SafetyDrugs is the pharmacovigilance software system that supports the capture, management, reporting and analysis of adverse events from clinical trials and from post marketing surveillance, including cases from literature, of all medical products: from drugs to devices, from vaccines to cosmetics.
The database is powered by Oracle, our technological partner, leader in Relational Database Management System.
The software, produced and developed by Max Application, has been developed in compliance with the ICSR ICH (R3) and EMA and FDA exceptions.
What SafetyDrugs does
SafetyDrugs is easy to install and user-friendly, is a completely customazible software to user needs, from the workflow to the user parametrization. It is able to manage different company sites or different customers for Service Providers or different Cinical Trial for CRO and its modular structure allows easy future alignments with regulatory requirements.
Our pharmacovigilance software is one of the most cost effective products on the market. SafetyDrugs is infact leader of safety Italian databases in the domestic market. The 23% of Italian pharmaceutical companies use SafetyDrugs for the management of adverse events in a way safe and compliant with ICH, FDA and EMA rules.
To support pharmaceutical companies to easily obtain Computer System Validation, in accordance to GAMP5 guidelines, we provide also an accurate and complete Validation Kit. This document set ensure a quick and a cost effective start-up allowing SafetyDrugs to get ready to use in few days.
The Database generates the following reports:
- Pregnancy form
- PSUR (line listing, summary tabulation, work sharing)
- PBRER (cumulative Adr(s))
- DSUR (line listing, summary tabulation)
- Standard MedDRA Queries (line listing, summary tabulation)
- Quality Check Report
- Cover report and other customizable listings for inspective purposes.
The system is fitted with the following tools:
- Gateway, for the ICSRs automated and secure transmission to authorities and partners
- Report generator, to allow the customization of report based on templates, set by the user
- Message System, to send alerts, reminders and email, with attachments with customizable settings
- Backward and Forward Conversion Tool (BFC)
- WHO and MedDRA dictionaries supporting
- Search for duplicates, that allows to launch parametric search for duplicates
- Audit trail, with additional possibility to setting the parameters
The software offers the following funcionalities:
- Import and export of electronic reports both in XML and HL7 file forrmat
- Selective Import, that allows the batch acquisition of HL7 files with relative preview mask prior to import for triage purposes
- SMART data entry mask, for a quick data entry of the case on a single mask
- Action Items, for help the management of any activity scheduled
- Transparent data encryption during both storage and transmission
- Interaction with Windows tools (Word, Excel, Acrobat, etc..)
SafetyDrugs allows companies to be compliant to ICH, FDA and EMA rules:
- FDA 21CFR part 11
- FDA Guidance for Industry: Computerized System used in Clinical Trials
- ICH topic E6 Guideline for Good Clinical Practice
- ICH ICSR (R3) Electronic Transmission of ICSRs.
SafetyDrugs is equipped with an its own Business Intelligence software integrated to the database. It allows to carry out detailed analysis, through intuitive graphs, charts and pivot tables, and to create one's queries models. The Signal Detection analysis is included in the module and provides statistics that show the evidence of adverse events with disproportionally high statistical scores.
SafetyDrugs is also available in SaaS modality, Software as a Service. It guarantees software updates included in monthly fee, data security defined by PLA (Privacy Level Agreement), the high top security standards of the data centres that host data (UNI EN ISO 9001 and 27001) and finally the almost synchronous Disaster Recovery service.