Insights On Trial Design

  1. RFID: The Cure For The Clinical Trial Blues

    RFID is making its way into more and more industries as the technology matures and enterprises discover new use cases with solid ROIs. With a strong customer base in the life sciences sector, we see new markets developing rapidly for the technology. By Joe Pleshek, President & CEO

  2. Improve Accuracy And Efficiency In Data Collection For Mental-Health Evaluations And Assessments

    MedAvante is a global provider of centralized, expert psychological rating services to the pharmaceutical, biotechnology, and medical device industries.

  3. End-To-End Management Of Clinical Trials Data

    The introduction of electronic data capture (EDC) systems in clinical trial data management and analysis triggered the promise of better-managed clinical trials – with greater efficiency, faster access to higher-quality clinical data and better mapping of data flows to business processes.

  4. Marken Delivers In Spite Of A Dry Ice Disruption In Moscow

    In August of 2010, both dry ice factories in Moscow, Russia were shut down for an unplanned technical upgrade. At the same time the weather in the region was unusually hot (40°C, 104°F) which placed a higher than normal demand for dry ice to keep frozen shipments within the required temperature range.

  5. Importance Of Preclinical Imaging In Drug Discovery

    The process of discovering and bringing a drug to market consists of several stages, beginning with identification and validation of a drug target and continuing through lead identification by high-throughput screening, lead optimization, and profiling in relevant disease models.

  6. Moving Towards An Electronic Environment In Clinical Trials

    With each passing year, clinical trials are becoming increasingly global. The business of product development is moving away from the traditional model in which studies are conducted primarily in the US – in fact, recent estimates indicate that within the next three years, up to 65 per cent of studies under FDA regulation will be conducted outside the US. A review of a US government clinical trials registry and of 300 published reports in major medical journals revealed that one third (157 of 509) of Phase III trials were being conducted entirely outside the US, with over half the study sites (13,521 of 24,206) used in these trials located overseas, many in eastern Europe and Asia.

  7. Overcoming Clinical Challenges In Metabolic And Cardiovascular Disease With Metabolomics

    Metabolic diseases (e.g. obesity, type 2 diabetes, and hypertension) are a rapidly expanding health care concern. Although there is a high demand for novel therapies, the challenges are substantial as existing drugs typically fail due to lack of efficacy or safety, and clinical studies often extremely large and protracted. 

  8. Overcoming Clinical Challenges In Oncology With Metabolomics

    Cancer continues to be a formidable disease with an overall success rate of bringing new drugs to market of only 5-8%.

  9. 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

  10. Streamline And Accelerate A Drug Development Plan Using The 505(b)(2) Pathway

    An international pharmaceutical company approached Camargo Pharmaceutical Services to help navigate the Food and Drug Administration (FDA) 505(b)(2) approval pathway for a promising drug under development designated for patients with cardiovascular disease. Product X is a prodrug that is converted in one metabolism-dependent step to produce the active metabolite of an approved drug.