Preeta Caroline

Quality Assurance Lead

Role

Degree

Masters in Pharmacy (Pharmacology)

Personal Info

cp@clinigma.com

About

Preeta brings over a decade of experience in pharmaceutical and medical research administration, with deep expertise in quality assurance, compliance, and regulatory operations. As CLINIGMA®’s Quality Assurance Lead, she ensures that all in-trial interview studies meet the highest standards of data integrity, protocol adherence, and ethical compliance.

Expertise

Regulatory and Quality Oversight
  • 10+ years of experience supporting cross-functional pharmaceutical teams, including medical affairs, regulatory, and quality assurance
  • In-depth knowledge of ICH-GCP and ISO quality standards with practical experience implementing and auditing compliance protocols
  • Proven ability to navigate ethical review board processes, consent procedures, and documentation review in both clinical and observational studies
Clinical Research Operations
  • Previously supported a wide range of clinical research projects at Columbia Asia Hospitals and multinational pharma companies
  • Direct experience in coordinating with investigators, monitoring teams, CROs, and internal departments to uphold regulatory compliance
  • Strong understanding of SOP management, data verification, and safety reporting in research environments
Document and Data Integrity
  • Skilled in maintaining essential study documentation including CRFs, ICFs, site master files, and deviation logs
  • Familiar with quality control procedures across qualitative and quantitative methodologies, including transcription and translation workflows
Academic and Sector Background
  • Master’s degree in Biotechnology from Bharathidasan University
  • GCP certified and well-versed in global research standards and evolving regulatory landscapes

Preeta’s leadership in quality assurance helps safeguard the scientific rigour and ethical integrity of CLINIGMA®’s work. Her dedication to upholding best practices across all phases of clinical and qualitative research makes her a critical asset in delivering trustworthy and compliant in-trial interview studies.

Publications