Service 03 / 06
Medical Monitoring
Physician oversight of participant safety and protocol integrity.
Overview
Qualified physicians provide continuous medical oversight across your study — reviewing eligibility, adjudicating safety events, and acting as the clinical point of contact for investigators. Medical judgement stays close to the data rather than arriving weeks later in a report.
- Physician review of eligibility and safety events
- A named medical monitor with defined escalation times
- Protocol deviation and eligibility waiver adjudication
Capabilities
What this covers.
Each capability can be contracted on its own or as part of the full service line.
- 01
Protocol Medical Review
Clinical review of protocol design, eligibility criteria and safety monitoring provisions before finalisation, flagging criteria that will not recruit in the intended population.
- 02
Eligibility & Enrolment Oversight
Case-by-case medical review of screening data and eligibility questions, with documented decisions available to the investigator and the sponsor.
- 03
Safety Event Assessment
Medical assessment of adverse and serious adverse events, causality and expectedness opinions, and coordination with pharmacovigilance for expedited reporting.
- 04
Investigator Medical Support
A named medical monitor available to investigators for urgent clinical questions, with defined response times for safety-critical calls.
- 05
Data Review & Trend Detection
Ongoing medical review of aggregated safety and efficacy data to surface trends, dosing signals and site-level anomalies while there is still time to intervene.
- 06
Committee Support
Preparation of medical narratives and data packages for Data Safety Monitoring Boards and adjudication committees.
Deliverables
What you receive.
Concrete artefacts on an agreed schedule — so progress is verifiable rather than asserted.
- Medical monitoring plan
- Documented eligibility and deviation decisions
- Causality and expectedness assessments
- Patient safety narratives
- Aggregate safety trend reviews
- DSMB data packages
Related services
Often engaged alongside this.
Next step
Scope a medical monitoring engagement.
Share your protocol synopsis and target timeline. We come back with scope, assumptions and an indicative budget.