Get Clinical Research Answers Faster with Fit-for-Purpose Bioanalytical Method Validation

By Edward Wells,

  While most bioanalytical assay characterization that takes place at Worldwide Clinical Trials involves fully validated methods, we’ve seen a rise in the popularity of an alternative approach in recent years. In a Worldwide Clinical Trials webinar about clinical trial design, Steve Unger, Senior VP of Bioanalysis, described the “fit-for-purpose assay” as an innovative way to answer questions earlier in clinical trial development, and often in a more cost effective manner than with fully validated methods. Whether you call it fit-for-purpose, tiered assays, scientific validation, qualified assays or partial validation, this flexible approach to bioanalytical method validation is a necessary component of current drug development programs. 

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Q&A with Barbara Zupancic: How to Retain Patients in Cardiovascular (CV) Clinical Trials

By Barbara Zupancic, Director of Global Patient Recruitment and Retention,

In a January 2017 blog post, we noted that large international cardiovascular (CV) clinical trials are a better way to assess potential new treatments across many countries versus the alternative of separate smaller trials in each region. One of the more pressing challenges for clinical operations professionals who run these large trials is how to ensure patients who initially enroll in the studies continue to participate over the long term. For insights into how to retain patients in large outcome cardiovascular clinical trials, Talking Trials spoke with Worldwide’s Barbara Zupancic, Director, Global Patient Recruitment and Retention.

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Parkinson’s Disease Research: Biomarkers May Improve Frequency of Early Diagnosis – Part 1

By Tomislav Babic MD, PhD,

In many neurodegenerative diseases, the search for biomarkers has been driven by an extensive investigation and characterisation of the disease itself, as well as diseased tissue. Due to the examination of post-mortem brain tissue in Parkinson’s disease (PD) research, relevant molecular pathways and genes that have allowed for targeted therapies, development of animal models, and new drug delivery systems have been identified.

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Exploring the Future of Clinical Research for Immune-Mediated Inflammatory Diseases (IMID)

By Ian Braithwaite, Vice President, Global Project Management, IMID Franchise, Global Clinical Operations at Worldwide Clinical Trials and Anna La Noce, M.D., Executive Director, IMID Franchise, Medical & Scientific Affairs at Worldwide Clinical Trials,

  Significant and ongoing research into immune-mediated inflammatory diseases (IMID) such as multiple sclerosis, psoriasis, pulmonary fibrosis and asthma, has led to the knowledge that underpinning these diseases is the dysregulation of the immune system, which leads to widespread and chronic inflammation. Seemingly unrelated inflammatory disorders are now known to share common pathways of immune mediation. While the exact identity of the inflammatory stimulus is often unknown, genetic linkages across indications continue to emerge. These discoveries have delivered a more comprehensive understanding of immune-mediated mechanisms, and the promise for more effective treatments and possibly even cures for a range of IMID diseases. Of course, like other therapeutic areas, IMID studies present a number of unique challenges for researchers including site and patient recruitment, and difficulty in complying with standardized protocols.

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