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International Clinical Trials

Cutting Back

 

The golden age of the pharmaceutical industry in which pipelines were full and cash cows were ample seems to be fading away. Pipelines are getting thinner and patent time is quickly running out on existing revenue-generating products. To keep the pharmaceutical industry viable, innovative solutions are needed to cut back on the time and costs of clinical development.

The first cuts began about 15 years ago, when the industry realised that the consecutive phases of clinical development could be run in parallel. Twenty years ago, Phase I studies were generally run before Phase II studies, which in turn were completed before Phase III studies. Now, outside of the initial first-in-man and perhaps a Phase IIa dose-finding study, most Phase I studies are run alongside the Phase II and Phase III programme. But that was only the beginning. The pressure to compress clinical development time continues to grow, and managers are trying to find ways to shorten the time to get their products to market.


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After receiving her PhD in developmental neurobiology, Julia Forjanic Klapproth started her career as a Medical Writer in the pharmaceutical industry at Hoechst Marion Roussel (later Aventis) in 1997. Since then she has been President of the European Medical Writers Association (EMWA) twice (2001-2002, 2007-2009). Julia is also an experienced trainer of medical writers, regularly running workshops for EMWA and pharmaceutical companies around the world. In 2002, Julia co-founded Trilogy Writing & Consulting, a company specialised in providing medical writing. In addition to company management activities as Senior Partner and CEO, she continues to contribute her enthusiasm to client projects, writing a wide array of clinical documents. Numerous clients have depended on and appreciated her expertise in writing and coordinating study protocols, study reports, and CTD submission dossiers.
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Julia Forjanic Klapproth
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