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:

 

Start-up activities

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 questions.

Assess need for protocol amendments.

Collaborate with sponsor medical and pharmacovigilance teams.

Review lab reports, safety reports and protocol deviations.

Close-out activities

Development of safety reporting.

Overview and review of Clinical Study Report (CSR).

 

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.