Quality Management at Ardent

Excellence in Clinical Research Through Rigorous Quality Standards. At ACRS, quality is not just a standardโ€”it is the foundation of everything we do. We understand that in clinical research, precision, compliance, and integrity are paramount. That's why our operations are anchored in a robust, end-to-end Quality Management System (QMS) that ensures every project is executed with consistency, accuracy, and regulatory excellence.

Our QMS is built to align seamlessly with international guidelines, including ICH-GCP E6 (R3), which defines quality assurance as "all planned and systematic actions established to ensure that testing is performed and data is generated, documented, and reported in accordance with Good Clinical Practice (GCP) and applicable regulatory requirements."

At the heart of our QMS is a multidisciplinary team of Quality Assurance (QA) and Quality Control (QC) professionals. These experts bring together diverse skill sets and extensive experience to implement strategic quality initiatives, risk-based monitoring, and continuous process improvements. From protocol development to final reporting, every step is monitored, reviewed, and continuously improved.

Our Quality Framework Includes:

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Internal Project-Specific Audits & Compliance Reviews

Focused audits to ensure that individual projects adhere to protocol, GCP, regulatory and sponsor requirements.

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System Audits

Routine evaluations of computerized systems to ensure validation, security, and compliance.

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Department-Specific Audits

Audits tailored to assess performance and compliance within individual departments like Clinical, QA, or Data Management, Biostatistics etc.

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On-Site & Remote Audits

Flexible audit execution modes to maintain oversight regardless of location or trial phase.

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Vendor Qualification & Requalification

Rigorous evaluation of third-party vendors to ensure service quality and regulatory compliance.

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External Audit & Inspection Management

Comprehensive support during sponsor and regulatory inspections, ensuring readiness and timely response.

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Robust SOPs & Documentation Practices

Well-defined and regularly updated SOPs that guide consistent, compliant trial execution.

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CRO SOP & Clinical Quality Management Plan (CQMP) Implementation

Customized quality frameworks developed and applied to ensure trial-specific operational excellence.

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Risk Identification & CAPA Management

Proactive approach to detect, analyse, and resolve quality issues with structured corrective actions.

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Quality Matrix and Key Performance Indicator

At ACRS, we track key quality metrics to ensure regulatory compliance, continuous improvement, and consistent delivery of high-quality clinical trial results.

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Ongoing Training & Competency Development

Continuous learning programs to maintain staff proficiency and regulatory awareness.

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Real-Time Data Review & Integrity Checks

Continuous data monitoring to ensure accuracy, completeness, and compliance with ALCOA++ principles.

Our quality-first culture empowers our team to deliver exceptional outcomes in globally recognized, award-winning clinical trials. With ACRS, sponsors can be confident that their studies are being conducted to the highest standards of scientific and ethical integrity.

Why Our QMS Stands Out

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Award-Winning Quality Performance

Recognized for excellence in multiple international clinical trials, reflecting our deep commitment to quality, compliance, and innovation.

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Seamless Integration of Clinical, Regulatory, and Data Functions

Cross-functional collaboration ensures efficient trial execution, faster turnaround, and complete alignment across departments.

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Transparent Communication and Real-Time Reporting for Sponsors

Sponsors have full visibility through timely updates, dashboards, and proactive issue resolutionโ€”no surprises, just trust and clarity.

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Dedicated QA Oversight from Study Initiation to CSR Approval

Our Quality Assurance team is involved at every stage, ensuring GCP compliance, early risk detection, and consistent quality from start to finish.

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Inspection Readiness Culture

We maintain a constant state of readiness for regulatory audits and inspections, supported by structured documentation, training, and mock audits.

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Strong Focus on Patient Safety and Data Integrity

Every decision, process, and deliverable are aligned with our core values: protect patient rights, ensure safety, and uphold data credibility.

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Proven Track Record Across Multiple Therapeutic Areas

From oncology to rare diseases, our team has delivered quality-driven results across diverse and complex therapeutic domains.

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Tech-Enabled Quality Monitoring

Utilization of validated electronic systems and analytics tools allows real-time quality checks, deviation tracking, and faster CAPA implementation.

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Sponsor-Centric Philosophy

We customize quality strategies to align with each sponsor's protocol, goals, and risk profileโ€”ensuring personalized, reliable outcomes.