Medical Monitoring
Pre-Study Consultation & Planning
As part of DVCR’s full-service offerings, the team strives to provide a seamless and fully customizable approach to Medical Monitoring. From the development of the protocol synopsis through the finalization of the Clinical Study Report, a dedicated member of the team will offer personalized service to all stakeholders as determined by sponsor preferences. The scope of services will be tailored to the sponsors needs and will be formalized in the Medical Monitoring Plan.
Pre-Study Consultation & Planning
As part of DVCR’s full-service offerings, the team strives to provide a seamless and fully customizable approach to Medical Monitoring. From the development of the protocol synopsis through the finalization of the Clinical Study Report, a dedicated member of the team will offer personalized service to all stakeholders as determined by sponsor preferences. The scope of services will be tailored to the sponsors needs and will be formalized in the Medical Monitoring Plan.
Study Development Activities
Sypnosis and Protocol Design
Consultation on patient selection, endpoint determination, feasibility assessment and site selection.
Medical Monitoring Plan Development
A comprehensive template is the starting point which allows for rapid creation and customizations.
Investigator & Team Training
If indicated, development of protocol-specific education plans and materials for investigators, study monitors and site personnel.
Regulatory & Sponsor Collaboration
Active participation in investigator meetings, safety review committees and regularly scheduled Project Management meetings.
Oversight of Study Conduct
- Medical Eligibility: Ongoing assessment of patient eligibility for enrollment and continued participation.
- 24/7 Medical Support & Safety Oversight: Telephonic access to MM for investigator inquiries, protocol deviations, unblinding decisions and urgent medical concerns.
- Primary Contact for Investigators: Direct medical support for Principal Investigators (PIs) and site teams regarding protocol interpretation and patient management.
- Safety Monitoring: Medical review of critical lab values, safety signals and subject well-being throughout the trial.
- Serious Adverse Event Management: Thorough review of all reported Serious Adverse Events to include review of narratives, safety data and supplemental medical records required for timely reporting.
- Guidance on Medications & Concomitant Conditions: Expert recommendations on prohibited medications, drug interactions and underlying health conditions.