Clinical Research Consulting, Inc. Provides Clinical Research Monitoring Model That is Beneficial to Industry Sponsors

By Lisa Mazurka, President and Founder, Clinical Research Consulting, Inc.

Abstract
Numerous pharmaceutical and biotechnology organizations use contract research organizations (CROs) to outsource the service of monitoring clinical trials. Clinical Research Consulting, Inc. (CRCI) has a model that is unique than most industry CROs. Many CROs are finding this alternative approach beneficial and more cost effective.

This article will discuss the CRCI monitoring service model, what makes it unique and why it continues to grow amongst industry sponsors.

About the Author:
Lisa Mazurka is Founder and President of Clinical Research Consulting, Inc. (CRCI), a Contract Research Organization (CRO) specializing in clinical monitoring, project management, quality assurance & compliance auditing (QAC), training, and educational services.

Clinical Research Consulting, Inc. Provides Clinical Research Monitoring Model That is Beneficial to Industry Sponsors

Clinical Research Consulting, Inc. (CRCI) a contract research organization located in Boston, MA continues to attract pharmaceutical industry sponsors to its unique monitoring service model.

“Our model is unique and different from many CROs in the industry” states Lisa Mazurka, CRCI’s Founder and President. First, we hire and work with only the most seasoned clinical research professionals. We have a five year minimum experience requirement for all consultants working with our organization. This provides industry sponsors with monitors who are not only highly experienced but also have a vast range of areas of indications that they have previously worked with.  It makes our sponsors happy that they not only have seasoned professionals but experts in the field within the designated disease indication under research (i.e., prostate cancer, COPD, Alzheimer’s disease, etc.).”

In addition, CRCI’s model uses consultants versus full-time employees which has proven to be a better alternative for sponsors. “One of the frequent complaints we receive from sponsors who are shopping for new CRO monitoring resources is the frequent turnover they have experienced with other CROs. This high turnover may be caused by two sources states Ms. Mazurka; The large CRO CRAs tend to be overburdened with a large amount of work and this leads to burnout and job dissatisfaction and/or recruiters tend to recruit CRAs from CROs for other industry positions. “

In addition, recent increase in turnover rates for CRAs at CROs has been a result of the current state of the economy.  CROs are being forced to downsize as research projects are cut due to lack of funding and financial resources. An article posted on the web by Fierce Biotech on April 22, 2009 noted that the economic crisis has now spread to CROs.  Kendle International reported 2009 first quarter revenues far below the $121 million that Wall Street estimated¹. Further, the article notes that since the pharmaceutical/biotech industry does not normally have a lot of financial cushioning in its contracts and budgets, funding cuts go right to the bottom line forcing CROs to downsize their workforces to cut costs.

Because CRCI’s model is a consultant model, consultants are contracted and hired on an “as needed” basis. Consultants are also able to choose the projects that they find interesting and that fit into their current lifestyle (part-time/full-time). Consultants do not experience the high burnout of full-time employees because they are able to balance their life and work responsibilities as they see fit. In addition, because they are consultants, they are not recruited from job to job as employees and contribute to corporate turn over as is seen at other organizations.

“Our turn-over rate has been less that 10% over the past 11 years”, states Lisa Mazurka, president of CRCI. “For this reason and the others discussed in this article, we have seen a recent increase in our business over the past few years and are becoming a fresh alternative for industry sponsors.”

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References:

1. “As R&D Spend Drops, CROs Face Tough Times,” Fierce Biotech, April 22, 2009, M. Martino

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Lisa K. Mazurka is Founder and President of Clinical Research Consulting, Inc., a niche Contract Research Organization (CRO) which provides clinical monitoring, project management, quality assurance and compliance (QAC) audits, education and training services to the clinical research industry. Ms. Mazurka has been instrumental in the development of CRCI’s unique monitoring service model and continues to market the service as an alternative for the clinical research industry.