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Harvest IRO Medical Monitoring
Harvest IRO Medical Monitoring
* Experienced * Integrated * Responsive * Trusted
* Experienced * Integrated * Responsive * Trusted
* Experienced * Integrated * Responsive * Trusted
* Experienced * Integrated * Responsive * Trusted
* Experienced * Integrated * Responsive * Trusted
* Experienced * Integrated * Responsive * Trusted
* Experienced * Integrated * Responsive * Trusted
* Experienced * Integrated * Responsive * Trusted
IRO For Medical Monitoring

01

Safety Oversight & Patient Protection

Physician-led review of AEs, SAEs, SUSARs, and safety signals—ensuring patient well-being and regulatory compliance at all times.

02

Eligibility & Enrollment Guidance

Expert review of inclusion and exclusion criteria, complex cases, and special populations to reduce screen failures and support enrollment.

03

Clinical Data Review & Interpretation

Ongoing medical review of eCRFs, protocol deviations, and interim data to strengthen decision-making and provide clear efficacy insights.

04

Operational & Compliance Support

Medical Monitoring Plans, investigator meetings, and GCP-aligned documentation that support audits and regulatory interactions.

05

Global Medical Expertise

Physician teams experienced across the U.S., Europe, and Asia-Pacific, aligned with FDA, EMA, PMDA, NMPA, TFDA, and TGA expectations.