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Jenny Zhang | February 24, 2017

Delivering Excellence in China

Our commitment to providing accurate, quality data in China 
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 Of those 1600+ drug applications approximately 1,100 applications were voluntarily withdrawn.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 the safety and effectiveness for the drug in application), and, most alarmingly, some were for untruthful data, part of which included the possibility of deliberate data fraud1

CFDA director Bi Jingquan has identified falsified clinical data as a "cancer" on Chinese based drug development that could weaken the credibility of the Chinese drug industry2.  We at Q2 Solutions couldn’t agree more.

Ensuring data integrity to improve patient safety

As a clinical lab services provider with over 30+ years of experience we understand the importance of accurate, high quality data to support the development of life changing medications in China and around the globe. Up to 80 percent of the clinical trial data needed to support a new drug application comes from the lab, providing the bedrock for certain new drug applications3.  We are keenly aware of our responsibility to the CFDA, our customers, and more importantly the patient population at large.  

Q2 Solutions has the largest network of wholly owned, CAP-accredited central laboratories including a new facility in Beijing China. At Q2 Solutions we have made significant investments in people, process, and technology to ensure we are proving high quality, reliable data. Our Beijing lab passed a US FDA inspection in March of 2016 with no findings, and over the past two years we have had more than 10 CFDA inspections with no major findings.  Our lab in Beijing abides by all CGLP practices and is ISO 15189 accredited.

As Q2 Solutions continues to partner with both local Chinese organizations and international organizations conducting trials locally, we are investing heavily in quality systems and infrastructure to maintain superior delivery.  We operate a Quality Management System (QMS) that has established a culture of continuous improvement and personal accountability, keeping the patient at the center of all we do.  Our QMS includes industry regulatory requirements and accreditations such as Good Clinical Practice (GCP), Good Laboratory Practice (GLP), CLIA/CAP, and ISO15189. The QMS helps evaluate adherence to quality standards and ethical behavior, maintain Corrective and Preventive Actions (CAPA) compliance control, and apply lessons learned globally to our local lab in China.

Q2 Solutions recently relocated our Beijing lab to a new, modern laboratory facility.  This new facility allows us to expand our overall testing capabilities and to institute quality enhancing practices – including improvements to samples receiving, sample flow through, and physical segmentation of key testing procedures.   These enhancements allow us to avoid testing errors and improve the overall quality and accuracy of the final results and subsequent data.  Accurate, reliable data is critical to maintaining patient safety during a trial and establishing a product’s potential benefit to the larger intended use patient population. Although hearing of such data discrepancies can be frightening, we have deep admiration for the CFDA and their transparent approach to self-examination and verification. As clinical trials become even more complex, the need for strong clinical data will only grow. Q2 Solutions is fully invested in the continued improvements the CFDA is instituting to support the development of new medicines in China. 

References:
  1. The China Food and Drug Administration (CFDA). Interview with Official from the Department of Drug and Cosmetics Registration of CFDA about the Verification of New Drug Clinical Trial Data. http://eng.sfda.gov.cn/WS03/CL0757/165480.html 
  2. Fierce Pharma.  http://www.fiercepharma.com/regulatory/cfda-head-says-clinical-trial-problems-a-cancer-on-industry
  3. Applied Clinical Trials.  http://www.appliedclinicaltrialsonline.com/medical-imaging-core-laboratories