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In 2015 the China Food and Drug Administration (CFDA) ordered companies responsible for 1600+ new drug applications in China to conduct a “self-examination on the authenticity, integrity and compliance of clinical trial data”. Of those 1600+ drug applications approximately 1,100 applications were voluntarily withdrawn. From a recent interview conducted with an official from the department of drug and cosmetics registration of CFDA, it was learned that some of the data were for nonconformance to the Good Clinical Practices (which could affect the accuracy of the clinical trial results), some were for data incompleteness (which could not be traced back, and were insufficient to demonstrate... Read More

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End-to-End Services

The theme for this year’s World Cancer Day highlights the part we can all play in the fight against cancer.  “We can. I can.” is a call to action for individuals and groups to contribute what they can, either through dedicating their career to finding a cure or through single acts of kindness and support for a loved one with cancer. No single person or single organization can fight the fight alone, but together we can. Q2 Solutions supports the battle against cancer by offering a number of services to support clinical trials. These offerings include cutting edge genomics technologies to power and enhance immuno- oncology (IO) trials where reporting transcriptional response pairs a person... Read More

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Genomics

Researchers, healthcare providers, patients, families and friends join together on World Cancer Day to reaffirm our commitment to a unified fight against a disease that affects billions of people across the globe. Whether it be the patient who joins a clinical study, the friend or coworker that makes a charitable donation, the medical student who decides to specialize in oncology, or the company that commits to invest in the development of a new therapy, we all contribute how and where we can, according to our abilities and resources. At Q2 Solutions, we are helping develop and use biomarkers in oncology trials across the development spectrum.  Cancer trials increasingly rely on biomarkers... Read More

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Biomarkers , End-to-End Services