Our services

                                           

Quality Assurance

Our Quality Assurance Team is independent of the Clinical, Preclinical & Analytical teams. The Quality Assurance team ensures that the conduct of the Clinical and Preclinical study and the generation, documentation and reporting of the data complies with the protocol, Good Clinical Practices (GCP), Good Laboratory Practices (GLP) standards and applicable regulatory requirements.

The quality system is kept updated by periodic internal and vendor audits and review and updatation of the SOPs as and when required in sync with the latest GCP and GLP regulatory guidelines. Proper Change Control and CAPA System and documentation of the same follow changes in the system.

All steps involved in data management are documented in order to allow step-by –step in-process and retrospective assessment of the quality of the data and the performance of the clinical study. The documentation is facilitated by methods such as use of checklists and forms, details of action taken, dates, and individual responsibilities etc. The team assures that all observations and findings are verified for the credibility of the data and that the conclusions presented are correctly derived from the raw data. The verification process is specified and justified.

The Quality Assurance team ensures that other staffs are trained periodically in latest regulatory guidelines to enable the staff follow Good Clinical and Good Laboratory Practices.

 

Audit System of Pharmacy

  1. Storage Temperature/RH log
  2. Entry-Exit log
  3. Drug product accountability form
  4. Site supply accountability form
  5. Drug issuance form
  6. Drug receipt forms
  7. Drug return/ destruction form

Training and Development of Staff

Training and Development :
Internal and external training is a continuous process for all personnel at the CRO.

  1. Start-up Meetings/Trainings
  2. Protocol Specific Training
  3. GCP Training
  4. Recruitment  / Site specific Training