Medical Oversight Supporting Patient
CEBIS can coordinate medical oversight with clinical operations and pharmacovigilance to support review of clinical and safety matters arising during study conduct.
The level of medical-monitoring support can be aligned with the protocol, participant population, study phase and sponsor requirements.
Clinical Context
Throughout Study Conduct
Clinical studies can generate medical questions and safety information that require review in the context of the protocol and participant population.
Medical monitoring provides a clinical point of coordination for these issues and can support communication between investigators, the sponsor and relevant study functions.
Key areas can include:
- Protocol-related medical questions
- Participant-safety considerations
- Review of relevant clinical information
- Medical issue escalation
- Coordination with investigators and study teams
- Alignment with pharmacovigilance
Supporting Clinical Questions
Study protocols define participant eligibility, clinical assessments, safety requirements and study procedures.
Medical monitoring can provide clinical input when study teams encounter questions requiring medical interpretation or escalation.
Protocol Questions
Support clarification of clinically relevant protocol requirements.
Eligibility Questions
Provide medical input where participant eligibility requires study-specific interpretation.
Clinical Assessments
Support review of clinically important information where escalation is required.
Investigator Communication
Maintain an appropriate pathway for medical questions originating at participating sites.
Clinical Review Connected to Safety Processes
Medical Monitoring
Clinical context
medical review
study-team communication
escalation
Pharmacovigilance
Case processing
safety documentation
reconciliation
regulatory safety activities
Connecting Site Safety Information
Safety Information Identification
Safety information originates through the clinical study and participating sites.
Clinical Review
Relevant medical questions or clinical context can be escalated for review.
PV Coordination
Safety information is transferred into the agreed pharmacovigilance workflow.
Follow-Up
Additional information can be requested through the appropriate study channels.
Reporting
Formal reporting activities are managed according to the applicable PV and study process.
A Clear Path for Clinically
Important Questions
Clinical teams need to know where medically important questions should go and how significant issues are escalated.
An appropriate medical-monitoring model can help establish:
- Defined medical communication pathways
- Clinical issue escalation
- Coordination with investigators
- Communication with Project Management
- Alignment with safety teams
- Documentation and follow-up of relevant issues
Need Medical Monitoring or Safety Support?
Tell us about your study phase, participant population, protocol, countries and medical or safety requirements. A member of the CEBIS team can discuss the appropriate support model.