manual tasks, BPM can help automate the end-to-end process involving both human and system tasks. These efficiencies will help CROs win more business, and make their current business more profitable.

Large pharmaceutical and biotech companies may have different needs when outsourcing their clinical trials processes. Having a common platform that is flexible and nimble will give CROs economies of scale, while ensuring that processes are executed consistently with high quality. 

Trevor Naidoo is a senior director in Industry Strategy and Insight at Oracle