top of page

SERVICES

Clinical Quality Assurance

At In2Clinical, we provide independent Clinical Quality Assurance services designed to safeguard patient safety, data integrity, and regulatory compliance in clinical research.

​

With over 25 years of experience in clinical development, we support sponsors, CROs, and investigators by delivering tailor-made quality solutions that meet international GCP standards.

​

Our key services include:

​

GCP Auditing

  • Trial Master File (TMF) audits – ensuring completeness, accuracy, and regulatory compliance.

  • Investigator Site audits – assessing GCP compliance and site readiness.

  • Vendor qualification audits – evaluating CROs, laboratories, technology providers, and other partners.

  • Process and system audits – reviewing SOPs, workflows, and internal controls.

 

Compliance Support

  • Inspection readiness assessments.

  • Gap analysis and risk-based quality reviews.

  • Oversight of outsourced clinical activities.

  • Development of pragmatic quality improvement plans.

 

Advisory & Training

  • Strategic quality consulting for clinical development programs.

  • Tailored GCP training sessions for teams and investigators.

  • Support in strengthening internal Quality Management Systems (QMS).

Every organization has unique challenges and requirements. At In2Clinical, we adapt our services to your needs, offering flexible, independent, and solutions-driven quality oversight.

​

By combining deep expertise with a hands-on approach, we aim to:

​

  • Minimize regulatory and operational risks.

  • Ensure inspection readiness at all times.

  • Provide clear, actionable findings and recommendations.

  • Build long-term quality partnerships with our clients.

 

Our mission is simple: Quality you can trust.

Our Approach

bottom of page