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Applied Clinical Trials
As CRO business and operational models change, so do the opportunities for CRAs.
Operations management, a capacity planning discipline that has typically been associated with the manufacturing industry, is now being applied to the unique needs of the drug development process. Often defined as the design, execution, and control of a firm's operations—which converts resources into desired products and implements its business strategies—operations management usually functions through the measurement and evaluation of operations using business appraisal methodologies such as Lean and Six Sigma principles.
These principles, following a data-driven approach and methodology to identify nonvalue-added activities and eliminate defects, are able to maximize value by achieving the fastest rate of improvement in quality, cost, customer satisfaction, process, speed, and invested capital. Developed by Toyota, Lean takes an aggressive look at processes in an attempt to eliminate all "waste" (i.e., time, resources, and costs). Six Sigma aims to increase the predictability and replicability of a process. This theory, popularized by GE, measures the quality of an outcome against the planned objectives, ultimately seeking to remove variance from a process.
Within the pharmaceutical industry, a number of the larger companies are familiar with the concepts of Lean and Six Sigma, with many of them first applying them to their research and development functions. Application to the drug development process is not as widespread, although selected sponsors and outsourcing providers are now applying these concepts to clinical research in an effort to improve quality and reduce cycle time.
With benefits such as these, the question may perhaps be, "What took the clinical research industry so long to adopt these principles?" The following article will describe the relationship between the transition in the management of clinical trials and an increased interest in operations management for the CRA.
Over the years, pharmaceutical companies turned from in-house management of the clinical trials process to a totally outsourced model, relying on CROs to manage entire studies from beginning to end. However, as sponsors' experience with this method of pharmaceutical development matured, many of them identified issues of resource management and quality control, leading them to explore other options such as functional outsourcing.
In the functional outsourcing model, the outsourced provider manages specific functions within the study, while the sponsor maintains overall management and control of the study. This model has gained significant acceptance in the past 10 years, with major pharmaceutical companies transitioning from 100% in-house monitoring to as high as 100% outsourced.
Sponsors are increasingly interested in identifying functional outsourcing providers who are interested in operations management, believing that installing this discipline in as many parts of the drug development process as possible will increase productivity, quality, and consistency in clinical trials.
Taking both a top-down and bottom-up look at process functions to identify opportunities for the application of Lean and Six Sigma principles, one interesting area is the role of the CRA.
First, a little background. As the role of the CRA developed and became better defined, the typical career path was for the monitor to start a career with a CRO. Because CROs offer training and entry into the field, CRAs often joined these companies directly after completion of their undergraduate studies in positions where they could gain experience and learn their profession, working with some of the largest pharma companies in the industry. Ultimately, the CRA hoped the CRO would serve as a stepping stone to employment with one of these industry leaders. However, this is becoming a less realistic option.
Fewer monitoring positions are now available at the pharmaceutical companies, as sponsors increase their use of the functional outsourcing model. Thus, CRAs can choose to remain with the CRO in the hope of transitioning to another role with a pharmaceutical company or can progress within their CRA career with a functional outsourcing provider. The question is whether one option is preferable to the other. There are a number of answers—some of which are related to career progression opportunities and others that are more lifestyle driven.
In terms of career development issues, certain functional outsourcing providers appear to offer clear advantages over the CRO model. Here are a few:
Participation in operations management processes. The impact of Lean and Six Sigma is being felt at all levels within certain functional outsourcing providers, including the CRA position. CRAs are now empowered to examine their workloads and provide evidence as to how efficiently they are managing their demand, capacity, service, and quality levels. By articulating the areas needing improvement in an evidence-based approach, CRAs can now suggest solutions that will allow them to assume greater control of their day-to-day functions and outcomes. Within the organization, the CRA then is better suited to move into a position of increased responsibility and compensation.
Increased skill development opportunities within the function. CROs typically assign CRAs across multiple sponsors, providing less depth of experience, whereas functional outsourcing providers assign the CRA across one sponsor's entire portfolio and therapeutic areas. This allows the CRA to become the functional expert for that sponsor, again positioning them for a higher level position in the future.
New skill sets for a new career alternative. Monitors working for functional outsourcing providers are typically expected to increase their competency with more advanced technological applications as well as the more sophisticated soft skills to influence site productivity mentioned earlier. Functional outsourcing providers are now making it possible for CRAs to gain fundamental operations management skills to enable them to examine the work flow and provide input as to how work is conducted, thereby influencing service and quality.
New Skill Sets for CRAs
Although many CRAs may already have a natural aptitude for organization, these skills can be honed through training. Leading outsourcing providers are now investing in their CRAs to develop and strengthen the operational skills needed to align with full site management and the Lean and Six Sigma principles. With these new skills, CRAs are empowered to make more day-to-day decisions, freeing team leaders to focus on quality oversight and continuous improvement. CRAs speak enthusiastically about the dramatic improvement in their work lives, the new found control they have, and their ability to influence study outcomes.
As for lifestyle issues, the extensive travel requirements and unbalanced workloads expected by the CRO have often resulted in CRA burnout and high turnover. Many CRAs cite lack of empowerment or ownership, as they are quickly shifted among sponsors, sites, and studies. Functional outsourcing firms, on the other hand, offer CRAs a number of lifestyle advantages:
Competitive compensation for experienced CRAs. Although leading functional outsourcing providers require CRAs to have at least 2 to 5 years of experience, they then offer compensation and stature commensurate with that level of experience. In fact, the trend toward increased industry outsourcing has created greater demand for qualified CRAs, prompting outsourcing providers to offer more competitive packages to top candidates, often comparable to those formerly available at the large pharmaceutical companies.
Quality of life. Work-life balance is still an important consideration in the decision to accept a position as a CRA. Candidates must weigh the amount of travel, pace of position, and advancement opportunities against their personal needs and goals. As pharmaceutical companies continue to progress from paper-based monitoring to greater reliance on electronic data capture (EDC), travel to sites will continue to decrease. CRAs will conduct more monitoring activities remotely, thereby eliminating the need for a great deal of travel.
Focus on relationship building. Functional outsourcing providers expect CRAs to operate on behalf of the sponsor, learning the sponsor's systems and processes, relating to study team members, becoming fully integrated into the team, and actually serving as the "face" of the sponsor. Effective CRA/team relationships should result in increased time, effort, and commitment on the part of the study team and therefore more productive clinical trial sites.
Experience with industry leaders. CRAs who had formerly hoped to spend the next stage of their careers with an industry leading pharmaceutical company now have another option. They can join an outsourcing provider with a strong record of clinical trial success and a reputation for industry leadership based on its operations management processes.
As demands from many directions have created changes in the process for development of pharmaceuticals, sponsor companies are recognizing the need for more innovative practices to allow them to get back to the basics of drug development. That refocus has spurred an even greater reliance on outsourcing providers for nonstrategic competencies such as monitoring.
With a shared reliance on operations management processes, sponsors and their functional outsourcing partners will benefit on a broad level, achieving higher quality, lower costs, improved customer satisfaction, streamlined processes, and a higher return on invested capital.
And on a personal level, individuals such as CRAs will gain more control of career development and work-life balance, improving technical, interpersonal, and management skills to enhance their personal development as well as their value to their employer.
Eleanore Doyle is the group vice president for Kforce Clinical Research, a division of Kforce Inc., 1001 E. Palm Avenue, Tampa, FL 33605, email: firstname.lastname@example.org