Writers Initiative Network's outsourced medical writers aim to cut new drug development costs

Keith Kleeman's Writer's Initiative Network (or WIN) is on the fast-track to growth with an innovative approach to outsourced medical writing that aims to help drug companies fulfill FDA regulations regarding new drug development and approval.

The Writer's Initiative Network is part of Kleeman's six-year-old Medical Communication Consultants company.  Based in Mt. Lookout, where Kleeman also lives, the company provides a wide variety of contract writing services for medical and pharmaceutical clients. MCC relies on a network of highly educated, experienced writers with medical backgrounds who work with medical companies to write clinical reports, patent narratives, risk benefit analysis and much more.

WIN is an outgrowth of his company specifically aimed at the drug development and approval process. Unveiled before the American Medical Writer's Association last fall, WIN is believed to be the industry's first creative resource organization of expert medical writers who are assigned to specific drug development projects based on experience and drug or medical device expertise.

"There's not another company in U.S. that has the software in place we have set up to take advantage of the pool of talent out there, and to retain affordability," said Kleeman.  Kleeman, a Cincinnati native with a background in medical writing, worked at Eli Lilly before returning to the Queen City to start his own company.

WIN currently employees 106 medical writers across the country. Kleeman believes his model, which keeps overhead low and matches writers to projects based on their specific backgrounds and specialties, is the wave of the future in outsourced medical writing. The company's revenue grew 46 percent in 2009.

WIN's writers go through a rigorous testing system before being hired. They must have an advanced degree and a minimum of three years' clinical regulatory experience. They undergo written exams and personal interviews assuring the writer is competent for this highly technical work.

Kleeman said unlike similar companies that have a smaller group of full-time writers WIN's writers are matched with outside companies based on expertise, not availability.

"That is a huge difference in maintaining affordability and flexibility," he said.

He maintains the writer's ability to quickly and efficiently work on everything from pre-clinical to marketing trails can shave month's off the drug development process, saving a company up to $100 million in development costs.

Writer: Feoshia Henderson
Source: Keith Kleeman, Medical Communication Consultants founder

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