Accurate, timely medical oversight is essential for participant safety and data quality. hVIVO's Medical Monitoring and Safety Services provide direct access to GCP-certified physicians with extensive Phase I, II & III trial experience.
This service is available as a standalone solution, offering a consistent, expert-led approach to safety monitoring from first patient to data lock.
Continuous medical input from trial setup to final data review
Expert review of clinical data including laboratory results, vital signs, and ECGs
Continuous AE/SAE monitoring to identify and address safety signals promptly
Eligibility and protocol compliance checks to maintain trial integrity and patient safety
Input into key study documents across the trial life-cycle, for example safety reports such as protocol, Safety Management Plan, DSURs, Investigator Brochures, DMC documentation, TFL review and Clinical Study Report writing and review.
Optional pharmacovigilance support including expedited reporting and event narratives
Our medical monitors act as dedicated safety leads, ensuring real-time, medically sound decisions across your clinical program. They collaborate closely with investigators, sponsors, and operational teams to assess ongoing safety, manage risk, and ensure patient well-being throughout the trial lifecycle.
Remote monitoring by in-house hVIVO physicians
Dedicated or ratating medical monitors for uninterrupted coverage
Flexible support to reflect study needs - Lite, Full or PV+
Specialist oversight from clinicians with hands-on trial expertise
Enhanced participant safety and reliable clinical data
Flexible engagement models for biotech, academic and global sponsors
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