Clinical Operations Process Automation – an 'e-Solution' Target?

Why clinical operations? Over the last 2 decades there has been a great deal of work by pharmaceutical and biotechnology companies and their software vendors to provide computer-based tools for clinical research and operations.

We have CDMS, CTMS, CSMS, IVRS, RDC, safety management and reporting, document management, project planning and scheduling and a host of others. Despite all these tools , organizations are consistently overwhelmed and behind schedule. While the tools available allow organizations to track masses of data and control processes, they do little for worker process control and overall efficiency. Instead, they add to the complexity of most workers’ tasks by requiring them to log and track their work in the systems identified above. Despite access to these tools, our work is complicated by schedule slips and growing communication gaps. Is it possible to automate the underlying processes of clinical research that connect all of the communications, documents, data and control information? For many clinical development organizations the answer has often been bluntly stated that the scientific research process cannot be automated due to the high level of specialized-knowledge worker input required. In the past I often agreed, but I have changed my position over the past three years. This article explores that change of perspective, what brought it about, and the results of successful clinical process automation.

What are 'e-solutions'?
In my initial research for this article, I googled “e-solutions” and then “e-solutions pharmaceutical” to find a simple current definition of this popular term. What came back was so many links it was impossible to check all of them fully. None of the first two pages of either search provided any clear indication of what constitutes an e-solution. I checked Wikipedia and Wiktionary and no information was available there either. I’m left to proceed, like many other writers, by defining the subject for my readers and myself. I would posit that an “e-solution” is an application of electronics-based technology to solve a known business problem. Simply stated, an electronics solution is now abbreviated to “e-solution”. This is perhaps a bit broader than the intention of the current usage in the pharmaceutical industry but lets examine how the history plays out.

'e-solutions' history
In the broadest sense of the term, information technology has been deploying 'e-solutions' for years, as each of the following can be considered an e-solution: Central Mainframe Applications, Departmental Computing Applications, Personal/desktop Computer Applications, Client Server Applications, Thin Clients, RDC, IVRS, EDC, No Client Browser Applications. The contemporary usage of the ‘e-solutions’ term focuses on some specific technical and procedural contexts. Today’s applications marketed as ‘e-solutions’ seem to infer these attributes:

• User friendly web-browser based interfaces
• Data entry as close as possible to the creator of the source data
• Data access with consumer-specified format and level of detail
• Centrally managed data by the owner/supplier of that data

In the evolution of information technology, applications have moved from static gathering and presenting data to the contemporary focus of source verifiable data entry/capture and consumer-specific data acquisition, presentation and delivery. With only minor exceptions, the business problems currently addressed by 'e-solutions' in the pharmaceutical clinical research arena are the static change controlled gathering and distribution of data.

Clinical operations process
What are the key processes in clinical operations today? Our organizations have prioritized the work and processes needed to collect, control and report data, track the changes made, and perform planning and scheduling. Our software vendors have built solid and focused tools to perform many of the complex tasks that are required. Having deployed all these tools, clinical operations are still a pressure point in the development process and needs to reduce the complexity and improve the efficiency and productivity of our specialised-knowledge workers. This is where my focus has been drawn, specifically to help clinical operations clients improve the underlying processes of communication, collaboration, notification and closure. The inter-organizational nature of these underlying processes demands an open collaborative environment with the broadest possible interaction of all participants.

As clinical operations applied 'e-solutions' to critical process targets in the past, we gained only limited control of the underlying processes (e.g. EDC for enrolment, randomization and supplies communications). However, my experience tells me that there are new and better targets equally important to clinical research efficiency and overall quality. In W. Edwards Deming’s classic text on statistical process control (Out of the Crisis, MIT, 1986) he used the “Red Bead” experiment to clearly show that the problems being experienced in manufacturing processes were the result of the process being used and not the people doing the work. In the context of the “Red Bead” example, red beads are incorrect products produced by a process that should only produce correct and high quality white beads. Clinical research organizations have consistently expected clinical operations to produce similar standards of our own white beads, yet many red bead results continue to be produced. What are clinical operations white beads? A representative sample includes: clear timely communication, consistently available and applied SOPs, collaborative decision participation from all stakeholders, timely notification, on-time enrolment, rapid data collection and correction, on-time submittal of material to regulatory agencies, quality information and audit ready process tracking.

I have tried to think of application software, or 'e-solutions', in a similar way. Thus, my conclusion that the problems we experience with both historical and contemporary clinical research 'e-solutions' are rooted in the processes automated, not on the technology used or the users of that technology. We have applied process control and automation to the massive amounts of data we have to deal with and yet our central collaboration and communication processes have been left to individual preference and manual complexity. The result is clear; we are routinely working in crisis mode. Something has to give, and hopefully not the backs and brains of our specialized-knowledge workers as our collective workloads increase and budgets tighten.

Is an “e-solution” possible?
Absolutely, YES! All we need to do is look to the evolution of the relational internet services such as LinkedIn and Facebook to see successful adaptation of broad stakeholder communication and collaboration information technology at work in controlled environments. It is in this context that I have tried to move the creation of application software requirements with clients, and in Integrated Clinical Solutions’ products, away from a principal focus on data capture and presentation services to include the underlying work processes being performed for contact management, trial planning, site initiation and management, subject recruitment and visit management, control and exchange of documents, and to communicate issues and enable collaborative resolutions. This is a much more complex requirements development process. This effort requires knowledge workers and their managers to analyse and understand what they are doing in the correct sequence to produce their desired results at a deeper level of complexity. A clear and well defined process that links our silos of ‘e-solution’ automated tasks is critical to moving forward. When clinical operations and their vendors succeed in defining these more complex underlying process-driven requirements; we can begin to build process automation 'e-solutions' that will dramatically improve our efficiency, effectiveness and quality.

Will the effort required to make this shift of focus for clinical operations ‘e-solutions’ be worth it? Yes. Will we make mistakes along the way? Of course. Will we learn from these mistakes? Only by intentional effort. We need to push into this new arena and persevere despite the obstacles. In Tom Peter's classic ( In Search of Excellence, Warner Books, 1984) he builds a clear case to bias our organizations towards action. Professor Peters advises that when you have a major problem, pull together and solve it, “Learn from your tries. That's enough.” This theme, now commonly known as failing forward, has been emphasized repeatedly by many authors and trainers, and we need to take the risks required to make progress.

The potential ROI on software with these capabilities is hard to model, but consider the value of not needing to keep paper and email trails for query resolution, and the value of having the current version of each trial related document available for simultaneous reference by all personnel regardless of location, and these major collaborative processes just scratch the surface of the potential value. This direction can well bring our clinical operations organizations “out of the crisis” in the same way Deming’s work revolutionized the hard parts and products manufacturing organizations, particularly in Japan’s post World War II economy.

An example
Integrated Clinical Solutions’ niche offering is focused on automation of the underlying work processes in clinical operations. We have produced an internet infrastructure, process focused, collaborative work environment targeted to the needs of clinical operations within pharmaceutical, biotechnology, and device development organizations. The environment design first acknowledges that the stakeholders in these processes are many. Specifically, Sponsor companies, Contract Research Organizations (CROs), Principal Investigators and Sites, and other stakeholders must all be enabled to participate collaboratively in a complex process that spans all of their organizations. We have initially focused our work on the clinical operations organizations of both Sponsors and CROs as the central managers/performers of the clinical research and development processes.

Our recently released product 'inclinical perform' addresses many process-focused requirements for clinical operations organizations and their collaborators with trial planning, management and conduct functions. The work environment is structured on a clinical Program/Trial/Site/Subject/Visit data/process hierarchy rather than on any specific stakeholders process component. This allows all stakeholders to perform their work within a common structure. Common central clinical operations processes have been modelled such as subject visit planning, enrolment planning and management, document version control and exchange, issue/query posting, communicating and closure, and more. The ‘inclinical perform’ architecture is designed to support the incorporation of specific workflow automations in the context of the commonly used process hierarchy. A process for digital photography image acquisition and management has been deployed successfully and two more are currently in the pipeline. Resource management functions are provided that allow the central system owner, usually a Sponsor or CRO, to control the raw materials of the processes (e.g. people, addresses, organizations, substances, document library) separately from their use in the clinical operations functions shared by all stakeholders.

Conclusion
Our clinical research and development industry has just begun to scratch the surface of what can be done with contemporary information technology and process-focused ‘e-solutions’ approaches. There are many vendors working in this arena and yet most of them have not implemented a software requirements development paradigm shift from data capture and presentation to multiple-stakeholder clinical development process-based requirements development.

Our industry's clinical research organizations and their software vendors need a dramatic shift of focus towards process automation in a collaborative work environment and managing the risk of moving forward. We must make these changes if we are going to succeed in moving effectively and profitably into a new era of globally interconnected stakeholder processes for clinical research and development. If we continue to push the envelope on what can be accomplished, we will grow our process understanding and automation to a level that releases our critical specialised-knowledge workers from the chaos and crisis of individual manual methods. Adopting the more productive and efficient controlled activities of underlying process automation will return their primary focus to performing good clinical research science with white bead quality materials.