Medical Monitoring

Ensuring safety and integrity in clinical trials

Medical Monitoring is at the heart of patient protection and data reliability in clinical research. As trials become increasingly complex, independent medical oversight provides the bridge between clinical judgment, operational execution, and regulatory accountability.

At CLT Vigilance Consulting, Medical Monitoring acts as the sponsor’s medical conscience — ensuring that every participant’s well-being and every data point’s validity are safeguarded.

Core activities include:

Providing thorough safety oversight as part of sponsor regulatory oversight requirements, supporting informed go/no-go decisions in drug development.
Reviewing and assessing Adverse Events (AEs) and Serious Adverse Events (SAEs) for severity, causality, and expectedness.
Evaluating protocol deviations with potential clinical or safety impact.
Providing guidance on patient eligibility and medical aspects of protocol adherence.

Supporting study teams and investigators in day-to-day medical questions.
Participating in Safety Review Meetings.
Contributing to protocol design and amendments where medical input is critical.
Writing and reviewing Medical Monitoring Plans (MMPs) and Safety Management Plans (SMPs).

Value to client

CLT Vigilance Consulting provides proactive, independent, and auditable medical oversight, grounded in the expertise of Cornelia Lif-Tiberg, MD. Combining clinical experience with industry insight, this approach ensures that risks are identified early, decisions are documented transparently, and sponsors can demonstrate compliance with regulatory frameworks such as ICH-GCP, ICH E6 (R3), MDR, ISO 14155, and IVDR — protecting both patients and programs.