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Would you place your full trust in a healthcare provider that kept your medical records in spreadsheets or paper files? Not likely. But every day, one of our most valued business assets – biospecimen and related patient consent data – is placed into systems that are just as primitive.  In the era of “big data” and deep analysis, why do companies continue to manage this critical data in spreadsheets, rudimentary tracking tools and isolated laboratory information management systems (LIMS)? When it comes to managing biospecimens and associated patient consent, there is a tendency to be short-sighted. The focus is on using "Band-Aids" to get through the current study, at the risk of lost... Read More

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Analytics , Central Laboratories , Companion Diagnostics , Data Integration , Technology , Precision Medicine , Translational Medicine

On Monday 21st May 2018 the US FDA published the final version of the updated Bioanalytical Method Validation (BMV) Guidance for Industry. Considering this is a pivotal guidance for conducting regulated bioanalysis, a finalized document was highly anticipated since the release of the draft version in 2013. As such, I thought I’d summarize my personal first impressions and anticipate how our community may respond and adapt. My intent is only to spur further discussion and dialogue on this important bioanalytical milestone. I don’t doubt that more substantive review and discussion from across the bioanalytical community will follow and I’ll look to delve deeper myself into the pertinent... Read More

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Bioanalytical Laboratories

Author: Costa Panagos During April 22-28, 2018, Q2 Solutions is celebrating Medical Laboratory Professionals Week, also known as Lab Week. I want to take this opportunity to acknowledge and thank our global laboratory teams for their important work and ongoing commitment to serving our patients, customers, and each other. When I first joined Q2 Solutions and toured our various sites, I noticed an inspirational sign posted in one of our laboratories. It read, “Every laboratory sample we process impacts a patient’s life. Your handling and subsequent analysis provides the essential information used to diagnose and determine treatment options.” This sign had a profound impact on me that I... Read More

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ADME , Analytics , Assay Development , Biomarkers , Central Laboratories , Companion Diagnostics , Data Integration , End-to-End Services , Genomics , Immunoassay Services , Precision Medicine , Research and Development , Translational Medicine , Vaccines