Embedded Files
📞 Connect with iViTAA CONSULTANCY
Protecting patient safety. Enhancing data integrity. Ensuring trial compliance.
Protecting patient safety. Enhancing data integrity. Ensuring trial compliance.
At IVITAA CONSULTANCY, our GCP services focus on delivering robust audits and system evaluations across the clinical research landscape—excluding direct investigator sites. We provide clients with clear visibility into their clinical operations, technology platforms, and vendor systems to ensure adherence to global regulatory and ethical standards.
At IVITAA CONSULTANCY, our GCP services focus on delivering robust audits and system evaluations across the clinical research landscape—excluding direct investigator sites. We provide clients with clear visibility into their clinical operations, technology platforms, and vendor systems to ensure adherence to global regulatory and ethical standards.
Our GCP Audit Scope Includes:
Our GCP Audit Scope Includes:
System & Operations Audits
In-depth reviews of Contract Research Organizations (CROs), IVRS platforms, clinical trial supply chains, central/hospital laboratories, and computerized systems managing drug safety, trial data, and statistical outputs.
System & Operations Audits
In-depth reviews of Contract Research Organizations (CROs), IVRS platforms, clinical trial supply chains, central/hospital laboratories, and computerized systems managing drug safety, trial data, and statistical outputs.
End-to-End Clinical System Review
Coverage extends from In-House Phase 1 Units to data management teams and statistical departments—up to the preparation of Clinical Study Reports (CSR) and Clinical Pharmacokinetics (PK) documentation.
End-to-End Clinical System Review
Coverage extends from In-House Phase 1 Units to data management teams and statistical departments—up to the preparation of Clinical Study Reports (CSR) and Clinical Pharmacokinetics (PK) documentation.
Process Mapping & Optimization
Visualizing workflows to identify bottlenecks, inefficiencies, and regulatory risk points, with improvement strategies embedded into current systems.
Process Mapping & Optimization
Visualizing workflows to identify bottlenecks, inefficiencies, and regulatory risk points, with improvement strategies embedded into current systems.
Validation of Computerized Systems
Oversight or leadership of system validation efforts, ensuring data reliability and compliance with GCP-aligned expectations for clinical trial technology platforms.
Validation of Computerized Systems
Oversight or leadership of system validation efforts, ensuring data reliability and compliance with GCP-aligned expectations for clinical trial technology platforms.
With IVITAA, you gain independent assurance that your clinical operations are audit-ready, inspection-compliant, and aligned with ethical and regulatory mandates.
With IVITAA, you gain independent assurance that your clinical operations are audit-ready, inspection-compliant, and aligned with ethical and regulatory mandates.
Have a Compliance Challenge?
Let’s Solve It — Together.
All consultations are strictly confidential and handled by senior regulatory experts
Page updated
Google Sites
Report abuse