Quality Assurance

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Quality Assurance

Our QA Team provides the following services in compliance with ISO 9001:2015 and GCP.
In particular, independent GCP audits are the primary procedure for identifying, yet improving the quality of clinical trials. The GCP audits make sure that the clinical trials are in compliant with the applicable regulations, SOPs, and protocol. Through audits, our QA team identifies the risk factors and provides solutions to minimize the potential risk of the clinical trial.
Our Services :

Project Audits

  1. 1Investigator files/site audits
  2. 2Trial Master File audits
  3. 3Database audits
  4. 4Statistical report audits
  5. 5Clinical Study Report audits
  6. 6Regulatory submission audits
  7. 7Process audits
  8. 8Vendor audits

Additional Services

  1. 1Education & Training on GCP and clinical trial related regulations and guidelines
  2. 2SOP development and maintenance
  3. 3Support inspections by MFDS