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How Do I Get My Compound Into Phase I?
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 505(b)(2) is a new drug application which gains 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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SGS provides an extensive pharmacokinetic (PK) and pharmacodynamic (PD) support in pre-clinical and Phase I-III clinical studies in accordance with international regulatory standards (FDA, EMEA, ICH).
Early Phase
With a full scope of services from First in Human through Proof of Concept, PAREXEL's early phase operational teams are right where you need us.
Clinical Services Clinical Services

In today’s pressure-filled biopharmaceutical development environment, no company can afford to spend the $800M or more it takes to bring a product from the lab to the marketplace, only to have it fail in critical Phase III clinical trials.

Phase I Services Phase I Services
For the early stages of drug development, Rho provides packages for Phase I clinical trials that have predictable cost structures.
Therapeutic Areas Therapeutic Areas
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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