SafetyDrugs is a Pharmacovigilance Software for the management of adverse events from drugs, devices and clinical trials compliant with ICH, EMA and FDA rules.
Business Intelligence and Signal Detection modules can be added to perform drilldown analysis.
Easy to install and very user-friendly, Software validation documents set provided.
2. • A web-based software developed by Max Application
• Allows biopharmas to keep their own database of Adverse Events reports
• Manages Adverse Events
• Spontaneous
• Literature
• Report from study (Clinical Trial,Observational…)
• Post-marketing
• Regulatory Authority
• Compliant with Eudravigilance and FDA rules
ABOUT SAFETYDRUGS
3. • Disaster Recovery
• Hosted by
• Direct upload to EV
• Transmission by email of files in XML format
• Business Intelligence
• Developed using Oracle case ®
OTHER RELEVANT FEATURES
4. • Easy to use
• AE Adverse Events of drugs, devices, vaccines, biologics and cosmetics
• AE related to post marketing surveillance, literature, clinical trials
• SaaS (Software as a service) or Purchasing
• Fast installation: get started in few days
• Customizable to user needs
• Good price / quality ratio
• Complete technical documentation
• Continuous software update
SAFETYDRUGS BENEFITS
6. What you can manage Services to clients
Literature
Import from XML / Multi Media Data
Data Entry
Alert system
B.I. / Signal Detection
Cosmetics
MedDev MedWatch
AE Form
Regulatory reports
email
EV/FDA
PDF / XLS from RNF-AIFA
XML Product import from
XEVMPD
7. SERVICE SITE
SafetyDrugs Database can manage different sites.
Each site can represent:
• Country = Multinational Pharmaceutical Company
• Client = CRO
• Clinical Trial = Pharmaceutical Company
• Each environment independent
• Security and Privacy
• Customizable analysis
• Main company access
Site 1
Site 2
Site 3 …etc
8. EXAMPLE OF WORKFLOW (Parametric for site)
NEW CASE
(case version 1)
CASE DATA ENTRY
QC REVIEW
Follow-up
information
(new case version)
Follow-up
information
(new case version)
MEDICAL ASSESSMENT
Report Generation
(Final)
Report Generation
(Draft)
Report Generation
(Final)
Submission
Status: Controlled
Status: Open
Status:
Assessed
Reportable
Status:
Assessed non
Reportable
Status: Submitted
END CASE DATA ENTRY
9. How does it work?
• You receive the case in PDF format
• You simply insert the case in our converter SDConverter
a. All the relative charts are filled out
b. The descriptions of the reactions are converted into the correspondent MedrDRA code
c. Medicines, active substances and methods of administration are inserted
d. The units are transformed in E2B codes
e. Is possible to create in automatic a customizable narrative
SDConverter gives you the chance to create, send by e-mail, save and print the following reports: CIOMS,
XML, AE form e customizable report.
IMPORT CASES FROM RNF-AIFA
10. VALIDATION KIT
To simplify the validation process MaxApplication proposes a complete and accurate technical
documentation set (compliant with GAMP5® guidelines). This set will help your company during
the entire validation process.
The Validation Kit contains:
STANDARD MARKET REQUIREMENTS:
• Standard parameterization
• Standard coding tables
• Standard workflow
PROVIDED DOCUMENT FOR VALIDATION SUPPORT:
• QPP – Quality and Project Plan
• RAR – Regulatory compliance
• FS – Functional Specification
• DS – Design Specification
• UIT – Unit and Integration Test
• TM – Traceability Matrix
• IP – Installation Procedure
11. ALERT SYSTEM
a. The system displays the alert status in different colours
Black = ‘Serious’
SEND ALERT/STATUS
b. SafetyDrugs generates an alert message
• Different Alert Messages for each Site
• Different Alert Messages for expiring and expired time
• Different Alert Time for each country
Receiver List (To/Cc/Ccn)
c. Transmissions can be sent in batch modality
12. BUSINESS INTELLIGENCE
The Business Intelligence supplies a flexible tool for queries and data analyses.
The main features of SafetyDrugs® B.I. :
• Adverse Events data warehouse
• Graphics and intuitive navigation
• Visualization: data can be showed using dashboards and graphic tools
• Drill down analysis
13. SIGNAL DETECTION DASHBOARD
Analysis of the selected DRUG or selected EVENT with :
• Events -> Drug detail / Drug -> Event detail
• Graphical expression of PRR
• Confidence Interval, Chi square, p-value
14. We are at your complete disposal for further information.
Best regards
Max Application srl
Via Nazario Sauro 4 – 13900 Biella (BI)
ITALY
Tel. + 39 (0)15.32.468
Mail marketing@safetydrugs.it
www.safetydrugs.it