Insights On Trial Design

  1. Full Service Management Of A Complex Global Multi-Phase Diabetic Macular Edema Study

    An adaptive design protocol incorporating an open label dose-escalation range-finding Phase I portion to confirm comparative dosing for the the multi-arm Phase II portion with combination and monotherapy treatment regimens for DME.

  2. Prevent The Unnecessary Costs of Patient Dropout and Noncompliance - Infographic

    This infographic provides industry-accepted figures of the cost of patient recruitment and how preventative measures can outset at a fraction of the cost.

  3. On-Site Manufacturing In Early Clinical Drug Development (In Europe)

    Early drug development requires adherence to Good Manufacturing Practices (GMP) guidelines when manufacturing investigational medicinal products (IMPs) for clinical studies conducted within Europe.

  4. Dermal Toxicology: A Multifaceted Approach To Meet Today’s Research Needs

    Developing a dermal NCE generally follows the same path as other small molecule NCEs administered orally or systemically, except that the dermal route is used in a non-rodent model.

  5. Top Clinical Research Trends of 2014

    2014 was a fast moving, controversial year for the clinical research industry. With so many choices it is hard to provide a complete summary of all of the events or developments over the past year but presented in this white paper is a listing of key topics from 2014. By Dr. Bill Gluck, Vice President Clinical Knowledge, DATATRAK

  6. Clinical Operations Cost Variation: Oncology vs. Non–Oncology

    The number of products in pipeline within Oncology therapeutic area was 3436 in 2013, which contributes to more than 29% of the total R&D projects.1 Cancer related cases are also estimated to rise up to 22 million within the next two years.2 Keeping these statistics in mind, pharmaceutical companies have earmarked a major proportion of their R&D investment on cancer related research.

    With more oncology clinical trials in the pipeline of most large pharma, there is question of why the operating cost for Oncology trials are higher than that of other therapeutic areas. Let us take a detailed look into this question.

  7. Despite An Airport Strike, Marken Preserves The Data Chain

    Marken collected a shipment from southern Sweden that was bound for next-day delivery in northern Belgium. However, all airline flights into Belgium were cancelled as a result of a strike action by airport workers.

  8. 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

  9. Catching Up With The Consumerization Of Technology In The Clinical Trial World

    Not too long ago, a clinical operations professional likely enjoyed more powerful technology capabilities at the office than at home. She had a sophisticated email infrastructure, shared calendaring, a high-speed network and maybe a Blackberry.

    At some point during the last 15 years this trend flipped. Suddenly people had better tools in their personal lives and the limitations of their office tools became apparent by comparison – for example, systems that won’t talk to each other, small inbox quotas, file size attachment restrictions, slow email searches and difficult file sharing. Meanwhile, consumer technology rapidly became more sophisticated, available and accessible with collaborative cloud-based tools, personal devices and similar applications to improve the efficiency of everyday tasks.

  10. International Clinical Trials In Serbia: Why Not Enroll The Right Patients Fast?

    It would be fair to say that applying the principles of evidence-based medicine and more stringent requirements of regulatory authorities (among which the FDA is first and foremost) to prove the efficacy and safety of newly developed drugs leads to the stable and steady growth of the number of clinical trials. It would be good to mention here that in the last 5 years clinical trials involved approximately 50,000 sites across the globe annually enrolling 1.5 million patients each year. At the same time, it is obvious that such a number of patients may not be enrolled by the United States alone, this country currently enrolling only about half this number, and that drug developers and Clinical Research Organizations (CROs) are constantly in need of finding new clinical sites outside the US borders where studies may be conducted in adherence to the proper safety requirements, where treatment standards are high and sufficient public control of the clinical trials may be ensured.