ADR reporting Tools Used In Clinical research and Pharmacovigilance 1 Vigiflow 2 Argus-G 3 Aris

1. ARGUS, ARIS-G AND VIGIFLOW
Naveen K L
Dept of Pharmacology
Srinivas College of Pharmacy
Valachil, Mangalore

2. • Oracle Argus is the market leading solution for processing, analysing,
reporting an adverse event cases originating in Pre and Post marketed
drugs, biologics, vaccines, devices and combination products.
• Its an Pharmacovigilance safety database used to keep any of the PV safety
database up to date with the latest regulatory requirements and validated
to meet both international standard and business requirements.
• The main features of Argus database includes Global case processing,
Signal detection, Detailed analytics, Electronic case intake and Electronic
expedited reporting in both E2B (R2) & E2B(R3) formats, Risk management
periodic reporting and submission

4. How Does Argus Help?
• Supports fast and effective data entry from global partners.
 Model-1: Partner have direct access to a central argues instance via
corporate network.
 Model-2: Argus local affiliate module allows local case entry, labelling and
reporting plus central repository synchronisation.
• Supports fast and effective distribution of cases and appropriate reports to
the global partners users.

5. Globalised Case Processing Model-1
Certain case data can be
entered in local language
Case are placed into work list and assigned
to global group to keep the case process
Central repository of global reports rules
allows for the tracking of submitted reports
Periodic reports are maintained in a central
screen that allows clear tracking and
compliance auditing

6. Globalised Case Processing Model-2
Subset of case data can be entered into a local affricate
module (LAM) even in local language, if required
Cases are transferred to the central repository for review and
global partners are notified when local labelling or reporting is
required
Local work all occur in the LAM
Central repository of global reports rules allows for
the tracking of submitted reports
Periodic reports are maintained in a central screen
that allows clear tracking and compliance auditing

7. • Aris-G is a leading PV and clinical safety system.
• Enables companies to reduce safety risk for multiple product types including
drugs, devices, vaccines and combination products.
• Provides international safety reports for clinical and Post marketing
surveillance.
• Improves the case processing life cycle and reduces data entry time.
• Automates case processing and reports distribution with feasible workflow.
• Shortness the medical review and coding process .
• Integrates with documents management system, business objects and clinical
system.
• Aris-G is a comprehensive adverse event management system and manages
reports from all potential sources.

8. Case Querying and Analysis
• Creates a complex of queries and supports of the published Med-
DRA;SMQ.
• It performs:
Case review
Runs batch operation
Validation
Case updates
Reporting
Users to view or represent data in the form of charts

9. Key Features:
• Role based data entry forms allows for fast and efficient processing of
received adverse event data.
• A Med-DRA browser.
• Case assessment summary screen shows all key case information, while
allowing the assessor to add specific case information.
• Extensive regulatory and management reporting capabilities including a
suite of expedited and aggregate reports, management reports.

10. Vigi Flow – Medical Data base
• Introduction:
 Vigiflow is international web based report management tool for report
management.
 It is a complete, easy management system for ICSR – Individual Case Safety
Reporting.
 Vigiflow can be used by any authority or company as a database for report
management and data analysis.
 Vigiflow is not primarily a tool of UMC- Uppsala monitoring Center , But the
data can be transferred to UMC.

11. HISTORY:
• Vigiflow was initiated in the year 2001 when , Swiss medic required a
new Pharmacovigilant body.
• Vigiflow was created with a name “ ADR Pilot”.
• It was supported with primary reporting facility , 7 regional centers ,4
languages.
• The first reporting was done in year 2003 at Ghana

13. Data flow in Vigiflow:

14. Creating a new report :
Once we load to new report option , there are 2 sub options
• Standard case :
In a standard case, cases with ADR , ADE , Side effects, Drug reactions or
reaction due to possible drug administration etc..
• Parent-child case :
A parent-child case is filled when the child is suffering from an ADE / ADR
due to the medication taken by the parent.

15. General Reporting:
General reporting can be done by Regional centers. It consists various
important sections to be filled in.
Senders information :
In the senders info, various mandatory sections like Fillers name , address ,
Designation , Fill in date , time and location .

16. Report Information :This contains details about the event
• Patient details - Name / initials , Birth date / Age / Age group , Weight,
Gender .
• Tests and procedure
• Relevant medical history

17. • Current / past drug therapy – This contains any drug treatment in the
current or past times. This section must be filled with details like
 Drug name
 Indication( if any, provided in drug literature)
 Reaction observed

18. • Reaction observed – Reactions , List of coded reactions , causality
assessment , Onset of reaction , End time of the reaction , Duration of the
reaction, outcome of the reaction, details of any treatment given to
counteract the reaction , drug ,dose .

19. • Drugs consumed :
List of drugs given as a treatment for the reaction , drug name , dose .
• Assessment given
Assessment can be either be either physically or therapeutically.
• Overview of the case
This is a free text which includes case narrative , sender’s comment , sender’s diagnosis ( in
codes a/c to Med-DRA or ICD10.

21. Pro’s & Con’s
Pro’s
• Free text fields providing complete data entry
• Integrated dictionaries which helps correct coding.
• Easy and constant connection between regional and national servers.
Con’s
• Server of a different country might give a glitch in uploading.
• Needs faster internet server.
• Unless the case is filled and

22. Thank You!