White Papers

  1. Considerations For Pursuing Accelerated Approval In Oncology Indications

    For many years, sponsors in the US have been able to apply for Accelerated Approval from regulators based on a surrogate endpoint. This approach is intended to speed products to market that treat serious or life-threatening conditions and that offer a benefit over current treatments.

  2. Successfully Manage The Unique Demands Of Cell Therapy Supply Chains

    The complexity associated with manufacturing a ‘living drug’ should not be underestimated and it is important to consider that each product will have its own specific challenges and complexities.

  3. Clinical Supply Chain Forecasting And Simulation

    Accurate forecasting of clinical supplies has become increasingly important in the past several years as planning the amount of study drug and other materials required to complete a trial has grown in complexity.

  4. Special Handling Required: Considering The Clinical Supply Chain In Vaccine Trials

    Vaccines, one of the most useful and cost-effective means of reducing illness and death from infectious diseases, are enjoying a resurgence of interest that some have pronounced a renaissance. With hundreds of vaccines in research and development worldwide, vaccines are among the fastest growing segments of the biopharmaceutical market today.

  5. Top 10 Questions To Ask Your Clinical Supply Vendor About Temperature Sensitive Drugs

    Over the years, an entire system called ‘cold chain supply (or cold chain transport)’ has developed in the food industry to ensure that foods that need to be kept cold are stored and transported in appropriate conditions and are monitored so consumers and regulators can be assured of their safety.

  6. Improved Data Quality & Integrity For Faster Regulatory Approvals

    A study examining all new molecular entity (NME) applications first submitted to the FDA between 2000 and 2012 found that several potentially preventable deficiencies account for significant delays in the approval of new drugs.

  7. Social Media For Patient Recruitment

    The phenomenal growth and utilization of online social networks has created a range of new opportunities for recruiting patients into clinical trials. From Facebook to Snapchat and Bebo to hi5, social networks offer sponsors a channel through which they can proactively and cost-effectively place trial information directly in front of potential participants.

  8. Debunking Top 10 Myths In Clinical Trial Enrollment

    Patient enrollment is still a relatively nascent industry, all things considered. Therefore, it is not surprising that trial sponsors are struggling to separate fact from fiction when it comes to evaluating the pros and cons of seeking patient enrollment support. Take a look at some of the common industry myths, and why they need to be debunked here and now.

  9. 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.

  10. 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.