As part of our suite of clinical trial solutions, OmniComm offers TrialMaster Safety as its pharmacovigilance database. Linked to our TrialMaster EDC Solution, TrialMaster Safety accommodates both MedDRA dictionary and customized client dictionaries and is HIPAA and 21 CFR Part 11 compliant.
TrialMaster Safety provides for the coding and storing of SAE information either in a manually entered mode directly into a web-based form or automatically from event-driven information from a clinical study EDC system such as TrialMaster. The import module is vendor-independent and can be configured to accept other sources of SAE information than those from a clinical study or OmniComm's TrialMaster.
The pharmacovigilance database:
- Provides inventory tracking of trial components and automatic notifications when certain trigger events occur.
- Generates electronic Data Clarification Forms (DCFs) / queries to assist faster case closure.
- Generates client-requested reports, including Investigator notification of expedited safety reports.
- Generates and pre-fills MEDWatch forms for US reporting or CIOMS forms for reporting in the rest of the world.
- Allows electronic reporting of SUSARs and generates listing for annual safety reports in compliance with the European Union Clinical Trials Directive.
- Allows for optional use of TrialMaster's powerful Ad-Hoc reporting tool that offers end-users the ability to develop custom analysis and reports. Ad-Hoc can be integrated into the TrialMaster Safety application, providing a powerful analysis tool for clinicians and or Sponsors. By providing this functionality, the end-user is able to query any data variable or group of data contained in the database and can generate and save custom reports, including charts and graphs, with little knowledge of the underlying databases.
- Designed to allow additional operational modules to be added going forward with minimal impact to existing data structures.
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