Ensuring subjects safety, rights and compliance with trial protocol and GCP are crucial to the success of a study.
ABX-CRO offers experienced, comprehensive Medical Monitoring covering all phases of a clinical program.
An ABX-CRO Medical Monitor provides medical expertise, oversight, and consultation before and during a clinical trial. They are qualified, licensed physicians with extensive experience in patient care and specialized training related to clinical research and the pharmaceutical industry.
Our Medical Monitors oversee safety and rights of trial subjects and correct clinical evaluation from initial design to study report. As part of the core clinical project team they act as point of contact for site staff, study team and sponsor.
- Consultation on study design, including patient selection, endpoint determination, feasibility assessment and site selection
- Development of study concepts, trial protocols and observational plans
Review of core documents & data
- Review of protocol, IB, ICF, eCRF, subject diaries and subject card
- Review of medical coding
- Review of CSR, aggregated safety reports
Monitoring of Patient Safety
- Central review of safety related listings, e.g. laboratory results, AEs
- Review of safety signals
- Medical review of CIOMS forms
- Review and grading of protocol deviations
Monitoring of regulatory adherence
- Management of/Advice for „Supected Serious Breaches“
- Close co-operation with pharmacovigilance
Advice to sites and study team
- Support with protocol related questions
- Indication training of project team
- Presentation/Training at Investigator’s Meeting
- 24/7 availability for emergency unblinding
Management of Data Review Committees
- Set-up and management
- Supervision/Writing of report
- Data presentation at meetings
- Support with decisions related to efficacy/dose escalation