Rho's Product Safety Department provides timely and accurate Serious Adverse Event (SAE) reporting in compliance with all applicable regulatory requirements and ICH GCP Guidelines. Our safety team is composed of medically trained safety professionals with comprehensive expertise in pharmacovigilance; our experience spans early phase I studies through post-marketing studies.

In compliance with Rho's standard of high quality, Product Safety offers the following services to our Sponsors:

• Complete, timely Serious Adverse Event (SAE) management and handling
• Expedited reports (MedWatch/CIOMS forms)
• Developing flexible, validated safety databases compatible with Sponsor specifications
• Writing medically sound adverse event narratives
• Qualified medical review of all Serious Adverse Events data and narratives for completeness and medical sense
• MedDRA coding of SAEs
• Protocol, CRF, and investigator brochure review
• SAE report form development
• Contracted medical monitoring of expedited reports and review for trends
• Sponsor access to safety data through status reports, access to defined areas of the safety database, and/or inclusion in the safety process
• Production of SAE listings for regulatory documents such as Annual Reports and Periodic Reports (PSURs)
• Maintenance of product safety profile from clinical development through the lifecycle of the product