What we do

Quality Assurance

We strive for excellence in everything we deliver

Our QA team aspires to excellence and ensures that our teams perform to the highest standards. This experience is leveraged in our quality assurance service offerings. We help customers to develop or update their quality systems and procedures and to conduct 3rd party audits.

Pivotal’s QA team is assembled by professionals with extensive clinical research experience and knowledge of the GCP guidelines and regulations. Our team is versed in IT Quality compliance and how to use a robust Agile methodology for software development and validation.

Our service offerings:

  • System audits (SOPs, processes and staff training)
  • Clinical site audits
  • Trial master file audits
  • Protocol and ICF audits
  • Clinical study documents audits
  • Clinical database audits
  • Laboratory audits
  • Vendors audits
  • Support clients in the preparation for Regulatory Bodies Inspections
  • GCP training services