Quality Assurance & Audits

巧妇难为无米之炊

“Even a clever chef cannot cook a meal without rice”

– Song Lu You

Good Clinical Practice (GCP) is the universal ethical and scientific quality standard for conducting clinical trials. And as the NMPA takes steps to attract more foreign companies to conduct clinical trials in China – whether as part of a global study or as a China-only study – it has never been more important for local CROs to conform to global standards. Luckily for us at CSC, this is something we have incorporated in every aspect of our work since establishment.

Under GCP guidelines, quality is a continuum which begins with designing, is critical during conducting and recording, and continues during the reporting of trials. That is why our Quality Assurance department provides oversight of everything we do and is instrumental in the development and maintenance of our most fundamental pillars of quality – SOPs and Training.

At CSC we strongly believe that only by having quality at the very core of our processes can we ensure that data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected.

How we can help:

  1. In-house Audits
    • Trial Master File (TMF) Audits
    • Clinical Document Audits
    • Database and Statistical Analysis Audits
    • System/Process Audits
  2. Site Audits
    • Investigator Site Audits
    • On-Site Pre-Inspection Preparation Visit
    • On-Site Facilitation of Health Authority Inspections
  3. Third Party Audits

More About the Clinical Service Center CRO

OUR LEADERSHIP TEAM

Leadership

Our senior managers and executives were trained in the West, have worked for big Western pharmaceutical companies, and are committed to bringing the best clinical practices to China.

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OUR HISTORY

Company News

For more than a decade, Clinical Service Center-“CSC” (formerly Beijing Clinical Service Center – “BCSC”) has been conducting top-quality clinical trial services in China for pharmaceutical, biotech, and medical device companies the world over.

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FULL SERVICE PLUS

Full Service Plus

At CSC we define our business scope as “full-service plus” because we go above and beyond the requirements of a traditional full-service CRO to provide you with the end-to-end services you require to get your product in to the China market.

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