Taking a candidate drug to market – and to the patients who will benefit from it – requires supporting data from high-volume, regulated clinical studies. From sample receipt to final reporting, Q2 Solutions understands the importance of delivering qualified clinical sample data throughout all stages of the drug development cycle.
Q2 Solutions’ bioanalytical experts can partner with you to develop biomarker assays and cell-based bioanalytical assays that incorporate state-of-the-art instrumentation, rigorous quality control, and a logistics infrastructure to support large-scale, international studies.
Q2 Solutions can support your large-scale clinical projects by leveraging:
Q² Solutions provided bioanalytical support for two randomized, double-blind, Phase III studies to assess the long-term safety and efficacy of various dosing regimens of a novel new drug and a comparator drug in targeted patient population groups. Over a four-year period, Q² Solutions assayed the pharmacokinetic profile of the compound and its major metabolite in plasma. Collectively, these studies required the analysis of over 50,300 samples (including placebos) from more than 29,000 subjects. For the larger study, samples were provided by nearly 1,400 centers located in 46 countries. A final bioanalytical report of over 8,000 pages was written in five weeks to meet an aggressive regulatory submission date. Results from these multi-institutional studies ultimately supported the U.S. Food and Drug Administration’s approval of the drug.
— Q² Solutions
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