QERM is at the heart of our commitment to delivering safe, effective, and high-quality clinical solutions. Our goal is simple: to ensure the “absence of errors that matter” while accelerating the development of innovative medical therapies.

By applying a risk-based approach and the principles of Quality Risk Management (QRM), we proactively detect and mitigate potential issues, ensuring compliance with regulatory guidelines and maintaining the highest standards of subject safety and data integrity. With an independent and collaborative approach, QERM works seamlessly with sponsors and operational teams to drive continuous process improvement and regulatory excellence.

Core Quality Excellence Services

Our QERM team offers a comprehensive suite of services to provide independent oversight and ensure compliance throughout the clinical research lifecycle.

Site and Vendor Oversight

• Investigator Site Audits: Comprehensive assessments to ensure site compliance with protocols, regulatory requirements, and good clinical practice (GCP).
• Vendor Audits: Evaluation of third-party vendors to verify quality and compliance with study requirements.

Operational Quality Assurance

• System and Process Audits: Ongoing assessments of operational systems and processes to ensure alignment with SOPs and regulatory expectations.
• Quality Event Management and Corrective/Preventative Actions (CAPA): Proactive management of quality events, root cause analysis, and implementation of corrective and preventative measures.
• GLP Audits: Oversight of preclinical activities to ensure adherence to Good Laboratory Practice (GLP).

Regulatory Support Services

• Inspection Preparation and Management: Guidance and support for regulatory inspections, including mock inspections and gap analysis.
• GxP Training: Comprehensive training programs on GLP, GMP, and GCP to enhance team compliance and readiness.
• Document Control Oversight: Management of regulatory documentation to ensure traceability, consistency, and compliance.

Sponsor-Centric Quality Assurance Services

For sponsors seeking independent quality oversight, QERM provides tailored services to align with your study goals and regulatory requirements.

Sponsor Audit Support

• Investigative Site Audits: Ensuring investigator sites meet the highest standards of compliance and data quality.
• Vendor Audits: Assessment of vendors and subcontractors to verify adherence to contractual and regulatory obligations.
• Internal Audits: Comprehensive evaluations of sponsor-led processes and systems for quality improvement.

Regulatory Readiness

• Mock Regulatory Inspections: Simulated inspections to identify gaps and prepare for real-world regulatory assessments.
• Regulatory Training Programs: Focused training sessions to align sponsor teams with GLP, GMP, and GCP requirements.

The iGlobal Advantage in Quality Excellence

1. Proactive Risk Management: Early detection and mitigation of potential risks to avoid delays, non-compliance, or operational inefficiencies.
2. Regulatory Expertise: Deep understanding of global regulatory requirements ensures smooth preparation for inspections and submissions.
3. Independent Oversight: An impartial, third-party approach to quality assurance provides sponsors with unbiased, actionable insights.
4. Continuous Improvement: By fostering a culture of quality, we ensure every process is continuously optimized for excellence.

Partner with iGlobal QERM for Quality You Can Trust

At iGlobal, our Quality Excellence & Risk Management services go beyond compliance—we create a foundation for clinical trial success. With a focused, directed approach, we enable sponsors to meet regulatory expectations while maintaining subject safety and data integrity.

Choose iGlobal for precision-driven quality assurance solutions that set your clinical trial up for success.