Transforming Clinical Operations Support

How to leverage workflow management solutions

By Michael Cusack
Transformation Associates

In an era of ever-increasing demands for cost containment in the area of clinical support, it is crucial to fully understand whether operational resources are being assigned to Trials and related tasks in a cost-effective and skill-appropriate manner.

There are many high volume, low complexity tasks that may be appropriate for non-trial-specific workgroups. These include data entry, scanning, document tracking, filling and storage, routine site correspondence and follow-up, order placement, labeling, blast faxing, etc. Other tasks — such as monitoring drug supply, creating data gateways, setting up site feasibility, negotiating contracts, IRB submissions, data analysis, and budget evaluation — require more specialized attention.

Optimally, clinical trial operations support managers need to avoid dedicating valuable resources to the ‘peaks and valleys’ of work associated with individual trials during start-up and maintenance. Instead, a consistent flow of tasks across multiple trials is required in order to optimize resource allocation.

In order to realize maximum potential for productivity improvement coupled with seamless operations support, several things must be in place:

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

A key question at this point is whether the facilities already exist within the company for you to realize these needs. If not, how long will it take and how much will it cost to do so?

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 regard, all of which must work in concert to realize optimal efficiency gains.

For example, technology can help to facilitate these processes through user-driven workflow management systems. From the customer 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.

Management needs 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. Managers also require forecasting algorithms that are based on a detailed understanding of upcoming trial workload.

From a resource perspective, the goal is to achieve workload distribution that achieves optimal productivity gains without any loss of internal or external customer confidence. Such an approach will necessarily include task analysis (drilling down to the individual task level and assessing complexity, volume and average durations), appropriating staff to both broad-based and specialized trial support tasks, and developing skills so that your staff can handle more complex assignments in the context of clinical trial operation support.

To get the ball rolling along the road to productivity improvement, it is important to consider whether your clinical trial support operation is conducting its day-to-day business based on a solid understanding of exactly how much work is being done where and via which media.

For example, do you have reports or data sources that corroborate your assumption that resources spent a major part of the day responding to and initiating telephone communications with sites, vendors, and other external agencies? Do you know how much time your operations staff is spending in meetings, both formal and informal? What exactly does that ‘Other’ category — the one that takes a third or more of your resource time allocation — really involve? A rapid survey or non-intrusive time study can provide you with these answers.

Even when monthly reports from the time-tracking system indicate otherwise, it can come as a shock when a detailed cross-departmental time study reveals that at a given point, your clinical operations support resources are actually attributing up to half of their time to trials that are already in maintenance and even closeout, rather than being primarily engaged in those highly deadline-driven start-up tasks.

If yours is a typical clinical trial support operation, the likelihood is that after discovering a few ‘surprises’ in terms of workload and resource allocation, you will be left wondering what to do next. We will point out some ‘quick wins’ that can make a very big difference to the efficiency of your clinical trial operations support environment.

Customers and Technology Solutions

Just as the emergence of call centers completely revolutionized customer service, 30 years later we can only point to a select few that initially understood the intrinsic value of a carefully designed and helpful Interactive Voice Response (IVR) system, of how best to utilize Computer Telephony Integration (CTI), and of avoiding the pitfalls of outsourcing purely for reasons of operational cost alone, rather than efficiency gains and improved customer satisfaction. So too must clinical trial operations support managers be mindful of the potential for either exponential improvement or convoluted chaos when leveraging the existing infrastructure or implementing technology solutions that promise immediate returns on investment.

Make no mistake about it: contact tracking and workflow management systems have the potential to transform clinical trial support operations. There are enormous productivity gains to be achieved quickly within most clinical trial environments. Pharmaceutical companies that found it more convenient to outsource their support operations to CROs, or had the latitude to appoint a plethora of resources to individual trials, are now being forced to explore multi-trial task allocations to in-house support personnel.

Like traditional contact center operations, clinical trial support environments often involve the processing of high volume transactions, including telephone, e-mail, fax and especially paper and electronic documentation. Just as in the contact center, as many transactions as possible should be handled by frontline resources, leaving those with specialized (i.e., more costly) skills to handle lower volume, high complexity tasks.

Most pharmaceutical companies have already invested in sophisticated telecommunications and customer relationship management (CRM) solutions, which we will refer to as “contact management.” One of the first ‘quick wins’ towards achieving optimal efficiency in clinical trial operations, therefore, is to investigate the existing infrastructure in order to determine the feasibility of the following:

• Facilitating customer transactions via the usage of one trial contact number for all inbound callers, as well as centralized e-mail and fax management,
• Utilizing existing IVR and computer-telephony integration facilities to capture caller data and route calls to the most appropriate resource,
• Installing contact tracking facilities in order to create historical reference points and operational intelligence for those with a need to know, and
• Leveraging trial-specific web portals to facilitate site and other transactions.

“Many companies already have the infrastructure required to realize immediate efficiency gains in clinical trial operations support. It’s often just a case of understanding how to optimally leverage what you already paid for and installed.”
—Paul Gillard, Ph.D. chief executive officer, Transformation Associates

Of course, it is not simply enough to ‘centralize’ communications via the usage of existing technology. Supporting processes must ensure that:

• All inbound contacts are handled in a timely manner via the use of metrics,
• All inbound and outbound documents, hard copy and electronic, are managed via the centralized trial control hub, and
• Tasks associated with the processing of trial-specific documents are monitored and reported in order to identify potential jeopardies.

While metrics associated with contact handling times are typically facilitated by the existing technology, the second and third requirements above require the usage of a workflow management application if these are to function effectively.

It is possible that such a critical application may already exist within the organization. If not, there are several cost-effective alternatives to consider. The best applications will allow managers to track the progress of all trial documents while providing alerts as necessary to ensure that each task stays ‘on track.’ This is the type of core functionality that is an integral part of any successful effort to optimize clinical trial support operations.

Once you are satisfied that the current or future technological infrastructure is or will be sufficient to support all routing, tracking and reporting needs, then you are ready to look at your return on investment in terms of productivity and efficiency gains. For example, if you have an average of four clinical trial operations support resources allocated to each trial today, then how many resources will be needed if these silos are largely disbanded and routine tasks are centralized?

Resources

Even in the absence of a suitable workflow management tool, it is still feasible to realize efficiency gains by ‘tiering’ resources. Clearly, there are significant inefficiencies when these routine tasks are siloed by individual resource alignment to trials, regardless of complexity algorithms or other methods of assigning support operations staff.

In some cases, up to 80% of day-to-day clinical trial support operations work can be handled by frontline personnel who are responsible for multiple trials.

For example, project management may determine that a multi-site trial in a particular therapeutic area will require X dedicated support resources during a three-month start-up and Y support staff for maintenance purposes over the following 12 months. It stands to reason that although the ‘tried and trusted’ algorithm is fundamentally sound, these resources will be more or less busy over the course of the trial. As first patient visit approaches, work reaches something of a fever pitch. Similarly, a trial audit during the maintenance phase will cause a spike in workload. This approach is perhaps analogous to how an airline pilot once described his job: “Relative boredom sandwiched between two moments of pure unadulterated panic.”

In the meantime, other dedicated trial resources will experience similar ‘peaks and valleys’ in their workloads.

Not surprisingly, trials closest to first patient visits usurp the most support workload at a given point in time. While some dedicated resources are essentially idle in the ‘calm before the storm,’ others are utterly overwrought as a result of work silos.

Just as in any efficiently run service environment, workload balancing in clinical trial support operations is essential to productivity, cost savings and job satisfaction. Given the correct toolset, managers can aggregate all routine trial support tasks across the entire frontline (i.e., non-specialist) resource pool.

The broader the ‘tiering’ of resources across trial support tasks, the greater the potential for productivity gains. If managers cannot easily see who is doing what and monitor overall trial progress, then ‘tiers’ can soon result in ‘tears.’ A simple workflow management tool that can provide real time reports, jeopardy alerts and aggregated views of trial progress is the optimal solution. Coupled with the pre-existing contact management infrastructure and software, the trial support operation becomes transparent to those with a need to know how efficiently tasks allocated to this entity are being handled across active trials.

Another consideration in this respect is the allocation of ‘skills’ to individuals. Skills-based routing is commonplace in contact centers. What this means is that based on initial identification of the inbound communication, the contact or task is routed via the telephone system or the workflow management configuration to the most appropriate individual (or group of individuals) delegated as most proficient in that particular area.

Using a simple menu (or IVR) configuration when callers dial a dedicated number for a particular trial, the telephone system will route that contact only to an individual who possesses a skill relevant to the subject matter selected. If the first individual is not immediately available, the system will ‘bounce’ the contact to the next available person with that skill set, and so on. Similarly, when a manager delegates a non-standard task or ad hoc task in the workflow management system, that task (and its related deadline) appears in the queue of the individual or group most suited to handle that assignment.

Tiering and Skills-Based Work Allocation

In terms of managing productivity, even if all of the frontline resources are occupied at a given point in time, both the telephony and workflow management systems can be configured to push first-tier tasks into the queues of second-tier specialists, in order that these may be handled by anyone who possesses a particular background skill. This is all done systematically — managers just have to ensure that individual resource profiles reflect the correct skill sets.

Even without a workflow management system, of course, it is still possible to increase productivity across frontline operations. For example, management may decide to create logical tiers of responsibility for groups of tasks that span all trials. Rather than trying to manually manage task allocations across a large group of first tier resources, the tier is broken into ‘pods’ of individuals who are collectively responsible for clinical trial support operations for a subset of active trials. In terms of typical clinical trial support operations, this is preferable to the traditional model of dedicated individual trial resources.

In the above example, resources are defined by skill and tier allocations, again using a ‘pod’ structure. For example, resource ‘P1’ possesses skills 1, 2 and 3. These skills correlate with certain tasks (A, B, C, D, etc.). This means that any job related to one of these tasks will appear in that individual’s queue. Also note that certain individuals are shared by pods, to ensure workload balance is achieved.

Clinical Trial Document Control

Whether it is physically consolidated or geographically distributed, at the heart of every clinical trial support operation is what could be called the Trial Control Hub. This is where every conceivable type of clinical document, whether paper or electronic, is generated, received, reviewed, scanned, filed, tracked and/or distributed.

Each document that makes its way through the workflow management system was either generated from, or will be ultimately housed in, the control hub ‘library.’ Trial start-up documents must be tracked through their entire life cycle, and consolidated reports on progress towards trial goals must be available to management in real time. Business rules must be in place to ensure that all documents are handled in a timely manner.

Management Considerations

Apart from conducting a needs analysis based on the pre-existing technology infrastructure, the first steps towards optimization of clinical trial support operations include:

• Verifying or redefining the operational vision, identifying issues that may preclude realization of that vision, and formalizing strategies for overcoming those obstacles,
• Conducting a non-intrusive time study across the entire operation in order to understand how much time is being spent on certain work activities (e.g., regulatory document processing, drug supplies, contracts, investigator meetings, etc.), by which groups, via which media, and on which trials at which stage of execution,
• Conducting a walkthrough of the ‘as-is’ end-to-end support processes and modifying these as necessary to reflect the ‘should be’ state,
• Formalizing a task matrix which specifies the key properties of each task delegated to operations, including tier allocation, skill group, media type, volume, trial stage, frequency, systems support and time allocation,
• Forecasting workload and resource allocation needs based on future trial scheduling,
• Determining key productivity and efficiency metric thresholds and targets as a basis for future change,
• Building a transformation roadmap to minimize costs, maximize efficiency, harmonize processes and improve the quality of clinical operations support, and
• Creating a comprehensive change management plan, to include collaboration with mission-critical functions, such as project management and the field, and department and company-wide communication planning.

Verifying or redefining the operational vision, if not already strategically accomplished, can involve an initial assessment and the formalization of a “Transformation Roadmap”™ that is designed to quickly drive these strategic approaches to the tactical level. At the tactical level, tasks surrounding process definition, technology infrastructure, change management and collaboration planning, can all occur in concert.

Michael Cusack is a senior consultant at Transformation Associates, Inc. During the past 10 years, he has worked primarily with clients within the pharmaceutical industries. As the author of Online Customer Care (American Society for Quality Press) and several white papers and articles, he has focused on customer relationship management and the acquisition of business intelligence. He can be reached at [email protected].