Services

Quality Assurance


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Going the extra mile in promoting excellence for our Pharma, Biotech, and Academic Sponsors

OPIS quality culture is integrated into the entire clinical trial management process, and the Quality Management Unit is responsible for establishing and ensuring, and continuously improving the quality of processes, data, and documentation associated with clinical research activities managed by the Company.

The responsibilities of the Quality Management Unit include:

  • Management of the Quality System (ISO 9001:2015 certification)
  • Internal audit plan preparation and management
  • Quality assurance for clinical trials
  • Reference for ICH-GCP related issues
  • Training content preparation and delivery
  • Support in audit/inspection preparation at site
  • Ad hoc activities as per Sponsor’s requirements

Regulatory
Trial Start-Up
Study Management and Monitoring
Data Management
SAS Programming
Statistical Analysis and Consultancy
Pharmacovigilance
Quality Assurance
Medical Affairs and Medical Writing
Preclinical and Drug Development Consultancy
Project Control
e-Clinical Patform - OPIS CLINICAL.NET