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Quality in a clinical trial is needed right from the moment we start jotting down our investigational plan, study objective and deciding end points to statistical analysis, data management, site monitoring and finally patient recruitment and close-out. Data is generated at each stage and is expected to be error free.

On the other hand, the users/patient(s) perceive quality a little differently. They look for accessibility and affordability of healthcare, promptness of delivery, early diagnosis and treatment, thereby ensuring their early return to productivity. They also wish to be treated with empathy, respect, and concern.

The Quality of clinical studies depends largely on data integrity and protection of the subject. To date, common quality issues are discovered during basic audits and inspections at a clinical study site or site monitoring activities, which is not enough in the current globalization scenario and complex requirements of any clinical study.

This whitepaper outlines the following key factors:

  • regulatory requirements
  • critical role of quality system in a clinical trial
  • building quality in clinical trials
  • common causes of poor clinical quality
  • strategies to assure quality in clinical data & processes, and
  • implementation of a risk based QMS

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