Our Advantages
Quality Assurance System

Goal: To close the loop for 90% quality problems in the Business Department based on goal of “progress expedition and QA” in QMS

  • Closing the loop from "region"

    Closing the loop from "region"

    As the first responsible person for the quality at the site, CRA performs monitoring and takes CAPA in accordance with SOP requirement, receives the random shelf life inspection from the Quality Department, and review and verify the rectification results and CAPA implementation

  • Ensuring a smooth process across "line"

    Ensuring a smooth process across "line"

    As the first responsible person for project quality, PM assists CRA in preparing CAPAs for project-level problems found by QA/QC, improves the project management system, and makes investigation for serious problems.

  • Making continuous optimization by “plane”supervision

    Making continuous optimization by “plane”supervision

    QA sets quality goals based on SOP, builds QMS based on CQMS framework, maintains and supervises the accountability system.


200+ effective SOPs under continuous improvement



Internal project QC

Quality audit

Quality audit CAPA  shelf life inspection

Assistant QM

CTMS; medical monitoring

QA&QC Whole Chain Quality Control
Sophisticated QC System

The quality assurance department is independent of all aspects of clinical trials and consists of personnel with many years of clinical trial experience. The team has rich audit experience and a comprehensive training system. The project experience covers phase I-IV, and the indications involve oncology, ophthalmology, endocrinology, gynecology and neurology, etc. Provide a full range of professional assurance for the whole project quality control of customers.

In accordance with domestic and international clinical trial regulations and requirements, Bna quality assurance department has established a comprehensive clinical research standard operating procedures (SOP), and is constantly improving. Through elearning self-learning system, professional skills training and skills sharing are carried out regularly. Through CTMS system and TMF system independently managed, the project management ability will be strengthened to efficiently perform inspection, rectify deviation and timely control risks for the bid party. In accordance with the relevant regulations and the Requirements of the Berneria SOP/ sponsor SOP, the Quality management team of Berneria conducts timely and efficient audit of the clinical trial project, ensures the cooperative operation of the clinical trial, reports the problems found in the audit, and requests the subject to respond to corrective and preventive actions and submit to QA audit.