Quality Operations
Quality Is Foundational to Every Study We Conduct
Our Quality Operations team works to ensure the integrity, safety, and compliance of every trial. We support both our internal teams and our clients in meeting the highest regulatory and ethical standards.
Commitment to Quality
Our Quality Operations team provides study recommendations and process improvements that support the safest and most efficient means of conducting trials, while ensuring full compliance with all protocol, sponsor, and regulatory requirements. We emphasize proactive quality oversight to minimize risks and protect both study participants and data integrity.
Quality is more than compliance. It’s how we ensure safety, reliability, and confidence in every study we conduct.
Comprehensive Quality Management
Lotus maintains a robust Quality Management System (QMS) designed to ensure that procedures, documentation, and deliverables meet regulatory expectations, including ICH-E6(R3), and EMA guidelines for data privacy. We help ensure that every study operates with consistency, accuracy, and adherence to the highest standards of clinical research.
Development of study-specific, quality-focused operational plans and risk assessments
Direct point of escalation for both internal teams and our clients to ensure swift and efficient actions/resolution
Why Choose Lotus for Quality Operations
- Experienced Quality Operations professionals
- Proven GCP auditing expertise across multicenter trials
- Comprehensive QMS aligned with regulatory standards
- Proactive risk-based quality oversight
- Commitment to continuous improvement and transparency
GCP Auditing & Compliance
For multicenter studies, Lotus can leverage highly experienced GCP auditing professionals to conduct site audits that confirm compliance with study protocols, Good Clinical Practice, and all applicable federal regulations. Quality Operations ensures complete transparency with our sites and sponsors to provide actionable insights, as well as corrective and preventive action guidance.
Regulatory Alignment & Inspection Readiness
Our Quality Operations staff collaborate with sponsors, CRO partners, and investigative sites to ensure that every project is fully aligned with regulatory expectations. We also support sponsor audits and implement BIMO inspection activities which are fully transparent with our sponsors to support inspection readiness.
Continuous Improvement
Quality at Lotus is an ongoing process. We continuously evaluate study performance, feedback, and audit outcomes to identify opportunities for improvement. This data-driven approach ensures that we not only meet compliance requirements—but also drive operational excellence across all programs.