Your partner in global clinical trial operations.
Site Collaboration | Patient-Centered Study Operations
Our Focus
LunaClinical supports clinical trial operations through site collaboration, regulatory coordination, and sponsor oversight. Led by our Senior Clinical Research Associate (PharmD), Harvard-trained clinical researcher, and recipient of the 2024 PharmaTimes – Clinical Researcher of the Year (Global Project Team) Gold Award, our team includes experienced advisors based in the U.S. supporting sites across multiple therapeutic areas worldwide.
Therapeutic areas: immunology, neurology, CNS, oncology-device, ophthalmology, and infectious diseases.
LunaClinical Services:
1. Study Start-Up Coordination
Guidance on study feasibility, site selection, regulatory submissions, and site readiness to ensure a smooth trial launch.
2. Clinical Research Consultant (On-site / Remote)
Flexible clinical trial support (on-site or remote) across diverse therapeutic areas with sponsor-aligned oversight.
3. Clinical Site Oversight & Visit Documentation
Full-cycle site visits (pre-study through close-out) with timely documentation that meets regulatory and study requirements.
4. Protocol Compliance Oversight
Ongoing oversight of site conduct and protocol adherence, ensuring studies remain compliant and data stays reliable.
5. Data Review, Verification & Query Management
SDR, SDV, and EDC query resolution to ensure accurate, compliant, and high-integrity data across sites.
6. Centralized & Risk-Based Monitoring
Centralized and risk-based monitoring, with support for data trends, remote oversight, and proactive site engagement.
7. TMF Readiness & Audit Support
8. Regulatory Document Support
Regulatory document support with binder setup, ICF coordination, and submission management to keep documentation compliant and audit-ready.
9. Patient Recruitment & Retention Support
Collaborate with sites to drive enrollment and reduce participant dropout through tailored retention strategies.
10. Cross-Functional Collaboration
Facilitating collaboration between sponsors, vendors, and clinical sites to ensure timely execution and operational efficiency.
Stay connected: Follow LunaClinical on LinkedIn for updates on site collaboration, trial operations, and patient-focused research support.