Corporate

Quality Policy

  • Providing timely, accurate, secure and quality clinical data to our clients
  • Always work towards to the utmost satisfaction of our clients.
  • To provide knowledge-based technological services to satisfy the needs of client and the industry
  • To pursue global standards of excellence in all our endeavours namely clinical research, and consultancy and to remain accountable in our core and support functions, through processes of self-evaluation and continuous improvement.
  • Through a concerted effort, we intend to emerge as the leaders in our field.
  • To ensure that quality is not just another goal, but a basic strategy for survival and growth

Quality Assurance & Audits

At Sapthagiri Clintrac, we have a Quality Assurance (QA) team which reports to the top management and independently audits Clinical, Bioanalytical, PK & Statistical activities, to ensure compliance to Protocol, SOPs, GCP, GLP and other applicable regulatory requirements. Our QA team ensures the adaptation and implementation of the best-in-industry practices and processes in line with the regulatory requirements.

Our QA team ensures constant updating of processes, procedures to any changes in the regulatory guidelines

The audit team carries out in-process & retrospective study audits and periodic vendor audits. The team also assesses and responds to regulatory queries post submission to the authorities. It assures conformity to Sponsor and regulatory requirements, while maintaining a high cadre of transparency and communication.

The QA team is responsible for

  • Coordinating all regulatory inspections and applicable Sponsor qualification audits
  • Controlling revisions of Standard Operating Procedures (SOP) and applicable forms
  • Document Management
  • Implementation of Quality Management Systems
  • Report /Dossier submission in E3 and eCTD formats
  • Conducting internal audits
  • Study Audits for protocol, GCP, GLP and SOP compliance
  • Consistently meeting the Sponsor’s expectations for quality of project
  • Site Audits
  • Periodic Training of staff
  • Systems / Process Audits
  • Vendor Audits
  • Document Audits (Protocol, Clinical Study Reports & essential Clinical Trial documents) and Data base audits
  • Archival Management