Our highly experienced clinical research physicians
provide medical expertise to evaluate the safety and
conduct of a clinical trial. Their support safeguards the
success of a clinical trial through delivery of high
quality clinical data to our customers.
We provide the following services:
- 24-Hours/7-Days Serious Adverse Event (SAE) reporting and medical coverage
- Preparation of narratives, Medwatch and CIOMS reports
- Review of potential subject eligibility
- Medical review of adverse events, labs, vital sign, ECG's, and any other study related datasets
- Answer investigational product/protocol related questions
- Review of Case Report Form design
- Medical support to clinical sites, clinical research associates, clinical data managers and project teams
- Coding of adverse events, concomitant medications and other study related data
- Medical review of all clinical trial related documents i.e. clinical study reports, etc.