Let’s take a look at some software used in Pharmacovigilance for the management and reporting of Adverse events. Some software’s used in pharmacovigilance are: -Oracle Argus Safety -ArisG -Oracle Adverse Event Reporting System (AERS) -ClinTrace -PvNET -repClinical -Vigilanz Dynamic Monitoring System -WebVDME Pharmacovigilance Signal detection and Signal management software -PV works

1. MAULANA AZAD'S EDUCATIONAL TRUST'S
Y.B CHAVAN COLLEGE OF PHARMACY,
AURANGABAD
TOOLS/SOFTWARES USED IN
PHARMACOVIGILANCE Prepared By,
Atharva S. Kasegaonkar
Roll. No : 49
1st Year M.Pharm (2nd Semester)
Department of Pharmacology
Subject : Clinical Research & Pharmacovigilance
Guided by : Dr. Dureshahwar Khan Mam

2. DEFINITION OF PHARMACOVIGILANCE :
According to WHO - Pharmacovigilance is the science and activities
relating to the detection, assessment, understanding and prevention of
adverse effects or any other medicine/vaccine related problem.
It deals with :
• Identifying new information about hazards associated with medicines
• Preventing harm to the patients

3. SOFTWARES USED IN PHARMACOVIGILANCE :
Let’s take a look at some software used in Pharmacovigilance for the
management and reporting of Adverse events.
Some software’s used in pharmacovigilance are:
• Oracle Argus Safety
• ArisG
• Oracle Adverse Event Reporting System (AERS)
• ClinTrace
• PvNET
• repClinical
• Vigilanz Dynamic Monitoring System
• WebVDME Pharmacovigilance Signal detection and Signal management
software
• PV works

4. Softwares like Argus, ArisGlobal, and PvNET are used in
Pharmacovigilance. VigiFlow, VigiBase used in post marketing
surveillance
VigiBase is a WHO’s global Individual Case Safety Report (ICSR)
database that contains ICSRs submitted by the participating member
states enrolled under WHO’s international drug monitoring programme.
Uppsala Monitoring Centre (UMC) in collaboration with ‘’Swissmedic’’
has developed ‘’VigiFlow’’, a web-based ICSR management
system. VigiFlow functions as a national ICSR database management
system and analysis tool, through which cases are sent to UMC.

5. ORACLE : ARGUS SAFETY DATABASE :
• Oracle Argus is a market leading pharmacovigilance database. The
main features of Argus database include global case processing, signal
detection, detailed analytics, electronic case intake and electronic
expedited reporting in both E2B(R2) and E2B(R3) formats, risk
management, periodic reporting and submissions; as well as the
capacity to hold large volumes of cases.
• Defining features for Oracle Argus safety database include its long
history in the pharmaceutical industry, brand awareness and
configuration options. It is one of the more complex systems available
and therefore it is better suited to large pharma companies with high
volumes as safety data and with the resources to invest in its
implementation and maintenance.

6. • Argus Safety’s advanced database helps ensure global regulatory
compliance, enables sound safety decisions and integrates safety and
risk management functions.
Oracle Argus Safety – Key Features and Benefits :
Oracle Argus Safety has the following features:
• Origination of cases via case entry screens
• Tracking of local data items
• Support for e-signatures
• Duplicate search capabilities
• Local labelling decisions made against local data sheet or license
• Case views provided to appropriate local affiliate

7. • Ability for several affiliates to simultaneously view and make
local labelling calls against the same locked case
• Views of core documents and global protocols such as action items on
a work list.
• Central staging area for reviewing submitted affiliate cases
• Electronic submission capabilities
• Querying and reporting cases received and submitted
• Audit Trails
The benefits of using Oracle Argus Safety include:
• Improve data safety with a single case management database
• Realise immediate ROI by streamlining and integrating affiliate
business processes

8. • Increase worker productivity by eliminating redundant data entry
• Reduce risk by allowing central safety group to accept or reject cases.
Advantages of Oracle Argus Safety :
• Ensures Global Regulatory compliance - Organisations must ensure that they are
compliant with global regulations and guidelines, including those of EMEA,
FDA, ICH and a myriad of national authorities. Companies depend on Argus
Safety to help manage their regulatory compliance requirements in a timely and
proactive manner. It enables full compliance and can lower the cost of regulatory
reporting.
• Offers Better Data Insights and Faster decision making - The system is designed
for fast safety data entry. Advanced functionality such as dynamic workflows,
wordlist management, company-defined reporting rules and extensive
automation are incorporated to ensure maximum case processing efficiency.

9. • Oracle Argus Safety – Integrates Safety and Risk Management
Argus Safety is a complete platform designed to address the industry’s end-to-end
safety and risk management needs. it includes a comprehensive tool set for
expedited and periodic reporting, capability for clinical trial SAE reconciliation and
partner Adverse Event management.
• Oracle Argus Safety – Industry Proven and Accepted
Argus Safety has been used for over a decade at some of the industry’s leading
companies, including global pharmaceutical, Biotech, CRO and medical device
manufacturers. It is continuously enhanced through a defined and planned product
roadmap.

10. ARIS GLOBAL (ARISg)
• ArisGlobal’s/LifeSphere Safety (otherwise known popularly as
ARISg) is another market-leading pharmacovigilance database with a
long and well-established heritage in the industry. It provides
comprehensive suite of functionality and tools as well as additional
modules and interfaces covering other aspects of pharmacovigilance
as well as regulatory, medical affairs and clinical solutions.
• ARISg is also one of the most used software in pharmacovigilance
used by pharmaceutical companies. It is used by more than 300
companies that maintain their critical drug safety data in ARISg
worldwide.
• ARISg provides all the functionality required to manage adverse event
reporting and adverse reaction requirements of different regulatory
authorities around the world.

11. • It allows for all pharmacovigilance processes from case entry to
automatic generation of submission ready adverse event (AE) reports
including CIOMS 1, MedWatch 3500A and many more.
• ARISg forms a core component of an integrated pharmacovigilance
and risk management system, enabling companies to monitor their
products and identify safety risks proactively.
• ARISg helps speed up the management of Adverse Drug reactions
with the use of its configurable workflow and advanced automation
features.
• Users can setup a system that meets their business process and
standard operating procedure (SOP) requirements more efficiently by
automating the routing of cases as defined in their workflow rules.
• As with all Aris Global products, ARISg is available on premise and
on demand versions.

12. VIGIFLOW
• VigiFlow is a web-based individual case safety report (ICSR)
management system that is available for use by national
pharmacovigilance centres of the WHO Programme for International
Drug Monitoring.
• VigiFlow supports the collection, processing and sharing of data of
ICSRs to facilitate effective data analysis.
• VigiFlow is compliant with the international ICH E2B standard and
maintained by UMC in Uppsala, Sweden. VigiFlow is available to
national pharmacovigilance centres, but it is not mandatory to use for
reporting to VigiBase.
• UMC charges a licence fee for VigiFlow, determined by the World
Bank Atlas method.

13. History of Vigiflow :
• Vigiflow was initiated in the year 2001, when Swiss Medic required a
new Pharmacovigilant Body.
• Vigiflow was created with name – ADR PLOT
• It was supported with primary reporting facility 7 regional centre in 4
languages.
• The first reporting was done in year 2003 at Ghana.
Vigi flow includes :
• Data entry
• Assessment
• Storage
• Retrieval
• Communication with other parties

14. Creating/ Inputing a new report in Vigiflow:
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.
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.

15. 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
• 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
• 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.

16. • 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).​

17. Vigiflow Interface : Flow of Reports in Vigiflow :

18. 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.

19. Statistical Methods for Evaluating Medical Safety Data :
Regulatory agencies like the FDA and International organizations like the
WHO usually monitor the safety profile of all the drugs in their
respective databases which could mean analyzing thousands of possible
AEs for thousands of drugs. No doubt, screening of large databases of the
spontaneous case reports on possible AEs is cumbersome. Therefore, they
rely on very complex data mining techniques to facilitate signal
detection.
In general, the commonly used statistical methods are:
• Bayesian Confidence Propagation Neural Network (BCPNN),
• Empirical Bayesian Geometric Mean (EBGM)
• Proportional Rate Ratio (PRR), and
• Odds Ratio (OR).

20. THANK YOU...