Ardent

Our Approach to Clinical Monitoring

The clinical sites involved in your study may be spread across multiple geographies, and ensuring consistency and compliance can be challenging. That’s where our highly skilled Clinical Research Associates (CRAs) come in.

Offer fast, efficient, and proactive site support
Bring strong therapeutic knowledge and in-depth clinical expertise
Are trained in FDA regulations, ICH-GCP, and internal SOPs
Operate with a patient-first mindset while ensuring protocol fidelity and data quality

Core Responsibilities of Our Clinical Monitoring Team

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Site Selection & Investigator Qualification

Assist in identifying and evaluating qualified investigators and trial sites
Confirm investigators are appropriately credentialed
Verify required infrastructure and protocol-driven research capabilities

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Site Initiation and Training

Conduct site initiation visits (SIVs) and comprehensive training
Study protocol, objectives, and ICH-GCP guidelines
Informed consent procedures and adverse event reporting
Study-specific systems and documentation protocols

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Routine Monitoring Visits

Perform interim monitoring visits (IMVs) for compliance
Ensure ethical subject recruitment per protocol
Verify eligibility, randomization, and dosing accuracy
Monitor data entry and query resolution processes

✅

Source Data Verification (SDV)

Compare CRF/EDC data with original source records
Confirm accuracy, completeness, and data integrity
Validate clinical data against source documentation

📝

Informed Consent Review

Verify consent obtained prior to trial procedures
Ensure compliance with IRB/IEC and regulatory standards
Confirm use of approved, updated ICF versions

📦

Investigational Product Accountability

Track storage conditions, handling, and dispensing of IP

Maintain drug accountability logs and reconciliation

Document and account for all unused supplies

🚑

Safety Monitoring

Review and document adverse events (AEs) and SAEs

Ensure timely reporting per protocol requirements

Follow up on safety events within regulatory timelines

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Documentation & Reporting

•Prepare detailed monitoring visit reports

•Maintain and update Trial Master File (TMF)

•Support audit readiness and documentation integrity

Monitoring Visit Types We Conduct:

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Pre-study visits (PSVs)

Initial site assessment and preparation

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Site Initiation Visits (SIVs)

Comprehensive training and study launch

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Interim Monitoring Visits (IMVs)

Regular oversight and compliance checks

✓

Close-out Visits (COVs)

Final documentation and study completion

⚠️

For-cause visits

Triggered by risk or performance concerns

Why Choose ACRS for Clinical Monitoring?

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Therapeutic Area Expertise

Oncology and cancer research specialization
Gastroenterology and digestive disorders
Neurology and neurological conditions
Infectious diseases and immunology

🏆

Experienced CRA Team

GCP-certified Clinical Research Associates

Located across major research regions in India

Extensive therapeutic area knowledge

Proven track record in clinical monitoring

📊

Risk-Based Monitoring

Optimized site oversight capabilities

Real-time data review and analysis

Proactive issue escalation protocols

Continuous recruitment tracking

❤️

Quality & Safety Focus

Unwavering focus on patient safety

Strict protocol compliance standards

High-quality data integrity assurance

Ethical research conduct principles

At ACRS, our goal is simple: to ensure that your clinical trial is monitored efficiently, that patient safety is protected, and that high-quality, reliable data is delivered — all within your study’s timelines and budgets.

Partner with us for dependable, insightful, and compliant clinical monitoring services.