Clinical Site Operations

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Clinical Site Operations

End-to-End Support for High-Quality, Efficient Clinical Trials

At Mentriix Clinical Research, we provide comprehensive Clinical Site Operations services designed to optimize trial execution, improve patient recruitment, and ensure compliance across all study phases. Our team brings deep therapeutic expertise, operational excellence, and global site-management capabilities to support sponsors, CROs, and research networks.

Our Core Clinical Site Operations Services

 1. Site Identification & Feasibility

Identification of high-performing clinical research sites

Feasibility assessments based on patient availability, infrastructure, and experience

Coordination with site teams to evaluate operational readiness

Feasibility tracking & reporting for sponsors

 2. Site Selection & Activation

Complete site qualification & onboarding

Regulatory document collection & support

EC/IRB submission preparation

Start-up package management

Training for site staff on study protocols and systems

3. Clinical Monitoring & Oversight

Remote and onsite monitoring (PSV, SIV, RMV, COV)

Source data verification & query resolution

Safety reporting oversight

Monitoring visit reports & follow-up

Risk-based monitoring support (RBM/RBQM)

 4. Study Coordination & Site Management

Dedicated Clinical Research Coordinators (CRCs)

Protocol training & continuous support

Visit scheduling and patient workflow management

Site compliance tracking and operational troubleshooting

Maintaining study documentation (ISF, logs, forms)

 5. Patient Recruitment & Retention Support

Recruitment planning and forecasting

Engagement strategies for diverse patient populations

Retention solutions to reduce drop-out rates

Site-specific recruitment performance dashboards

6. Regulatory & Quality Compliance

SOP-driven site operations

GCP compliance oversight

Audit preparation & audit response support

Ensuring adherence to sponsor, CRO, and regulatory requirements

Quality Issue tracking and CAPA management

7.Vendor Coordination & Study Support

Liaison with central labs, imaging vendors, logistics partners

Site supplies management

Training coordination for vendor systems & tools

Support for electronic data capture (EDC) and safety systems

8.Close-Out & Study Completion

Close-out visit activities

Archiving support & document handover

Reconciliation of investigational products & supplies

Final quality checks before study lock

 

 Why Choose Mentriix for Site Operations?

✔ Strong presence across India, USA, and South Africa

✔ Experienced CRAs, CTAs, CRCs, and Clinical Project Managers

✔ Faster activation timelines

✔ Decentralized & hybrid monitoring capabilities

✔ High-quality site performance with low query turnaround times

✔ Proven track record across Oncology, Neurology, Endocrinology, Orthopedics, Rare Diseases, and Infectious Diseases

 

Flexible Engagement Models

We support:

Full-Service Clinical Operations

FSP (Functional Service Provider) models

Site Management Support

Dedicated monitoring teams

Per-site, per-visit, or full-study oversight

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