Covance Becomes First Major Central Laboratory in Japan to Add Anatomic Pathology and Histology Services

In an effort to help clients get faster clinical trial results and support development of today’s novel therapies, Covance recently expanded its Asia-Pacific footprint by becoming the first major central laboratory in Japan to add anatomic pathology and histology (APH) services at its Kawagoe facility. Learn more about how this …

Closing the Knowledge Gap with Real-World Evidence (RWE) Studies: The Importance of Starting Early

Successfully demonstrating product safety and efficacy in a randomized clinical trial is a monumental event, but it doesn’t always translate to market access and uptake one it’s launched. Since clinical trials are limited to a controlled sub-set of patients, observations recorded in the clinical trial setting can vary from what …

Brexit: Leveraging the Mutual Recognition Agreement to Mitigate Potential Risk With Commercial Drug Product Release Testing

The Brexit1 deadline has been extended once again – now to January 31, 2020 – and a withdrawal deal seems likely given the result of the December 12 general election. However, drug manufacturers and contract test laboratories should be proactive in understanding the potential regulatory considerations relating to commercial drug product …

Listening To – and Learning From – the Voice of the Patient

Patient recruitment represents the biggest challenge in clinical trials. From general patient identification and participation to reducing screen failure rate or limiting patient drop out after enrollment, drug developers face many massive pain points to initiate their clinical trials.   Patient recruitment and retention continue to be the biggest challenge in …

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Impact to the Bioanalytical Community of the FDA Issuance of the Draft Guidance on Biomarker Qualification: Evidentiary Framework

The FDA released a Draft Guidance in December (2018) on the evidentiary framework and standards required to achieve qualified biomarkers.  It is intended to cover a regulatory gap related to the use of biomarkers outside of specific drug programs.  As such, this Draft Guidance supports the Qualification of Drug Development Tools …

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Inflammatory Bowel Disease Clinical Studies – Where Do We Go From Here?

Inflammatory bowel disease (IBD), incorporating Crohn’s disease (CD) and ulcerative colitis (UC), is a chronic relapsing-remitting inflammatory disorder of the gastrointestinal tract.1 There is currently no cure for IBD and available treatments (e.g. aminosalicylates, immunosuppressant, biologics) have variable degrees of efficacy and tolerance. As a consequence, there is a large …

Building Awareness with National Diabetes Month and New T2DM Treatment Guidelines

Coinciding with National Diabetes Month is the recent publication, Management of Hyperglycemia in Type 2 Diabetes, 2018. A Consensus Report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD), which contains the most up-to-date, impactful set of new treatment guidelines for patients with …