White Papers

  1. Patient & Data Security In Clinical Trial Enrollment

    The threats to patient data are increasing, and increasingly public. They typically do not come from some nefarious hackers, either. Rather, security breaches are usually the result of human error.

  2. Predictive Modeling In Clinical Trial Enrollment

    Predictive modeling plays a critical role in successful clinical trial recruitment planning and completion. Using predictive modeling, clinical study teams can estimate the time needed to recruit the required number of enrolled subjects using a set number of sites.

  3. Considerations For Clinical Trial Patient Engagement And Retention

    Keeping patients in clinical trials, always recognized as a need among sponsors, has historically been addressed with chotchkies and patient offerings like “frequent flyer” programs, thank you notes, and teddy bears. Recently, however, the continuing decline in retention rates is emerging as a much more widely recognized and deepening concern, transforming retention from luxury to necessity.

  4. Preventing Unintentional Unblinding In Clinical Trials

    It’s well known that clinical trials have become increasingly complex and costly over the past few decades.

  5. Cost-Effective Trial Supply Management (TSM) Using Interactive Response Technology (IRT) And Integrated Forecasting

    Managing clinical supplies effectively and efficiently requires a skillful blend of art and science to balance dozens of variables and considerations in order to create a fully optimized supply chain strategy.

  6. Executing Trials For Proposed Biosimilars: Challenges And Best Practices

    In this paper, we discuss how executing Phase III trials for biosimilars differs from that of New Chemical Entities (NCEs). Sponsors should understand from the outset that they will need to build in additional planning time and adopt tailored strategies for assessing feasibility, selecting sites, recruiting patients, procuring the comparator product, and ensuring the integrity of the study blind.

  7. Strategies For Biosimilars Development

    The U.S. biopharmaceutical market recently experienced a watershed moment: a 21-3 Advisory Committee vote in February 2016 to approve the first monoclonal antibody biosimilar. CT-P13, Celltrion’s biosimilar to Remicade® (infliximab), targets autoimmune diseases, including Crohn’s disease, ulcerative colitis and rheumatoid arthritis.

  8. A Sleeping Giant No More: Opportunities & Challenges For Clinical Research In China

    This paper examines the opportunities and challenges of conducting clinical trials in China, and offers proven strategies for overcoming hurdles.

  9. A Brief Synopsis Of Modern Randomization Methodologies And Technologies

    Randomized, double-blind clinical trials are the gold standard for adequate and well-controlled studies in modern times. However, prior to the late 1940s, randomization and blinding were not used in medicine and as result, bias was common.

  10. Beyond Procurement: Taking A Strategic Approach To Comparator Drug Sourcing

    Read our whitepaper on comparator drug, the mistakes companies make and tips for getting the best deal on sourcing.