FEATURED ARTICLES

Toxicometabolomics For Compound Attrition To Reduce Late Stage Failures Due To Safety

Many ’omics’ technologies have now become the primary way of discovering new biomarkers, and validation of these biomarkers is a relatively new and evolving concept. By Michael V. Milburn, John A. Ryals, and Lining Guo

WHITE PAPERS & CASE STUDIES

  • Brochure: Norwich Clinical Services

    Norwich Clinical Services is a contract research organization that provides Bioanalytical Services, Pharmacovigilance and Clinical Research Programs to the pharmaceutical and biotech industries.

  • Ethnic Bridging

    Clinilabs, a contract research organization (CRO), was selected to characterize the pharmacokinetic prole of XXXX following the administration of four doses of XXXX to healthy Japanese and non-Japanese subjects aged 20 to 45 years by assessing serum concentration data over time.

  • Clinical Trials In Russia The Federal Service on Surveillance in Healthcare and Social Development of the Russian Federation (Roszdravnadzor) and the Ministry of Health and Social Development of the Russian Federation (MoH) approved 492 new clinical trials of all types including local and bioequivalence studies during 2010, demonstrating a 15% decrease from the last year figure.
  • White Paper: Foreign Clinical Trial Data Given the high cost of moving a promising drug candidate through years of clinical trials, it’s no wonder that more and more drug manufacturers have begun conducting at least some of their clinical trials in foreign countries. With lower costs and shorter recruiting times, the use of foreign sites is appealing to all drug developers, but especially to those involved in generic and “fast-track” approval programs.

SERVICES & PRODUCTS

Located on the campus of Cauvery Medical Centre in Bangalore, India, the 72-bed clinical facility contains separate areas for subject screening and blood draws, an on-site pharmacy and a state-of-the-art, fully equipped intensive care unit.
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Deep therapeutic knowledge and understanding of the key issues combined with clinical development experience drives more effective and efficient pathways to commercialization.

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The current regulatory climate, and the need to meet Food and Drug Administration (FDA) and European Medicines Agency (EMEA) pediatric regulations, has increased the burden on manufacturers.
Turning healthy ideas into healthy humans has become a complex equation in the face of spiraling costs and rising scrutiny.

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