Best Practices for Clinical Trial Operations Using Workflow Management Solutions

There are a few systematic fundamentals that must be realized—whether centralized or otherwise—in order to reach maximum potential for productivity improvement in clinical operations:

• Managers must have complete visibility to all tasks being performed on a particular trial at any given point in time

• End-to-end operational processes must be designed for optimal workflow and efficiency

• Managers must be able to assess overall progress towards trial milestones and be alerted to any potential delays or issues in a timely manner

• Resource allocation and overall productivity must be evaluated using clearly understood and consistent metric outputs

• Internal and external customer transactions must be handled in a timely manner that considers historical context, escalation paths, follow-ups, and cost-effectiveness.

There is a perceived loss of control—whether considered legitimate or otherwise—when certain operations, no matter how routine, move offshore. Even the basic requirements above may be perceived to be at risk. It could be argued that clinical trial project managers, for example, like to know exactly who is doing what work on their trial at any given time, and are comforted by the existence of tangible resources with whom they can interact throughout the study start-up and execution.

Best-in-class companies rely on rigorous process evaluation and improvement techniques to retain their competitive advantage. Clinical trial operations support has particular needs in this respect, all of which must work in concert to realize optimal efficiency gains.

The goal then is to establish that technology is a key driver in facilitating these processes through the use of relatively simple workflow management systems, whose purpose is to ensure that:

• Work is accomplished in a timely manner

• No task "falls through the cracks"

• Resources are "leveled" appropriately

• Process efficiencies are maximized

• Bottlenecks are immediately identified

A workflow management system must contain a running audit of all tasks and processes at any given point in time. Business rules control the queuing and distribution of tasks to work groups. Alerts are used to notify users of tasks that need to be handled within a given time period. Reports and dashboards are used to aggregate and display relevant information.

The system in a clinical trial operations setting must allow users to define different workflows for different types of jobs or processes. At each stage in the workflow, one individual or group is responsible for each specific task. Once the task is complete, the workflow management system should have the capability to ensure that those responsible for the next task are notified and receive the data they need to execute their step in the process. If a task is not completed in a designated time frame, a business rule should fire and a notification should be sent to both the responsible party and a designated supervisor.

A workflow management system that is designed to encompass the entire clinical trial start-up and execution processes should also provide on demand reports that pinpoint areas of concern, whether for a particular trial or comparative analysis of a group of ongoing "like" trials. Such a tool would enable project managers to plot "expected" progression through a trial and then match these projections to reality.

For example, some applications* will show exactly where performance has not matched expectations by aggregating data from multiple tasks and comparing this information to the original projections. An on-demand report might show that for Trial X, only 50% of site contracts have been processed compared to an expectation of 65% at a given point in time. Thresholds can be set to trigger an alert that intervention may be necessary to avoid jeopardizing downstream activities and a "drill down" into the details to show exactly who last worked on a particular task, when it was handed off, and how long it has been dormant can be accomplished.

By enabling users to create business rules that dictate system responses to several clinical trial variables (i.e., indication, phase, complexity, major milestones, etc.) a clinical workflow management system can monitor trial progress and generate comparisons to "apples-to-apples" historical or ongoing trials. These business rules can then generate metrics that allow high-level monitoring of progress via the use of dashboards and other forms of report.

The set up process for trial workflow should be intuitive and, apart from the initial installation, should not require IT maintenance. The tool should allow users to quickly translate a process such as trial start-up into a system workflow that reflects exactly how tasks are handled, including decision points, handoffs, and milestones.

A user must be able to rapidly set up the properties of a particular trial, including roles (such as investigator, contract administrator, project manager, etc.);tTrial details (products, sites, IRBs, key milestone dates); events and statuses (such as CTA signed, budget accepted, regulatory documents submitted, IRB approval, etc.), actions, and notifications (business rules that fire when a particular task needs to be handled or escalated).

Robust on-demand reporting of ongoing work and overall trial progress, as well as metrics that clearly demonstrate opportunities for improvement in efficiency, cycle time, timeliness and quality are critical to managers. Managers also require forecasting algorithms that are based on a detailed understanding of upcoming trial workload. All of these functions may be contained within the workflow management application, or may be achieved using a combination of outputs from the system and workforce management/trial complexity algorithms.

For example, the workflow management system should be capable of producing both an "as is" report on work status in every trial, as well as graphically projecting how the current situation compares to the ideal, based on predefined trial milestones.

From the internal perspective, the focus is initially on managing all forms of contact, whether these are electronic or hard copy inbound or outbound documents, telephone conversations, e-mails, faxes, or web portal transactions, and subsequently using appropriate technology to generate, track, review, distribute, approve, and/or file the information through various media.

Workflow management systems are not necessarily intended to optimize all aspects of customer interaction, but rather to work in concert with existing technologies, such as IVR and customer relationship management systems. For example, if a clinical operations environment can leverage pre-existing computer-telephony integration implementations to streamline customer interactions, the workflow management system will augment the efficiencies realized by this process by enabling follow-up tasks to be immediately logged and expedited using pre-existing business rules.

Michael Cusack is a Senior Consultant with Transformation Associates, Inc. http://www.transassoc.com/ e-mail: mcusack@transassoc.com.

*Such as the product preciseCLINOPS® from the author’s company Transformation Associates.