
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.