Gastrointestinal Services & Products
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Gastroentrology
6/24/2011
Gastroentrology
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Internal Medicine
5/20/2011
Clinical trial design, site selection, enrollment speed, regulatory hurdles, market access challenges, and commercial adoption are just some of the challenges that must be overcome to achieve success for a product development program.
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Medical Writing
Writers with both industry and therapeutic expertise
Each member of our core regulatory and medical writing team draws on extensive industry knowledge and therapeutic expertise to effectively meet our clients’ product development requirements and provide top notch medical writing services. Each writer is a graduate-level life science scholar. They enhance their scientific and technical expertise through continuing medical education and study-specific training. Our writers also have access to internal therapeutic experts, researchers, and academics to gain sophisticated insight across many therapeutic specialties. Their experience and training enable them to expertly prepare reports in accordance with regional regulations and ICH Guidelines and to create clinical trial and regulatory documentation suitable for submission to regulatory authorities, including FDA and EMA.