Workflow Management Systems for Mid-Size CROs


Applied Clinical Trials

Mid-size Contract Research Organizations (CROs) play an important role in the pharmaceutical ecosystem with their focus on quality of service and their ability to specialize in therapeutic areas. These organizations also leverage their low administrative overhead as a competitive advantage. However, the desire to maintain low overhead carries with it an inherent need for efficiency. Senior level managers of CROs face a number of key operational challenges including the following:

  • Maintaining a low administrative overhead while scaling operations

  • Ensuring that all billable hours  are captured in an accurate and timely fashion

  • Reducing the risk of study costs exceeding budget

  • Maximizing staff productivity by providing it with the appropriate tools and resources

  • Maintaining or improving organizational agility by automating certain processes

A well-designed and flexible CRO workflow management system can address all of the above challenges. Automating processes such as the generation of study estimates and quotes, and monthly invoicing can help control the administrative overhead and ensure that it does not scale exponentially with the number of studies. A system that provides Clinical Research Associates (CRAs) and other project staff with “intelligent” timesheets that are easy to use ensures that billable hours are recorded accurately. Real-time visibility into the study costs, budgets, and revenues empowers senior management to make the right decisions regarding resource allocation and to engage discussions with clients before study costs exceed budget. Finally, providing staff with a system that is easily accessible from both the office and remote locations improves productivity and helps ensure user acceptance of the system. A well-designed workflow management system also takes into account the organizational culture of a CRO by implementing processes without adding levels of bureaucracy.

What exactly is a "well-designed" workflow management system?
CROs have a unique set of attributes as compared to other project management organizations–a simple example being the broad range of activities in which the clinical research team is typically engaged. These unique attributes must be taken into account when designing an effective system. Typically, in the absence of a workflow management system, CROs maintain study-related information using a variety of spreadsheets, databases, word processing, and other software. Various in-house or web-based timesheet systems are also typically used to record time spent by staff on study- and non-study-related activities. However, such disconnected and discrete databases preclude the smooth flow of information throughout the lifecycle of a study.

Let us consider the example of a CRO that requires its study team members to work on studies to diligently record their time. At the end of every month, detailed reports can be generated based on the information recorded in the timesheets. For each study, these reports will show the exact amount of time recorded by each member of the study team relating to a variety of activities. However, the utility of the reports is limited by the quality of data that has been entered by the study team. Stand alone timesheet software typically has no knowledge of the activities that have been contracted by the sponsor for any given study. As a result, study team members are not restricted in their choice of activities when completing the timesheets. Since staff are not presented with an intelligent choice of activities based on the study contract, there is no consistency in the way the time is recorded and identifying billable out-of-scope activities becomes a daunting task. Such a setup becomes the perfect illustration of the database concept of “garbage-in-garbage-out."

A well-designed workflow management system, on the other hand, integrates the entire operational lifecycle of a study from pre-sales processes such as the generation of estimates and quotations, to post-sales processes such as invoicing and reporting (e.g., financial, study status). Automating the estimation and quotation process lowers the administrative overhead associated with these tasks in multiple ways; it enables the user to easily create a detailed cost estimate of the study by identifying all of the various activities needed to fulfill the sponsor’s mandate, associates the appropriate resources that will perform those activities, and budgets the hours required to complete each activity.
Automating the estimation and quotation process also increases the accuracy of the recorded billable hours by presenting the study team with “intelligent timesheets." An intelligent timesheet has knowledge of the study team members and the activities that are part of the study. This information is entered by the user when the quotation is created and the study is initiated. Should an employee log time against an activity that is not part of the study, it is automatically be marked as “out-of-scope” in the timesheet reports and becomes a potentially billable event.

While the professional fees in a study quotation represent the CRO’s revenues, the hours attributed to the various activities in the timesheets represent the actual cost of a study. A system that captures both of these components empowers management by providing it with rich reports that give real-time visibility into the profitability of an ongoing study (see Figure 1). Additionally, the ability of intelligent timesheets to easily identify out-of-scope activities as they are entered ensures that budgeted study costs are not exceeded without visibility.

One area where senior management in a mid-sized CRO can spend a significant amount of unproductive time is with monthly invoicing. Having key data such as quotations, contracts, payment schedules, pass through expenses, timesheets, and site monitoring information in multiple places can complicate the invoicing process for even the most organized manager. A well-designed system automates the entire invoicing process since the data needed to generate an invoice is captured well in advance of when the invoice needs to be issued. In such a case, the invoicing process becomes a simple act of integrating all of the relevant information from the system into the appropriate document template used by the CRO.

Another important attribute of a well-designed CRO workflow management system is its ability to empower senior management to run the organization more efficiently by providing rich reports that present key metrics such as revenue projections and resource utilization (See Figure 2 and Figure 3).

What are some technology considerations for a mid-size CRO?
The work processes in a CRO are different from those of many other professional services organizations. For example, CROs typically deal with many different types of stakeholders.  A CRO’s client contacts (both current and prospective) typically include senior level executives, project managers, coordinators, and increasingly procurement managers.  Additionally, CROs interact with clinical sites, physicians, site administrators, and coordinators. A CRO-specific workflow management system must capture all these relationships and ensure non-duplication of the information and of the data entry processes.

With mid-size organizations, there is generally a need for business systems to have a high degree of customizability, and a relatively low degree of bureaucracy. The culture of an organization also plays a strong role in determining the level of approvals required for internal processes. For an organization with a “flat” management structure, a common sense approach to design leads one to adopt a system of checks and balances rather than a system that requires approvals for all activities. One also needs to consider scalability. A system must support the company’s growth, both vertically (in terms of number of employees) and horizontally (in terms of new services and lines of business). Finally, the system must be easily accessible remotely in order to accommodate staff, such as CRAs, who spend a considerable amount of their time traveling.

However, one of the most important considerations when choosing a technology (one whose impact is often underestimated) is the choice of implementation partner. A partner who understands the business, the organization, and the company culture can bring intuitive benefits to the technology that is ultimately adopted.

Are best practices a myth?
Many software solutions claim to have incorporated best practices into their processes.  These practices are typically the software company’s generic solutions to well-known process issues. To assume that a single solution can be applied universally, and that dramatic improvements can be expected across the board is highly flawed thinking. Simply because Company A succeeded in resolving a process issue by adopting a particular approach does not mean that Company B can expect the same outcome by using a plug-and-play implementation of the same practice, even if the two companies operate in the same industry. For mid-size organizations, process issues can be stifling. Two CROs of the same size may have vastly different cultures that have developed over the years and these organizational and cultural differences play as important a role in determining the ideal solution as does their size.

One must also consider that there are hidden costs when a company changes its business processes to adapt to the so called best practices requirements of the software system it has adopted. Though some of these costs may not be obvious, they manifest themselves in lost productivity as a result of the reengineering of internal processes required. Some of the changes may even conflict with core workflow processes within the CRO.  Instead of selecting a system that imposes a set of rigid, pre-defined practices, it is far more beneficial to the CRO to adopt a system that hones the efficiency of existing internal process. Rather than ask “How should we change our processes so we can work with this software?” a far more relevant and powerful question for a mid-sized CRO to ask is “How can our processes be made more efficient with a powerful system?”

Doesn't it take a long time to implement these systems?
Not necessarily. When Mindprint implemented a workflow management system for managing all HR, CRM, study estimation, quotation, timesheet, and invoice-related processes for ethica Clinical Research Inc. in 2011, the entire implementation took less than four months. This level of speed can only be achieved with a technology that has customization at the very core of its architecture. By engaging key stakeholders at ethica Clinical Research Inc. early in the design stage, Mindprint was able to get a deep understanding of the complexities of ethica Clinical Research Inc.'s business processes, distill the processes into a series of simplified workflows, and ultimately develop a system that suited the company's needs. All of ethica Clinical Research Inc.’s work processes were mapped into an Axpert-based system, including customer relationship management, human resources, operations, timesheets, and invoicing. Axpert’s no-coding approach ensured that the implementation (including design, development, installation, and data migration) was complete in less than four months as compared to the years that other systems often require. An iterative approach ensured that the key users at ethica Clinical Research Inc. were highly engaged during the entire implementation process, resulting in a workflow management system that perfectly suited the company's business objectives and its unique operational processes.

Editor's Note: The authors of this paper will present a case study around this article at this live webinar "eClinical Choices for Small to Mid-Size Companies."

Prasad Sristi is Founder, President Mindprint Inc., and Ron Kolanitch is Corporate Director of Business Development, ethica Clinical Research Inc.

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