Quality Assurance

We ensure the highest clinical quality with clinical trial data management.

Our Quality Assurance 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 compliance 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.

Reviewing a document beside a gavel and scales
Services

Project Audits

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

Additional Services

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