Genius VIGILANCE™ – Safety Report & Management
Timely and accurate safety reporting is critically important in clinical research. In addition to ensuring safety of clinical trial participants, systematic capture and analysis of safety data from clinical trials is important for developing the safety profile of the drug and contributing to its benefit-risk assessment, which is a key consideration in the approval decision.
Genius VIGILANCE™ allows for the automatic transfer of specific data from Genius eCRF™ to the corresponding eSAE report so that the physician can meet his statutory reporting duties with just a few clicks. The sponsor receives high-quality and complete data and needs to spend less time on the follow-up (FU).
Genius VIGILANCE™ eSAE reporting solution main benefits
- Entered SAE data as well as other relevant information from other areas of Genius eCRF™ (e.g., demography, medical history, concomitant medications…) are sent directly to the Pharmacovigilance (PV) department in the form of a PDF SAE Form
- eSAE report form could be customized to Sponsor’s template
- Study sites no longer have to fill out forms twice (paper SAE, eSAE form)
- The sites’ motivation to fill out the eSAE form correctly increases, as does the completeness and data quality of the SAE reports
- Immediate mail notification of a new eSAE report availability
- Regular reconciliation and alignment between the safety database and the study AE database
- Faster case processing timelines
- Electronic submission of ICRS XML reports to EudraVigilance and FDA according to ICH E2B (R3) message standard
- Automated generation of CIOMS and MedWatch forms
- MedDRA and WHO dictionaries coding availability