At Ardent Clinical Research Services, our SOPs are the foundation of operational excellence. Developed in alignment with ICH-GCP and national/international regulatory requirements, these procedures guide every facet of our clinical trial lifecycle with rigor, consistency, and ethical responsibility.
Our SOPs are our commitment to quality and integrity.
✅ Ensure regulatory compliance and alignment with global best practices
🔁 Promote process standardization across all trials and sites
🔍 Enable real-time monitoring, audit-readiness, and performance tracking
🧠 Serve as a comprehensive training for new and existing staff
🔐 Safeguard data integrity, subject safety, and study reliability
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Fast, compliant submissions of protocols and amendments to IECs
Role delegation, training, and staff oversight
TMF setup, version control, and secure archiving
Feasibility, outreach, and strategic enrolment preparation
Ethical, clear, and well-documented consent process
Seamless screening, eligibility checks, and enrolment tracking
Visit compliance, AE/SAE reporting, and ongoing monitoring
SOPs for IP receipt, storage, dispensing, and accountability
Real-time review of clinical data and safety parameters
Risk-based monitoring, deviation tracking, and CAPA execution
Efficient data entry, Source Data Verification (SDV), query resolution, and database lock procedures
Ensures compliance with ALCOA+ principles, secure audit trails, and robust data backup systems
Consistent and accurate AE/SAE coding using the latest MedDRA version, enhancing regulatory compliance and data quality
Implementation of in-process QC checks, internal and external QA audits, and proactive deviation tracking
Customized Study-Specific Plans (PMP, REMP, CQMP, IP Management Plan, MP, Safety Management Plan etc) outlining monitoring approaches, audit strategies, risk mitigation measures, and site compliance expectations tailored to the study's design and complexity
Systematic documentation and resolution of protocol deviations, with Corrective and Preventive Actions (CAPA) integration
Ongoing compliance tracking, inspection preparedness, and continuous process improvement
Development of SAPs, including mock shells, output specifications, and statistical methodology aligned with protocol objectives
Generation of analysis datasets derivation logic, validation procedures, and TLF (Tables, Listings, Figures) creation
Collaborative review of results with medical writers and clinical teams for accurate, meaningful data presentation
Protocols, CSRs, safety narratives, and regulatory reports
Interactions with authorities, hold management, and documentation
Final reconciliation of data, IP, and archival of study records
Rigorous selection process based on technical capability, compliance history, service quality, and data security standards
Clear documentation of scope, deliverables, timelines, and compliance obligations
Performance tracking through KPIs, regular audits, and documented communication
Customized plans outlining oversight strategy, communication flow, risk management, and escalation pathways for third-party vendors (e.g., CROs, central labs, EDC providers, logistics partners)
Investigator meetings, site support, and sponsor collaboration
Version control, re-training, and change management
KPI tracking, inspection preparedness, and ongoing process refinement
At Ardent, SOPs are more than compliance tools — they are an embodiment of our values and vision. By standardizing processes, we: