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Quality Assurance

At DiagnoSearch, Clinical Quality Assurance (CQA) is the foundation of our work. With 30+ years of experience, our QA team ensures that every clinical trial process is compliant, reliable, and globally benchmarked.

Through independent oversight, risk-based audits, and a culture of continual learning, we embed Good Clinical Practice (GCP) principles across every stage of research, from study design to submission. This ensures data integrity, participant safety, and results that sponsors can trust.

Our Quality Assurance Framework

Quality Management System (QMS)

Comprehensive system ensuring processes meet global regulatory standards, local requirements, and sponsor expectations

Right the First Time

Strong SOP-driven approach designed to deliver accuracy and efficiency.

Quality by Design (QbD)

Data quality, participant safety, and compliance built-in from study planning to close-out.

Independent Oversight

Our QA team functions independently, providing unbiased monitoring and reporting.

Risk-Based Audits

Focus on critical areas for participant safety, regulatory compliance, & data integrity.

Continuous Learning

Regular internal workshops, external training, and industry-focused webinars ensure QA expertise evolves with science and regulation.

Clinical Quality Assurance

Integrated QA Services

Our clinical quality assurance services cover the full trial lifecycle

Investigator Site Audits
Ensuring compliance with protocol, SOPs, and regulations, with guidance on Corrective and Preventive Actions (CAPA).
GCP Training Workshops
Tailored Good Clinical Practice (GCP) training to equip investigator sites with practical compliance strategies.
Vendor & Service Provider Audits
Independent evaluations of third-party processes to ensure alignment with regulatory and sponsor standards.
Partner Laboratory Audits
Assessing assay standardization, QC processes, and SOP development to ensure reliability of laboratory data.

The DiagnoSearch Advantage

Our Quality Assurance team brings deep, hands-on, cross-functional experience from clinical research operations, clinical data management, site audits, medical writing, and vendor qualifications.

Global Reach, Local Strength

Investigator site audits and GCP training across India, Africa, Southeast Asia, and Latin America both in-person and remote. Countries include Burkina Faso, Kenya, Malawi, Mali, Mozambique, Niger, Colombia, and Honduras.

Cross-Functional Expertise

Our QA team blends experience from clinical operations, data management, medical writing, vendor qualifications, and auditing to bring a 360° perspective.

Proven Regulatory Track Record

  • 1 DiagnoSearch facility inspection
  • Consistently sustained compliance and supported sponsors during regulatory inspections
  • CAP accreditation since 2005
  • 11 inspections from the College of American Pathologists
  • NABL accreditation (ISO 15189) since 2013
  • 8 inspections by the National Accreditation Board for Testing Laboratories

Trusted by Global Public Health Agencies

Conducted audits for

  • Centers for Disease Control and Prevention (CDC), USA
  • Robert Koch Institute, Germany
  • Health Protection Agency, UK
  • ICGEB, Delhi
  • Christian Medical College (CMC), Vellore
  • NIV, Pune and RGCB Trivandrum

Building Quality into Every Trial

At DiagnoSearch, the role of quality assurance in clinical trials is more than compliance — it’s about building confidence in science. By embedding QMS-driven oversight, risk-based strategies, and global regulatory insights, we ensure every project is conducted with integrity, accountability, and operational excellence.

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