Medical Monitoring

What we deliver

In early phase trials, the medical questions that carry the most weight rarely wait for business hours. Often, an investigator needs an eligibility call, an urgent safety concern surfaces or an unblinding decision cannot wait. We assign a dedicated medical monitor to each study so those decisions reach a physician who already knows your protocol. On every engagement, sponsors receive:

Medical and safety oversight of the protocol from the synopsis through the CSR
24/7/365 access to the medical monitor for investigator inquiries, protocol deviations, unblinding decisions and urgent medical concerns
Medical review of critical lab values, safety signals and volunteer well-being with periodic summary presentations throughout the study
Serious adverse event management including review of narratives, safety data and supplemental records required for timely reporting
A medical monitoring plan tailored to your protocol and stakeholder preferences
Coverage for studies conducted in the DVCR inpatient unit and for external multicenter programs
The choice of full medical monitoring or a supporting medical monitor to complement your own

Experience snapshot

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Trials conducted as principal investigator or medical monitor

24/7/365

Medical monitor access

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Years combined Phase I expertise

Our medical monitoring approach

Study planning

Medical monitoring begins before the first volunteer is enrolled. During study planning, our medical monitor consults on volunteer selection, endpoint determination, feasibility assessment and site selection, so medical and operational risks are considered while the protocol can still be shaped around them. That review extends to the protocol, the investigator brochure (IB) and the informed consent form (ICF), confirming the adequacy of safety procedures and the presence of appropriate risk language. For first-in-human (FIH) studies, it also covers the preclinical data and the potential class effect of similar compounds, so early safety signals are anticipated before dosing begins.

Medical monitoring plan

The medical monitoring plan is built from a comprehensive template, which allows for rapid creation and customization to the specifics of your study. The plan defines whether eligibility is reviewed before randomization and how often medical monitoring summaries are generated, whether monthly or after each cohort, so the scope of oversight is established with you at the beginning.

Sponsor engagement

The scope is yours to set. Sponsors can engage the full spectrum of medical monitoring services or a supporting medical monitor to complement their own, and the medical monitoring plan can be edited to conform with your standard operating procedures (SOPs).

If indicated, we develop protocol-specific education plans and materials for investigators, study monitors and site personnel, so the team running your study interprets it consistently from the start.

Study conduct

Through study conduct, the medical monitor serves as the primary medical contact for principal investigators and site teams, providing direct support on protocol interpretation and participant management. Volunteer eligibility is confirmed, either prior to or after enrollment based on your needs, and the medical monitor provides recommendations for suitable participants based on prohibited medications and underlying health conditions. Adverse events receive a thorough medical review, and severity assessments of protocol deviations are evaluated.

Safety review

Ongoing safety review draws on data exported from the electronic data capture (EDC) platform as well as laboratory data. The medical monitor reconciles adverse events against protocol-specified safety parameters (e.g. vital signs, ECGs, laboratory results, etc.), identifies intra-subject and inter-subject changes from baseline, and compiles the findings into medical monitoring summaries supported by tables and graphs so conclusions are backed by the underlying data. Where a dose escalation committee (DEC) charter provides for it, the medical monitor reviews all safety data and serves as a voting or non-voting member, so escalation decisions are informed by an independent medical review.

Medical monitor

Throughout the program, our medical monitor works with the project team to identify risks that could affect the safety and reliability of trial results and participates in investigator meetings, safety review committees and regularly scheduled project management meetings.

Our medical monitoring leadership

Medical monitoring is led by experienced physicians who provides medical management for the study and guides the project team and clinical sites on medical and safety protocol-related issues.

George J. Atiee, MD

Director, Medical Monitoring Services

29 years of experience

Cynthia Zamora, MD

Medical Monitor

16 years of experience

Doctor typing on a laptop with a glowing shield icon

Technology, tools and systems

Our medical monitoring approach emphasizes access to safety data and its ongoing analysis through remotely accessible devices, so emerging safety signals can be reviewed as data accrues and changes from baseline can be identified as they emerge. For studies conducted in the DVCR unit, the medical monitor uses ClinSpark® for real-time safety monitoring and for multicenter programs, Medrio® is used.

Quality, standards and compliance

Quality in medical monitoring rests on catching risks early.

Safety and reliability

Medical oversight focuses on protecting participant safety while supporting reliable study outcomes. Our medical monitors provide independent medical review of eligibility decisions, dose escalation recommendations, safety trends and protocol-related concerns, helping sponsors identify and address potential risks before they impact study conduct or data quality.

Adverse events

Reportable events are assessed, documented and followed through resolution to support accurate safety reporting and regulatory readiness. Medical monitors work closely with investigators and sponsors to ensure complete information and timely communication when safety issues arise.

Reporting forms

For each reportable event, whether it be a serious adverse event (SAE), adverse event of special interest (AESI), or pregnancy the medical monitor confirms reporting forms are complete, resolves questions or omissions with the principal investigator, ensures follow-up information is obtained and reviewed through resolution, and facilitates regulatory submissions by confirming the sponsor is fully informed.

Trial master file

Discussions with investigators and sponsor communications, including notes-to-file, protocol clarification letters and amendments are documented in the trial master file (TMF), so the safety record stays traceable across the study.

Connected across the full study lifecycle

Medical monitoring works alongside the functions that generate and manage the data it reviews. Our medical monitor reviews the clinical database produced by data management, while clinical monitoring provides source data verification. Your Project Manager coordinates these processes and handoffs, and the medical monitor joins regularly scheduled project management meetings to keep medical oversight aligned with study conduct.

Related resources

Videos

Medical Monitoring Oversight and Real-Time Data in Clinical Trials

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