We provide exceptional prowess at each stage of case processing:
- Data Entry
- Quality Review
- Medical Review
The modular design of our offerings allows the selection of individual services or an end-to-end solution for adverse event reporting and management in the early clinical trial phases to post-marketing surveillance.
Our specialists have proficiency in Argus, ARISg/LifeSphere Safety, and other safety databases.
We enhance our ICSR management capabilities by providing the following services:
- Medical information call center (MICC) management
- Safety literature searches for identification of ICSRs
- Automated tracking of open and missing cases
- Monitoring of expedited reporting and reporting of submission status
- Submission of serious adverse event reports to health authorities
- Quality assurance
- E2B case reporting & archiving