Implementing An End-To-End Clinical Development Process Framework

By Neil Conroy and John Cassimatis, Grant Thornton

Clinical trials are complex undertakings requiring a high degree of coordination among many parties using a myriad of IT systems, processes, and SOPs. Large pharma organizations pose an added challenge given their global scale and the volume of trials in progress. For example, a well-known large pharma organization logged over 40 systems, 150 SOPs, and 1,000 other documents involved in trial execution. These systems and processes have a large user base, which is partially organized into task-orientated functions (e.g., site monitoring) and therapeutic or geographic functions. If we take for granted that there will always be new and changing processes, systems, and digital platforms and the organizational complexity within Big Pharma will not abate, how do we ensure we optimize the entire clinical trial process and make the best use of our technology and process investments? The answer lies in fostering a process-centered view of this world via the implementation of a business process management (BPM) approach. BPM can successfully build the foundation for a high-performing organization by marrying systems and digital platforms to the process and the people working in it.

What Is Business Process Management?

If you search for “BPM,” the responses might lead you to believe it has something to do with implementing software to take processes digital. This software typically has the capability to document and manage workflows, moving paper processes to virtual ones as well as modeling processes. This is all well and good, but true BPM isn’t about adding another IT system. It’s about developing a process enterprise. A process enterprise is one in which people have an end-to-end view, where they follow a process according to its design. Where they still execute tasks, but they think process.

Fundamentally, BPM involves proper documentation of a process, mechanisms to monitor the health and performance of that process, governance of that process to ensure it’s properly executed, and driving continuous improvement and operational excellence in line with overarching organizational strategy. The most important enabler to achieve this is engagement of key individuals in the organization who take ownership of end-to-end processes and systems and fashion them into a productive network to drive improvement.

Cultivating end-to-end thinking results in people getting out of their function and considering what’s happening both upstream and downstream from where they are in the process. It also means knowing how their process performs objectively via metrics and measures.

How To Get Started

To address BPM holistically requires a framework and business process maturity model. The model dimensions are:

• process framework — current state of process documentation, ownership, and information availability
• skills and capabilities — the knowledge, expertise, and training of the individuals working within the value stream (where value stream is a collection of processes oriented to delivering value to the customer)
• systems and technology — current state of systems and technologies that support the value stream processes; the systems and processes must be aligned
• strategic process alignment — degree to which roles, responsibilities, and decision making are understood within and across the value stream
• innovation and continuous improvement — documented future state plans for processes and technologies, taking into consideration process/system performance, benchmarks, and regulatory intelligence
• culture — evidence of how leadership, teamwork, and change management are used to deliver on the value streams
• KPIs/metrics — measurement of process and value stream performance and their use in driving business decisions.

Each value stream can be evaluated using a four-point scale for each dimension. This evaluation process yields much more than a score; it yields insights on structural, cultural, and tactical levels.

Creating An End-To-End Clinical Development Process Framework

Creating an end-to-end clinical development process framework basically means identifying the major value streams and their sub-processes in a manner that makes sense and includes their inputs, outputs, and relationships. Key to doing this is defining the scope of the entire value stream. For clinical operations, it could span from the decision to do a study to the point when results are filed. The highest-level process segmentation might look something like this:

Underneath each value stream segment would be level-two and level-three processes, which would be more detailed breakdowns as defined in process maps. In regulated environments like pharma, SOPs and accompanying documents can be linked to this structure at the appropriate level.

Forming A Network Of Process And Systems Owners

Once the process framework is established, people can be designated to “own” that process. As process owners, their primary responsibilities are to:

• create and maintain the design of the process
• ensure training is adequate
• assess process performance
• be aware of audit observations, investigations, and ongoing CAPAs
• ensure new regulatory requirements are incorporated into the process design
• ensure systems and associated modifications support process execution

Other key roles include:

• Value Stream Owner — The glue that holds together a collection of process owners in a value stream (e.g., all study startup process owners) to review process performance and drive improvement. This person could be within a business process center of expertise, rather than in a functional business role.
• Systems Owners — Obviously they are responsible for a specific system (e.g., clinical trial management system or electronic clinical outcome assessment). Since systems can touch many processes, these individuals must be judicious about how they interact with process owners.
• Value Stream Sponsors — Business leaders who ensure the overall strategy is linked to value streams and their associated processes and who also act as an escalation point for process issues.

Combining All Elements To Drive Improvement

Process owners alone cannot keep track of all of the aspects of a process in global clinical organizations, so they need to draw on a network of people including other process owners, subject-matter experts, value stream owners, sponsors, systems owners, and quality and regulatory experts. Process owners should drive regular interaction with these people around a structured agenda to capture and discuss process-specific information. The value stream owner should also regularly review process performance, prioritize improvement opportunities, and act on those opportunities as part of an annual improvement road map or future-state design.

Conclusion

Executing the steps outlined above to create a process enterprise is not an end in itself. Rather, it’s the first step to drive end-to-end thinking across an organization. Given the inherent complexity in clinical organizations, it’s imperative that employees understand their work and how it fits into the bigger picture. This is an understanding only process thinking can enable.

About The Author:

John Cassimatis serves as Grant Thornton’s Life Sciences Business Consulting Sector leader. Prior to joining Grant Thornton, he was cofounder and president of TayganPoint Consulting Group. (TayganPoint Consulting Group was acquired by Grant Thornton in October 2018.) Cassimatis has more than 30 years of experience advising and working with some of the world’s leading corporations in life sciences and other industries, assisting with major organizational transformations. His areas of expertise include strategy formulation and implementation, business process improvement, organizational redesign, change management, and information technology strategy. You can reach him at John.Cassimatis @us.gt.com.

Neil Conroy is a manager in the Operations Transformation practice at Grant Thornton. With over 25 years of experience in process improvement and operational excellence using Lean Six Sigma techniques across multiple industries, his areas of expertise include business transformation strategy and implementation, business process management and improvement, program and project management, coaching and facilitation, and change management. Conroy has initiated and developed improvement functions and led organization-wide improvement programs in complex manufacturing and R&D settings including pharmaceutical supply chain and manufacturing, medical device manufacturing, and pharmaceutical and clinical development. You can reach him at Neil.Conroy@us.gt.com.