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. An industry in transition
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.
CRA career progression
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:
