FEATURED ARTICLES

How Do I Get My Compound Into Phase I?

The primary challenge for pharmaceutical and biotechnology companies in developing their drugs is to carefully assess the relationship between efficacy and toxicity prior to entering into human clinical trials. By Dr. Scott E. Boley and Greg Ruppert

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WHITE PAPERS & CASE STUDIES

  • Accelerating Preclinical Studies With Project Tracking And Optimization Software

    A large pharmaceutical company with globally distributed preclinical R&D operations including externalized services implemented an advanced assay/ study tracking and optimization system in conjunction with its enterprise electronic lab notebook.

  • 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.
  • White Paper: Understanding the 505(b)(2) Approval Pathway

    Explore how the 505(b)(2) regulatory pathway can help drug developers gain approval for new drugs in a fraction of the time and cost required by traditional paths.

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SERVICES & PRODUCTS

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Medical Writing Services

Documenting your clinical trials in the most effective way is critical to getting your product to market. We can help you write a wide array of documents to support your clinical research at any point in development, including.

Pediatrics
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.
Model Based Drug Development
Turning healthy ideas into healthy humans has become a complex equation in the face of spiraling costs and rising scrutiny.
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