EDITOR'S DESK

Clinical News Roundup: Will Changes To EU Legislation Improve Trials?
Clinical News Roundup: Will Changes To EU Legislation Improve Trials?

Clinical news roundup for the week of May 22, 2016 with articles on EU legislation, five major trials set to announce results, BIO releases study on clinical success, trials in Australia, fear as a roadblock to oncology recruitment, and more.

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  • Clinical Supplies For Biosimilar Trials – What To Consider
    Clinical Supplies For Biosimilar Trials – What To Consider

    A quick glance at the pharmaceutical industry news may indicate the golden age of biosimilars is just around the corner.  Approved biosimilars could account for more than $20 billion in revenue and save EU and U.S. health systems more than $56 billion by the end of 2020, two recent reports concluded.

  • Preventing Unintentional Unblinding
    Preventing Unintentional Unblinding

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

  • Making Site Selection Precise And Accurate
    Making Site Selection Precise And Accurate

    Underperforming investigative sites have long been a puzzling issue for clinical trial stakeholders. There are lots of reasons for sub-optimal performance, ranging from inadequate processes for study execution to overly complex protocols.

  • Developing Immunotherapies For Cell-Based Vs. Non Cell-Based Therapies
    Developing Immunotherapies For Cell-Based Vs. Non Cell-Based Therapies

    Immunotherapies harness the power of the body’s own defense mechanism, the immune system, to combat disease. They were initially introduced in the form of non cell-based biologics and vaccines, such as the splurge of products known as the check-point inhibitors designed to target the PD1/PD-L1 immune pathway. An individual would be injected with a weakened form of a virus, exposing the body to the disease and prompting the immune system to produce antibodies to fight the infection from the live virus.

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

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FDA's New Guidance on Comparability Protocols: What You Need to Know June 7, 2016
1pm-2:30pm EDT, Online Training
Price:  $299 - Includes Bonus Handouts!
Adverse Event Reporting: Avoiding Common Pitfalls June 8, 2016
1pm-2:30pm EDT, Online Training
Price:  $299 - Includes Bonus Handouts!
Best Practices in CMC Dossier Preparation – Facing Tough Challenges June 9, 2016
Special Time for EU and US Participants - 10:30am-12pm EDT, Online Training
Price:  $299 - Includes Bonus Handouts!
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