Healthcare Technology Featured Article

June 27, 2011

MCC's Network of Expert Medical Writers Helping Speed up FDA Approval Process for Pharmaceutical Industry


Cincinnati’s Medical Communication Consultants (MCC) announced that its Writers Initiative Network, launched last year, yielded great results, helping pharmaceutical companies save a lot of money and time. The initiative has been designed to link experienced medical writers with the right projects. MCC collaboratively manage the processes for its clients.

In the healthcare industry, medical writers perform an important task by speeding up the FDA approval process for pharmaceutical and medical technology companies. MCC’s expert medical writers are matched to each project and help increase the efficiency of the entire process.

MCC’s Writers Initiative Network (WIN) attracts more of the best medical writing specialists in the industry, MCC claimed in a press release. Its writers are either PhDs or have 10 years of experience in medical writing. According to the company, WIN now has 142 medical writers located throughout the U.S. to help drug companies fulfill Food and Drug Administration (FDA) regulations regarding new drug development and medical device approval. Last year the organization had 57 people within its operation. MCC claims to help the pharmaceutical companies cut the high cost of new drug development by taking advantage of technology and outsourcing trends. The president and founder, Keith Kleeman headed initiative translated into a great profit earner for the company, the company revealed in the release.

MCC reported 46 percent growth in 2009, and 20 percent growth in 2010. MCC has sustained average growth of 68 percent per year over the last five years.

According to Kleeman, using one large clinical research organization (CRO) as a sole source provider is not necessarily wise. WIN provides pharmaceutical companies access to the right medical writing specialists. Kleeman has developed a database of expert medical writers that documents each writer’s areas of expertise and number of projects written in those specific areas. MCC writers must pass a battery of writing and ethics tests before being accepted into the network.

MCC claims to have a higher client and employee retention rate than average U.S. clinical research organization that reports a problematic yearly turnover rate.  Kleeman claimed that he’s never lost a client and has lost only two writers.

The FDA requires patient narratives to be included in applications, and medical writers used to wait until testing was complete before writing them up. A recent project involved creation of an in-stream series of patient narratives during clinical trials.

Keith Kleeman was a finalist for the Cincinnati Business Courier Health Care Heroes awards in 2011.


Madhubanti Rudra is a contributing editor for HealthTechZone. To read more of her articles, please visit her columnist page.

Edited by Rich Steeves
Get stories like this delivered straight to your inbox. [Free eNews Subscription]




SHARE THIS ARTICLE



FREE eNewsletter

Click here to receive your targeted Healthcare Technology Community eNewsletter.
[Subscribe Now]