CROMSOURCE understands the need of many sponsors to have medically qualified clinical research experts leading various aspects of their clinical research.
The CROMSOURCE team of medical monitors comprises physicians with many years of industry and appropriate therapeutic experience who are able to provide expert levels of oversight to areas including:
- Interaction and representation with EU and US Regulatory Agencies
- Clinical Investigation Plan design and writing
- Subject eligibility verification
- Clinical Investigation Plan deviations
- Serious adverse event review and reporting