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. The Medical Monitor 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 to support go/no-go decisions for developing safer drugs.
  • 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/reviewing medical monitoring plans (MMPs) and safety management plans (SMPs)

Value to client

Cornelia brings over a decade of combined clinical and industry experience to deliver proactive, independent, and auditable medical oversight. Her approach ensures that risks are detected early, decisions are documented transparently, and sponsors can demonstrate compliance with regulations för drug development such as ICH-GCP, ICH E6 (R3) guidelines, and within medical device such as MDR, ISO141555 and IVDR — protecting both patients and programs.

Medical Advisory

Strategic medical guidance throughout product development

Sponsors and CROs often need senior medical input without the overhead of a full-time Medical Director. Independent advisory support helps bridge the gap between scientific ambition and operational feasibility — ensuring that study design, safety strategy, and communication with regulators or investigators rest on solid medical reasoning.

Core activities include:

  • Providing medical input to study design, endpoints, and protocol development.
  • Advising on eligibility criteria and risk-mitigation strategies.
  • Supporting Investigator meetings, medical training, and communication with KOLs.
  • Acting as a medical sounding board for operational teams and sponsor leadership.
  • Reviewing clinical documentation such as Investigator´s broschyr (IB), Clinical trial protocol (CTP), Clinical Study Report (CSR), and case narratives for medical accuracy.

Value to client

Cornelia’s background in both clinical medicine and the life science industry makes her an effective medical partner for study teams seeking clarity, confidence, and credibility. She combines a pragmatic understanding of operational constraints with an unwavering commitment to scientific and ethical standards. Her experience spans a broad range of organizations, and she is especially attuned to the specific needs of start-ups and scale-ups.

Pharmacovigilance

Safeguarding patients and products throughout their life cycle.

Pharmacovigilance ensures that medicines remain safe and effective once they reach patients. From individual case assessments to aggregate signal detection, regulatory reporting and supporting non medically qualified QPPV, expert medical input is essential to interpret data accurately and communicate findings responsibly.

Core activities include:

  • Medical review of Individual Case Safety Reports (ICSRs) for causality and seriousness.
  • Supporting QPPV with medically qualified input
  • Support signal detecting activities and evaluate potential signals medically
  • Evaluation of cumulative safety data, trends, and emerging safety signals.
  • Contribution to regulatory reports such as Annual Safety Reports (ASR) and Periodic Safety Update Reports/Periodic benefit-risk evaluation report (PSURs/PBRER).
  • Collaboration with cross-functional safety teams and external partners.

Value to client

Cornelia offers focused, physician-led pharmacovigilance support — combining clinical judgment with regulatory precision. Her independent reviews help sponsors and CROs maintain compliance while ensuring that safety decisions remain clinically sound and defensible.

Safety Committees

Independent expertise for structured, evidence-based safety governance.

Safety Committees and Data Monitoring Committee/Data Safety Monitoring Boards (DMC/DSMB) provide an essential layer of independent oversight in clinical research. They assess accumulating safety and efficacy data, guide sponsors on study continuation, and help manage emerging risks in an objective and transparent way.

Core activities include:

  • Serving as independent physician or voting member in Safety Committees and DMCs.
  • Reviewing interim safety and efficacy data against stopping rules and predefined criteria.
  • Contributing to or chairing Safety Committee meetings and discussions.
  • Supporting the development of Committee Charters (writing and reviewing)
  • Providing expert interpretation and recommendations to sponsors and CROs.

Value to client

With deep clinical and regulatory insight, Cornelia ensures that Safety Committees operate with rigor, integrity, and clarity. Her structured approach supports balanced benefit-risk evaluation and strengthens the sponsor’s commitment to ethical, patient-centric research.

Every clinical program deserves experienced medical oversight that protects participants, strengthens data, and satisfies regulators. CLT Vigilance Consulting provides that assurance — combining clinical perspective, regulatory discipline, and independent judgment.