Medical and Safety Monitoring
Our medical and scientific team members have experience in the biopharma and
CRO industry – as well as direct experience as practicing physicians.
At Cmed, our medical monitor coverage is designed to assist sites with
study-related questions including safety reporting issues; discussions regarding
inclusion/exclusion concerns and deviations; safety trending analysis; and
patient management questions.
The Cmed medical team provides insight into clinical practice at all phases
of study conduct:
- Provide protocol input; review protocol and
electronic case report forms (eCRFs).
- Aid in study design, in collaboration with
external consultants and sponsor as required.
- Conduct Investigator/Key Opinion Leader (KOL)
recruitment, communication and management.
- Review safety monitoring plan and statistical
analysis plan to provide insight.
- Address site initiation and enrollment issues.
|Ongoing trial activities
- Be available 24⁄7.
- Conduct frequent calls to investigators throughout
trial to ensure site remains at a “steady state”.
- Actively work with clinical research associates
(CRAs) and project managers on day-to-day patient
care and medically relevant study conduct issues to
ensure the trial runs as smoothly as possible.
- Assist sites with inclusion/exclusion criteria
- Assess need for protocol amendments.
- Collaborate with sponsor medical and
- Review lab reports, safety reports and protocol
- Development of safety reporting.
- Overview and review of Clinical Study Report
Cmed’s eClinical technologies enable the team to quickly
monitor and react to any medical issues from the clinical study, allowing Cmed
to keep you informed at every step.