ABSTRACT

Pharmacovigilance is a critical field in ensuring drug safety and efficacy by

monitoring and evaluating adverse drug reactions (ADRs) and other drug-related
problems. It involves the collection, analysis, and interpretation of data from various
sources, including healthcare providers, patients, and clinical trials. The goal is to
identify new information about drug hazards, prevent harm to patients, and improve
overall drug safety.

Key Components of Pharmacovigilance

 Adverse Event Reporting: Collecting reports of adverse events from healthcare

professionals, patients, and manufacturers.
 Signal Detection: Identifying patterns or signals that indicate potential safety
issues with drugs.
 Risk Management: Developing and implementing strategies to mitigate
identified risks.
 Regulatory Compliance: Ensuring adherence to legal and regulatory
requirements for drug safety monitoring.
 Data Analysis: Using statistical and computational techniques to analyze adverse
event data and identify trends.

Common Pharmacovigilance Software

 Oracle Argus Safety: A comprehensive pharmacovigilance software suite that

supports the entire lifecycle of safety case management. It includes advanced
analytics and reporting capabilities for detecting safety signals and managing
adverse event data.
 ARISg: A software tool for managing and analyzing pharmacovigilance data,
particularly useful for signal detection and risk management.
 Oracle AERS: The Oracle Adverse Event Reporting System (AERS) is designed
to collect, manage, and analyze adverse event reports, supporting post-marketing
safety surveillance.
 PvNET: A software platform for managing pharmacovigilance activities,
including adverse event reporting and signal detection.
 repClinical: A software solution for clinical research and pharmacovigilance,
providing tools for data management, analysis, and reporting.
 Pega Pharmacovigilance: This software improves speed, compliance, and risk
management for drug and device safety. It features responsive, multi-channel
intake, automated processes, and expanded visibility for safety data.
 Qualio Postmarket Surveillance: A software solution for postmarket
surveillance and pharmacovigilance, offering automated triggers, detailed
analytics, and integration with third-party tools.
 CONTENT
PAGE
SR NO. TITLE
NO.

UNIT 1 Pharmacovigilance

1.1 Introduction

1.2 History and Evolution

1.3 Types of Pharmacovigilances

UNIT 2 Software used in Pharmacovigilance

2.1 Introduction

2.2 Oracle Argus Safety

2.3 ArisG

2.4 Oracle AERS

2.5 PvNET

2.6 repClinical

2.7 PV Works

2.8 VigiFlow

2.9 PharmaLex

03 Summary

04 References
 UNIT 1
PHARMACOVIGILANCE
1.1. Introduction:
Pharmacovigilance is the pharmacological science relating to the detection,
assessment, understanding and prevention of adverse effects, particularly long term
and short term side effects of medicines. Generally speaking Pharmacovigilance is the
science of collecting, monitoring, researching, assessing and evaluating information
from healthcare providers and patients on the adverse effects of medications,
biological products, herbalism and traditional medicines with a view to:

Identifying new information about hazards associated with medicines

Preventing harm to the patients
Pharmacovigilance starts from the clinical stage and continues throughout the product
life cycle of the drug, mainly divided as pharmacovigilance during pre-marketing
(that is clinical phase) and post-marketing. The process of collection of such
information about a drug begins in Phase I of the clinical trial, before approval of the
drug, and continues even after approval; several post-market safety studies are
conducted, with many made mandatory by drug regulatory agencies around the world.

Pharmacovigilance is particularly concerned with adverse drug reactions, or ADRs,

which are officially described as:

“A response to a drug which is noxious and unintended, and which occurs as doses
normally used…for the prophylaxis, diagnosis, of therapy of disease, or for the
modification of physiological function.”

Pharmacovigilance is gaining importance for doctors and scientists as the number of

stories in the mass media of drug recalls increases. Because clinical trials involve
several thousand patients at most; less common side effects and ADRs are often
unknown at the time a drug enters the market. Even very severe ADRs are often
undetected because study populations are small. Post marketing surveillance uses
tools such as data mining of spontaneous reporting systems and patient registries, and
investigation of case reports to identify the relationship between drugs and ADRs.

Pharmacovigilance Processes:
 Spontaneous Reporting: Spontaneous reporting involves healthcare
professionals and patients voluntarily reporting ADRs to regulatory authorities or
pharmaceutical companies. These reports form the backbone of PV systems,
enabling the detection of safety signals.
 Periodic Safety Update Reports (PSURs): Pharmaceutical companies must
submit PSURs to regulatory authorities at regular intervals. These reports
summarize the safety profile of a drug and any new safety information that has
emerged since the last report.
 Pharmacovigilance Databases: Databases like the WHO Global Individual Case
Safety Reports (ICSRs) database, EudraVigilance (EU), and FAERS (USA) store
ADR data, facilitating signal detection and assessment.
Pharmacovigilance in Clinical Trials:
Pharmacovigilance is integral to clinical trials, ensuring the safety of participants
through:
 Safety Monitoring: Continuous monitoring of adverse events.
 Data Reporting: Reporting safety data to regulatory agencies.
 Risk Management: Implementing risk mitigation strategies

Key Concepts in Pharmacovigilance

 Adverse Drug Reactions (ADRs): ADRs are unintended and harmful effects
that occur at normal drug doses used for prophylaxis, diagnosis, or therapy. They
can range from mild side effects to severe, life-threatening conditions. PV
systems aim to detect and assess these reactions to mitigate their impact on
patients.
 Signal Detection: Signal detection involves identifying new or unknown ADRs
from various data sources, such as spontaneous reports, clinical trials, and
medical literature. Tools like disproportionality analysis and data mining
techniques help in identifying potential safety signals.
 Risk Management: Risk management in PV involves developing strategies to
minimize the risk of ADRs. This includes risk communication, where information
about drug safety is disseminated to healthcare professionals and patients, and
risk minimization measures, like restricted distribution programs for high-risk
drugs.

Role of Regulatory Agencies:

 FDA (Food and Drug Administration): Regulates drug safety in the United
States.
 EMA (European Medicines Agency): Regulates drug safety in the European
Union.
 CDSCO (Central Drugs Standard Control Organization): Regulates drug
safety in India

Challenges in Pharmacovigilance:
 Under-reporting: Many adverse events go unreported.
 Data Quality: Ensuring the accuracy and completeness of data.
 Global Harmonization: Standardizing pharmacovigilance practices across
countries.
 Technological Advancements: Adapting to new technologies and data sources.

Future of Pharmacovigilance:
 Big Data and AI: Leveraging big data and artificial intelligence for better data
analysis and risk detection.
 Personalized Medicine: Tailoring pharmacovigilance practices to individual
patient profiles.
 Patient Engagement: Increasing patient involvement in reporting adverse events
and safety monitoring.
1.2. History and Evolution
1.2.1. Early Beginnings:
The concept of pharmacovigilance began to take shape in the mid-19th century. One
of the earliest recorded incidents that highlighted the need for drug safety monitoring
was the death of Hannah Greener in 1848. She died after receiving chloroform
anesthesia during a minor surgical procedure. This incident prompted investigations
into the safety of chloroform and other drug.

1.2.2. Thalidomide Tragedy:

The real turning point for modern pharmacovigilance came with the thalidomide
tragedy in the late 1950s and early 1960s. Thalidomide, initially marketed as a
sedative and treatment for morning sickness in pregnant women, led to thousands of
birth defects worldwide1. This disaster underscored the critical need for rigorous drug
safety monitoring and led to the establishment of formal pharmacovigilance systems

1.2.3. Establishment of Regulatory Bodies:

In response to the thalidomide tragedy, several regulatory bodies were established to
oversee drug safety. In 1968, the World Health Organization (WHO) launched the
Programme for International Drug Monitoring, which aimed to collect and analyze
data on adverse drug reactions (ADRs) globally1. This program laid the foundation
for international collaboration in pharmacovigilance.

1.2.4. Evolution of Pharmacovigilance System:

Over the decades, pharmacovigilance systems have evolved significantly. Initially,
these systems were reactive, focusing on post-marketing surveillance to detect and
manage ADRs. However, with advancements in technology and a better
understanding of drug safety, pharmacovigilance has become more proactive. Modern
systems now include risk management plans, signal detection, and proactive risk
minimization strategies

Key Milestones:
 1968: Establishment of the WHO Programme for International Drug Monitoring.
 1970s: Introduction of spontaneous reporting systems, where healthcare
professionals and patients report ADRs voluntarily.
 1980s: Development of regional pharmacovigilance programs, such as the
European Medicines Agency (EMA) in Europe and the Food and Drug
Administration (FDA) in the United States.
 2000s: Introduction of risk management plans and periodic safety update reports
(PSURs) to ensure continuous monitoring of drug safety.
 2010s: Expansion of pharmacovigilance programs to developing countries, with
initiatives like the Pharmacovigilance Program of India.

Conclusion:
The history and evolution of pharmacovigilance reflect the ongoing efforts to ensure
drug safety and protect public health. From its early beginnings to the sophisticated
systems of today, pharmacovigilance has become an essential component of the
healthcare system, continuously adapting to new challenges and advancements in
drug therapy.
1.3. Types of Pharmacovigilance:
a. Spontaneous Reporting System (SRS)
b. Active Surveillance
c. Targeted Spontaneous Reporting
d. Cohort Studies
e. Case-Control Studies
f. Pharmacovigilance Audits

1.3.A. Spontaneous Reporting System:

Spontaneous reporting is the most common type of pharmacovigilance. It involves
healthcare professionals, patients, and consumers voluntarily reporting adverse drug
reactions (ADRs) to regulatory authorities or pharmaceutical companies1. This
system relies on the vigilance of individuals to detect and report any unexpected or
harmful effects of medications.

Strength Weakness
 Real-World Data: The SRS  Underreporting: One of the major
provides valuable information from limitations of the SRS is the issue of
real-life clinical settings, which can underreporting. Many adverse events
be more representative of actual drug go unreported, which can lead to
use compared to controlled clinical incomplete data and delayed
trials. detection of safety issues.
 Wide Coverage: It can capture a  Bias: The system may be subject to
wide range of adverse events, reporting bias, where certain types of
including rare and long-term effects adverse events are more likely to be
that may not be detected in clinical reported than others.
trials.
 Lack of Detail: Reports may lack
 Early Detection: The system can sufficient detail to fully assess
help detect safety issues early in the causality and severity, making it
drug's lifecycle, allowing for timely challenging to draw definitive
regulatory action and risk mitigation. conclusions.

Key Features of Spontaneous Reporting System-

 Voluntary Reporting: Unlike active surveillance systems, the SRS depends on
individuals to report suspected ADRs without prompting from regulatory
authorities or pharmaceutical companies. This means that the system is only as
effective as the willingness of people to report incidents.
 Data Collection: Reports are collected from various sources, including
healthcare professionals, patients, and consumers. These reports typically include
information about the patient, the drug(s) involved, the adverse event, and any
other relevant details.
 Data Assessment: Each report is reviewed to assess the individual case and
identify any potential safety signals. This involves evaluating the causality
between the drug and the adverse event, as well as the severity and outcome of
the reaction.
 Data Interpretation: The collected data is analyzed to detect patterns or trends
that may indicate a new or emerging safety issue. This process helps generate
signals that can lead to further investigation and regulatory action if necessary.
 Signal Detection: One of the primary goals of the SRS is to detect signals, which
are essentially hypotheses about a potential causal relationship between a drug
and an adverse event. These signals are then investigated further to determine
their validity and significance.

Implementation and Examples:

Different countries have their own systems for spontaneous reporting. For example,
the Yellow Card Scheme in the UK has been in use since 1964 and encourages
healthcare professionals and patients to report suspected ADRs. Similarly, India's
Pharmacovigilance Programme promotes voluntary reporting of adverse reactions
through established monitoring centers.

1.3.B. Active Surveillance:

Active surveillance in pharmacovigilance is a proactive approach to monitoring the
safety of pharmaceutical products. Unlike spontaneous reporting, which relies on
voluntary reports from healthcare professionals and patients, active surveillance
involves systematic data collection and analysis to detect adverse drug reactions
(ADRs) and other safety issues.

Types of Active Surveillance:

1. Drug-Based Surveillance Identifying adverse events in patients taking specific

pharmaceutical products.
2. Setting-Based Surveillance Monitoring adverse events in particular healthcare
settings, such as hospitals or nursing homes.
3. Event-Based Surveillance Focusing on specific adverse events, such as acute
liver failure, that are likely to be associated with
medical products.

Key Features of Active Surveillance-

 Proactive Data Collection: Active surveillance involves actively seeking out
information on ADRs through various methods, such as monitoring specific
patient populations, healthcare settings, or clinical trials.
 Targeted Monitoring: This approach often focuses on specific drugs, patient
groups, or adverse events of particular interest. For example, monitoring patients
in emergency departments or those taking high-risk medications.
 Continuous Process: Active surveillance is an ongoing process that continuously
collects and analyzes data to identify potential safety signals early
 Use of Multiple Data Sources: Data for active surveillance can come from
electronic health records, registries, clinical trials, and other sources.
Advantages of Active Surveillance-
 Timely Detection: Active surveillance can detect safety issues more quickly than
spontaneous reporting because it involves continuous monitoring
 Comprehensive Data: By using multiple data sources, active surveillance can
provide a more complete picture of a drug's safety profile.
 Targeted Approach: Focusing on specific drugs or patient groups allows for
more precise identification of potential safety issues.

Challenges and Considerations-

Resource Intensive: Active surveillance requires significant resources, including
personnel, technology, and funding.
Data Quality: Ensuring the accuracy and completeness of the data collected is crucial
for effective analysis and signal detection.
Ethical Considerations: Protecting patient privacy and obtaining informed consent
are essential when collecting and using health data.

Examples of Active Surveillance Programs:

Sentinel Sites: Some countries use sentinel sites, such as selected hospitals or clinics,
to actively monitor drug safety.
Registries: Disease-specific registries can be used to track the safety of medications
used to treat those conditions.
Post-Marketing Studies: Conducting post-marketing studies to monitor the long-
term safety of newly approved drugs.

1.3.C. Targeted Spontaneous Reporting:

Targeted Spontaneous Reporting (TSR) is a specialized approach within
pharmacovigilance that focuses on collecting and analyzing reports of adverse drug
reactions (ADRs) for specific drugs, patient groups, or adverse events of particular
interest. This method aims to enhance the detection of safety issues related to
particular medications or patient populations.

Key Features of Targeted Spontaneous Reporting-

 Focused Scope: TSR targets specific drugs, patient groups, or adverse events,
allowing for a more concentrated and efficient monitoring process.
 Enhanced Detection: By focusing on particular areas, TSR can more effectively
detect rare or serious ADRs that might be missed in broader surveillance systems.
 Proactive Reporting: Healthcare professionals and patients are encouraged to
report ADRs related to the targeted drugs or events, increasing the likelihood of
capturing relevant safety data.
 Data Analysis: The collected data is analyzed to identify patterns or trends that
may indicate potential safety issues, leading to timely regulatory actions or risk
mitigation strategies.

Example:
FDA Adverse Event Reporting System (FAERS): The FDA uses targeted
spontaneous reporting to focus on specific drugs or adverse events, enhancing the
detection of safety signals and ensuring timely regulatory actions.
 BENEFITS CHALLENGES
 Improved Detection: Focusing on  Resource Intensive: Implementing
specific targets allows for more TSR requires dedicated resources,
efficient detection of rare or serious including personnel, technology, and
ADRs. funding.
 Enhanced Patient Safety: By  Reporting Bias: Encouraging
identifying and addressing potential reporting for specific targets may
safety issues, TSR contributes to the lead to reporting bias, where certain
overall safety of pharmaceutical types of ADRs are overrepresented.
products.
 Data Quality: Ensuring the accuracy
 Timely Regulatory Actions: Early and completeness of the data
detection of safety issues enables collected is crucial for effective
timely regulatory actions to protect analysis and signal detection.
patient safety.

1.3.D. Cohort studies:

These are a type of observational study commonly used in pharmacovigilance to
monitor the safety and effectiveness of drugs in real-world settings. These studies
follow a group of individuals (a cohort) over time to observe outcomes, such as
adverse drug reactions (ADRs) or other safety concerns.

Key Features of Cohort Studies-

 Purpose in Drug Safety: Cohort studies are particularly valuable for assessing
long-term safety and potential late-emerging effects of drugs. They provide real-
world evidence on how a drug performs in diverse populations, including those
with multiple comorbidities or taking various medications.

Advantage Disadvantage
 Representative Populations: They  Confounding Factors: There may
include a broader, more be confounding variables that affect
representative sample of patients the outcomes, making it challenging
compared to controlled clinical trials. to establish a direct causal
relationship.
 Multiple Outcomes: Cohort studies
can assess multiple outcomes and  Causal Relationships: Cohort
long-term effects studies cannot definitively establish
causality like randomized controlled
 Real-World Evidence: They provide
trials.
insights into how a drug performs in
everyday clinical practice, which  Resource Intensive: Conducting
might not be captured in clinical cohort studies requires significant
trials. resources, including time, personnel,
and funding.
1.3.E. Case Control Studies:
These are a type of observational study commonly used in pharmacovigilance to
investigate the association between an exposure (such as a drug) and an outcome
(such as an adverse drug reaction). These studies are particularly useful for studying
rare diseases or outcomes.

Key Features of Case-Control Studies-

 Retrospective Nature: Case-control studies are often retrospective, meaning they
look back in time to compare the exposure status of cases and controls.
 Matching: Cases and controls are often matched on certain characteristics (such
as age, gender, or other variables) to reduce the potential for confounding factors.
 Data Collection: Data on exposure and outcome are collected through medical
records, interviews, questionnaires, or other sources.

Advantage Disadvantage
 Efficiency: These studies are  Confounding: There is a risk of
relatively quick and inexpensive to confounding, where other factors
conduct, especially for rare may be associated with both the
outcomes. exposure and the outcome, leading to
biased results.
 Feasibility: They are feasible for
studying diseases or outcomes with  Recall Bias: Cases may remember
long latency periods. their exposures differently than
controls, leading to biased results.
 Hypothesis Generation: Case-
control studies are useful for  Causality: These studies cannot
generating hypotheses that can be establish causality; they can only
tested in future studies. suggest associations.

Example:
Cases: Patients who experienced severe bleeding while taking the anticoagulant.
Controls: Patients who took the anticoagulant but did not experience severe bleeding.
Comparison: The exposure to the anticoagulant and other potential risk factors are
compared between the two groups to determine if there is an association with severe
bleeding.

1.3.F. Pharmacovigilance Audits:

Pharmacovigilance audits are systematic and independent examinations of
pharmacovigilance activities to ensure compliance with regulatory requirements and
to identify areas for improvement. These audits are essential for maintaining the
integrity and effectiveness of pharmacovigilance systems.

Key Features of Pharmacovigilance Audits-

 Objective: The primary objective of pharmacovigilance audits is to assess the
quality and effectiveness of the pharmacovigilance system in detecting, assessing,
and managing adverse drug reactions (ADRs).
 Scope: Audits can cover various aspects of pharmacovigilance, including data
collection, signal detection, risk management, and communication of safety
information.
 Risk-Based Approach: Audits are often conducted using a risk-based approach,
focusing on areas with the highest potential impact on patient safety.
 Independence: Auditors must be independent and objective to ensure unbiased
assessments.

Steps in Conducting a Pharmacovigilance Audit:

 Planning: Define the scope and objectives of the audit, identify the audit team,
and develop an audit plan.
 Fieldwork: Conduct on-site visits, review documentation, interview staff, and
gather evidence to assess compliance with pharmacovigilance practices.
 Reporting: Compile findings, identify non-compliances and areas for
improvement, and prepare an audit report.
 Follow-Up: Implement corrective actions based on audit findings and monitor
their effectiveness.

Regulatory Guidelines:
The European Medicines Agency (EMA) provides guidelines on good
pharmacovigilance practices (GVP), including Module IV on pharmacovigilance
audits. These guidelines outline the structures, processes, and quality management
practices required for effective pharmacovigilance audits.

Advantage Disadvantage
 Enhanced Safety: Audits help  Resource Intensive: Conducting
identify and address potential safety thorough audits requires significant
issues, improving patient safety. resources, including time, personnel,
and funding.
 Regulatory Compliance: Ensures
that pharmacovigilance activities  Data Quality: Ensuring the accuracy
comply with regulatory and completeness of data collected
requirements. during audits is crucial for effective
assessments.
 Continuous Improvement: Provides
insights into areas for improvement,
fostering a culture of continuous
improvement in pharmacovigilance
practices.

Conclusion:
Pharmacovigilance audits are a critical component of ensuring the safety and efficacy
of pharmaceutical products. By systematically evaluating pharmacovigilance
activities, audits help maintain high standards of practice and protect patient health.
 UNIT 2
SOFTWARES USED IN
PHARMACOVIGILANCE
2.1. INTRODUCTION
Software solutions are essential in pharmacovigilance for several key reasons:
Efficiency: Automation of data entry, processing, and reporting tasks significantly
reduces the time and effort required to manage adverse event reports. This allows
pharmacovigilance teams to handle larger volumes of data more efficiently.
Accuracy: Automated systems help ensure the accuracy and consistency of data entry
and reporting. This reduces the risk of human errors that can occur with manual
processes.
Regulatory Compliance: Pharmacovigilance software is designed to comply with
global regulatory standards, such as E2B, FDA 21 CFR Part 11, and EMA guidelines.
This ensures that all safety data is managed and reported according to the latest
regulatory requirements.
Data Integration: These systems can integrate data from various sources, including
clinical trials, post-marketing surveillance, and literature, providing a comprehensive
view of drug safety.
Real-Time Monitoring: Software solutions enable real-time monitoring and analysis
of adverse event data, allowing for quicker detection of potential safety issues and
faster responses to regulatory requirement.
Cost-Effectiveness: By automating various pharmacovigilance processes, software
solutions can help reduce operational costs associated with manual data entry and
reporting.
Reporting and Analytics: These tools provide robust reporting and analytics
capabilities, allowing organizations to generate detailed safety reports, conduct trend
analysis, and make data-driven decisions.
Scalability: These systems can easily scale to accommodate increasing volumes of
safety data as organizations grow and new products are launched.

Some software’s used in pharmacovigilance are:

1. Oracle Argus Safety
2. ArisG
3. Oracle Adverse Event Reporting System (AERS)
4. PvNET
5. repClinical
6. PV works
7. VigiFlow
8. PharmaLex

We shall discuss some most commonly used software in Pharmacovigilance as we go

further in this post. Firstly let us discuss in detail about the Oracle Argus Safety
software, which is the de-facto standard for management of drug safety data used in
the industry today.
2.2. Oracle Argus Safety
Companies are increasingly shifting their focus to a more holistic view of product
safety beginning in clinical development and continuing through post-marketing
surveillance. Oracle Argus Safety is a comprehensive platform designed specifically
to address the life science industry’s complex pharmacovigilance requirements. Argus
Safety’s advanced database helps ensure global regulatory compliance, enables sound
safety decisions and integrates safety and risk management functions.

With Oracle Argus Safety companies can:

 Ensure global regulatory compliance
 Make faster, science based safety decisions
 Integrate safety and risk management
 Lower the cost of Pharmacovigilance

 Oracle Argus Safety – Ensures Global Regulatory compliance

Life science organizations must ensure that they are compliant with global regulations
and guidelines, including those of EMEA, FDA, ICH and a myriad of national
authorities. Extensive license partnerships, as well as outsourcing of some functions,
complicate the scenario and the industry is finding it increasingly challenging to
manage its world-wide reporting obligations. Companies depend on Argus Safety to
help manage their regulatory compliance requirements in a timely and proactive
manner.
Argus Safety supports reporting compliance via a comprehensive and robust reporting
engine that allows users to configure specific rules to match regulatory requirements.
When combined with advanced automation features such as “Auto/Force distribute”
and “Auto-Submit”, it enables full compliance and can lower the cost of regulatory
reporting.
 Oracle Argus Safety – Offers Better Data Insights and Faster decision making-
Argus safety has been developed with inputs from leading life science companies and
industry thought leaders with a focus on efficient and effective safety management.
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.
The system can be easily queries by end users without requiring SQL or support of IT
departments. Thus, safety data is readily accessible for timely review and reporting.
Other modules can also be fully integrated with Argus Safety, providing the ability to
readily reconcile SAEs from clinical trials or efficiently manage periodic reports.
 Oracle Argus Safety – Integrates Safety and Risk Management-
Pharmacovigilance departments are struggling with increasing case volumes,
disparate data sources and complex business partnerships, challenging their ability to
analyze and understand the safety data. The industry is struggling to maintain process
efficiencies while managing product risk profiles in real time.
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 – Key Features and Benefits:
i. Origination of cases via case entry screens
ii. Tracking of local data items
iii. Support for e-signatures
iv. Duplicate search capabilities
v. Local labelling decisions made against local data sheet or license
vi. Case views provided to appropriate local affiliate
vii. Ability for several affiliates to simultaneously view and make local labelling calls
against the same locked case
viii. Views of core documents and global protocols such as action items on a work list.
ix. Central staging area for reviewing submitted affiliate cases
x. Electronic submission capabilities
xi. Querying and reporting cases received and submitted
xii. 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
 Increase worker productivity by eliminating redundant data entryReduce risk by
allowing central safety group to accept or reject cases.

Fig.1 The Oracle Argus Analytics Architecture

2.3. ARISg
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. 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.

Key Features and Benefits of ARISg Software-

1. Case Management: ARISg offers robust case management capabilities, allowing
for efficient processing and management of adverse event reports.
2. Advanced Intake: The software streamlines the collection of safety data from
diverse sources using advanced automation, including AI and machine learning
technologies.
3. Literature Intake: ARISg automates literature management, helping to handle
and analyze safety-related literature efficiently.
4. Reporting & Analytics: It provides flexible and easy-to-use reporting and
analytics tools, offering real-time insights into case management.
5. Signal & Risk Management: ARISg includes automated signal detection and
risk management features to uncover higher-quality signals faster and inform
benefit-risk profiles.
6. Cloud-Based: The software is cloud-based, ensuring secure access to safety data
from anywhere, which is crucial for global operations.
7. Compliance: ARISg ensures compliance with all present and future regulatory
standards, making it easier for companies to adhere to safety regulations.

ARISg is trusted by over 300 companies worldwide for managing their critical drug
safety data. It helps reduce safety risks for drugs, devices, vaccines, and combination
products by improving case processing workflows and integrating with other systems
2.4. Oracle AERS
This is a comprehensive pharmacovigilance software solution designed to manage and
analyze adverse event reports for pharmaceuticals, biologics, vaccines, and medical
devices.
Biopharmaceuticals, vaccines, medical device companies and Contract Research
Organisations (CROs) are constantly challenged with meeting time-critical regulatory
requirements using limited resources. They must identify and mange safety events
before they become issues, and they need to maintain strict compliance with evolving
regulations. To manage critical business processes, they require clear visibility into
their data.

Some key features and benefits:

1. Case Management: Oracle AERS provides robust case management capabilities,
allowing for efficient processing and management of adverse event reports.
2. Regulatory Compliance: The software ensures compliance with global regulatory
requirements, including E2B (R3), E2B (R2), eVAERS, eMDR, MIR, and IDMP
standards
3. Automation: Built-in automation features reduce manual work by streamlining
intake, case prioritization, field validations, coding, narratives, and submission
processes.
4. .Advanced Analytics: Oracle AERS offers powerful analytics tools to uncover
insights from safety data, enabling faster and more informed decision-making.
5. Cloud-Based: The software is cloud-based, providing secure access to safety data
from anywhere, which is crucial for global operations.
6. Integration: Oracle AERS can be seamlessly integrated with other systems, such
as signal detection and risk management tools, to provide a comprehensive safety
solution.
7. Scalability: The software can handle rapidly increasing caseloads and adapt to
changing regulations, ensuring scalability for growing organizations.

 Oracle AERS provides a single global solution with powerful automation and
productivity tools to meet the challenges of managing your worldwide safety
information. Oracle AERS supports the capture, management, reporting and
analysis of serious adverse event and product compliance cases for all medical
products including drugs, medical devices, vaccines, biologics and gene therapies
from all clinical and spontaneous sources.

 Oracle AERS was designed by industry professionals to be easy to use for all
users. The intuitive interface provides powerful functionality at the touch of a
button. Each subsystem includes a navigator panel to provide overall context. The
AERS graphical user interface provides and interactive presentation of key case
information, allowing users to visualise the case elements and understand the
holistic case picture. Configuration and administration is performed through the
use of validated screens and simple end-user tools.
2.5. PvNET
PvNET is a a comprehensive pharmacovigilance solution and one of the leading
software used in pharmacovigilance with Adverse Event reporting, Adverse Drug
reaction (ADR) data management and regulatory reporting of ICSR (Individual Case
Safety Report) that goes beyond mere compliance. From early development through
post marketing, PvNET helps integrating the safety information, and thus helps users
to make critical decisions. PvNET is across the board drug safety successfully audited
against GMP standards, 21 CFR compliance and ICH E2B.

The extensive features of PvNET include:

i. Workflow which supports to segregate Data Entry, QC (Review) and scientific

assessment/medical review.
ii. Extensive data validation and cross-field validation checks – validate case files
for E2B compliance.
iii. Global Dictionary support and Dictionary management (MedDRA version
management)
iv. Audit records for safety data management activities
v. Management Dashboard: Delivers dashboard with the ability to focus on relevant
domain providing users with the information to draw attention to
jvcanomalies and outliers, making it possible for them to take actions quickly
vi. Serious Adverse event automated narrative writing & multi lingual text support
vii. Duplicate case checking
viii. Centralized triage prior to full case processing
ix. PvNET also has add on modules through which additional features can be added
to it.

Key features and benefits:

1. Adverse Event Reporting: PvNET provides a single platform for serious
adverse event (SAE) reporting, ensuring global regulatory compliance.
2. Regulatory Compliance: The software is compliant with E2B, US FDA 21 CFR
part 11 guidelines, and other regulatory standards, making it easier for companies
to adhere to safety regulations.
3. Integrated MedDRA Browser: PvNET includes an integrated MedDRA
browser for easy coding and terminology management.
4. Case Validation: The software features case validation based on in-built EMA
business rules, ensuring consistency and accuracy in reporting.
5. Workflow Stages: PvNET offers customizable workflow stages to streamline
case processing and management.
6. Auto Narrative Generation: The software generates consistent narratives for all
cases, improving efficiency and reducing manual work.
7. Global Database: PvNET serves as a global database that fulfills drug safety
requirements for multiple regions, including Europe, Canada, USA, and Australia
8. Signal Detection: The software supports quantitative and qualitative signal
detection, aiding in better risk-benefit profiling of drugs.
9. xEVMPD Solution: PvNET addresses regulatory requirements for xEVMPD,
ensuring clear identification of medicinal products across geographies.
10. Veterinary Reporting: The software also supports adverse event reporting for
veterinary medicinal products.
PvNET has been developed not only to record the adverse events but also analyze and
generate various regulatory reports, such as:
a. E2B compliant XMLs
b. CIOMS
c. MedWatch
d. ICH approved periodic reports including PSURs, bridging reports and other
annual reports.

Fig.2 PvNET Diagram

2.6. repClinical
repClinical is a secure web based service that helps you manage critical
pharmacovigilance activities in a timely an cost effective manner.

 With repClinical you can capture adverse event data, generate regulatory reports
and exchange ICSRs with multiple regulatory bodies and business partners. All
this in a simple intuitive and efficient way.

 repClinical provides clutter free screens and useful features to help generate
precise E2B reports easily.

 You can create, modify and track cases in repClinical. Cases can be assigned to
other users for updation or review. Case data corresponds to data contained in
section B of the ICSR as described in Electronic Transmission of Individual Case
Safety Reports Message Specification.

 In repClinical you can access case data – with a single click. This facilitates
quicker access of data without navigating through a menu. Also repClinical
performs a minimum data check for cases from early stages of data entry

 Creating messages in reClinical is fast and easy. The messages can be archived
for future download. Also the message is automatically validated. You can also
upload and maintain ICSR acknowledgement message along with the transmitted
message. repClinical also maintains an Audit trail for all the data added, modified
or deleted. You can view a chronological sequence of audit records detailing al
changes done to any data in a human readable format.

Key Features of repClinical

1. Adverse Event Reporting: repCLINICAL provides a robust platform for
reporting adverse events, ensuring compliance with global regulatory standards.
2. Case Management: The software offers advanced case management capabilities,
allowing for efficient processing and management of adverse event reports.
3. Regulatory Compliance: repCLINICAL ensures compliance with international
standards such as E2B, US FDA 21 CFR part 11, and other regulatory
requirements.
4. Integrated MedDRA Browser: The software includes an integrated MedDRA
browser for easy coding and terminology management.
5. Workflow Stages: repCLINICAL offers customizable workflow stages to
streamline case processing and management.
6. Auto Narrative Generation: The software generates consistent narratives for all
cases, improving efficiency and reducing manual work.
7. Signal Detection: repCLINICAL supports quantitative and qualitative signal
detection, aiding in better risk-benefit profiling of drugs.
8. Global Database: The software serves as a global database that fulfills drug
safety requirements for multiple regions, including Europe, Canada, USA, and
Australia.
9. Veterinary Reporting: repCLINICAL also supports adverse event reporting for
veterinary medicinal products.

Benefits:
a) Efficiency: repCLINICAL improves efficiency by automating various processes,
such as case intake, coding, and narrative generation.
b) Accuracy: The software ensures accuracy in reporting and case management
through built-in validation rules and standardized processes.
c) Compliance: repCLINICAL helps companies comply with global regulatory
standards, reducing the risk of non-compliance penalties.
d) Scalability: The software can handle rapidly increasing caseloads and adapt to
changing regulations, ensuring scalability for growing organizations.
e) Insights: repCLINICAL provides powerful analytics tools to uncover insights
from safety data, enabling faster and more informed decision-making.
f) Security: The software ensures secure access to safety data from anywhere,
which is crucial for global operations.

Use Cases:
 Pharmaceutical Companies: repCLINICAL is widely used by pharmaceutical
companies to manage and report adverse events for their products.
 Biotechnology Firms: Biotechnology firms use repCLINICAL to track and
manage adverse events related to their biologic products.
 Medical Device Manufacturers: The software is also used by medical device
manufacturers to ensure the safety and efficacy of their devices.
 Healthcare Organizations: Healthcare organizations use repCLINICAL to
report and manage adverse events for drugs and medical devices used in patient
care.

Conclusion
 repCLINICAL is a versatile and powerful pharmacovigilance software solution
that helps companies manage safety data efficiently and ensure compliance with
global regulatory standards. Its advanced features and benefits make it an
essential tool for any organization involved in drug safety and pharmacovigilance.
2.7. PV Works
PVWorks is a comprehensive software solution designed to support
pharmacovigilance (PV) activities in the pharmaceutical industry. Pharmacovigilance
is the science and activities related to the detection, assessment, understanding, and
prevention of adverse effects or any other drug-related problems.

PVWorks software is developed to facilitate the management of adverse event (AE)

reports, automate workflows, and ensure compliance with global regulatory
requirements.

Key features and functionalities of PVWorks:

1. Adverse Event Reporting and Management:
PVWorks allows users to collect, process, and manage adverse event reports from
various sources, including clinical trials, spontaneous reports, and literature reviews.
The software provides tools for data entry, coding, and narrative writing, ensuring that
all relevant information is captured and stored in a centralized database.

2. Workflow Automation and Case Management:

PVWorks features a configurable workflow engine that automates the processing of
adverse event reports, from initial receipt to final submission. The software assigns
tasks, sets deadlines, and sends notifications to ensure that cases are processed
efficiently and in compliance with regulatory requirements.

3. Regulatory Compliance and Reporting:

PVWorks is designed to support compliance with global regulatory requirements,
including those from the European Medicines Agency (EMA), the US Food and Drug
Administration (FDA), and the International Conference on Harmonisation (ICH).
The software generates reports in various formats, including CIOMS I, MedDRA, and
E2B.

4. Signal Detection and Risk Management:

PVWorks provides tools for signal detection and risk management, enabling users to
identify potential safety issues and take proactive measures to mitigate risks. The
software includes features for data mining, statistical analysis, and risk assessment.

5. Data Analytics and Visualization:

PVWorks offers advanced data analytics and visualization capabilities, allowing users
to gain insights into adverse event data and make informed decisions. The software
provides a range of reporting and visualization tools, including dashboards, charts,
and graphs.

6. Integration and Interoperability:

PVWorks can be integrated with other pharmacovigilance systems, such as safety
databases, clinical trial management systems, and regulatory information management
systems. The software supports various data exchange formats, including XML, CSV,
and JSON.
6. Security and Data Protection:
PVWorks is designed to ensure the security and integrity of adverse event data. The
software features robust access controls, data encryption, and auditing capabilities to
prevent unauthorized access or data breaches.

7. Training and Support:

PVWorks provides comprehensive training and support services to ensure that users
can effectively utilize the software. The software vendor offers online training
modules, user manuals, and dedicated customer support.

In summary, PVWorks is a comprehensive pharmacovigilance software solution that

supports the collection, processing, and management of adverse event reports. The
software automates workflows, ensures regulatory compliance, and provides
advanced data analytics and visualization capabilities. By leveraging PVWorks,
pharmaceutical companies can improve their pharmacovigilance operations, reduce
costs, and enhance patient safety.
2.8. Vigiflow
Vigiflow is a comprehensive pharmacovigilance software solution designed to
support the collection, processing, and management of adverse event reports and other
pharmacovigilance data. Developed by Extedo, a leading provider of
pharmacovigilance and regulatory solutions, Vigiflow is used by pharmaceutical
companies, contract research organizations (CROs), and regulatory authorities
worldwide.

Key Features of Vigiflow:

1. Adverse Event Reporting and Management: Vigiflow allows users to collect,
process, and manage adverse event reports from various sources, including clinical
trials, spontaneous reports, and literature reviews.
2. Workflow Automation and Case Management: Vigiflow features a configurable
workflow engine that automates the processing of adverse event reports, from initial
receipt to final submission.
3. Regulatory Compliance and Reporting: Vigiflow is designed to support
compliance with global regulatory requirements, including those from the European
Medicines Agency (EMA), the US Food and Drug Administration (FDA), and the
International Conference on Harmonisation (ICH).
4. Signal Detection and Risk Management: Vigiflow provides tools for signal
detection and risk management, enabling users to identify potential safety issues and
take proactive measures to mitigate risks.
5. Data Analytics and Visualization: Vigiflow offers advanced data analytics and
visualization capabilities, allowing users to gain insights into adverse event data and
make informed decisions.
6. Integration and Interoperability: Vigiflow can be integrated with other
pharmacovigilance systems, such as safety databases, clinical trial management
systems, and regulatory information management systems.
7. Security and Data Protection: Vigiflow is designed to ensure the security and
integrity of adverse event data, featuring robust access controls, data encryption, and
auditing capabilities.

Benefits of Using Vigiflow:

1. Improved Efficiency: Vigiflow automates many pharmacovigilance tasks,
reducing manual effort and increasing productivity.
2. Enhanced Compliance: Vigiflow ensures compliance with global regulatory
requirements, reducing the risk of non-compliance and associated penalties.
3. Better Decision-Making: Vigiflow provides advanced data analytics and
visualization capabilities, enabling users to gain insights into adverse event data and
make informed decisions.
4. Increased Transparency: Vigiflow provides a transparent and auditable record of
all pharmacovigilance activities, enabling users to demonstrate compliance and
accountability.
5. Reduced Costs: Vigiflow reduces the costs associated with pharmacovigilance,
including the costs of manual data entry, reporting, and compliance.

Implementation and Support:

Vigiflow is typically implemented on-premises or in the cloud, depending on the
user's preferences. Extedo provides comprehensive implementation and support
services, including:
1. Project Management: Extedo provides experienced project managers to oversee
the implementation of Vigiflow.
2. Training and Support: Extedo offers comprehensive training and support services,
including online training modules, user manuals, and dedicated customer support.
3. Customization and Configuration: Extedo provides customization and
configuration services to ensure that Vigiflow meets the user's specific needs and
requirements.

In summary, Vigiflow is a comprehensive pharmacovigilance software solution that

supports the collection, processing, and management of adverse event reports and
other pharmacovigilance data. With its advanced features and benefits, Vigiflow is an
ideal solution for pharmaceutical companies, CROs, and regulatory authorities
seeking to improve their pharmacovigilance operations and ensure compliance with
global regulatory requirements.
2.9. PharmaLex
Pharmalex is a comprehensive pharmacovigilance software solution designed to
support the collection, processing, and management of adverse event reports and other
pharmacovigilance data. Developed by PharSafer, a leading provider of
pharmacovigilance and regulatory solutions, Pharmalex is used by pharmaceutical
companies, contract research organizations (CROs), and regulatory authorities
worldwide.

Key Features of Pharmalex:

1. Adverse Event Reporting and Management: Pharmalex allows users to collect,
process, and manage adverse event reports from various sources, including clinical
trials, spontaneous reports, and literature reviews.
2. Workflow Automation and Case Management: Pharmalex features a
configurable workflow engine that automates the processing of adverse event reports,
from initial receipt to final submission.
3. Regulatory Compliance and Reporting: Pharmalex is designed to support
compliance with global regulatory requirements, including those from the European
Medicines Agency (EMA), the US Food and Drug Administration (FDA), and the
International Conference on Harmonisation (ICH).
4. Signal Detection and Risk Management: Pharmalex provides tools for signal
detection and risk management, enabling users to identify potential safety issues and
take proactive measures to mitigate risks.
5. Data Analytics and Visualization: Pharmalex offers advanced data analytics and
visualization capabilities, allowing users to gain insights into adverse event data and
make informed decisions.
6. Integration and Interoperability: Pharmalex can be integrated with other
pharmacovigilance systems, such as safety databases, clinical trial management
systems, and regulatory information management systems.
7. Security and Data Protection: Pharmalex is designed to ensure the security and
integrity of adverse event data, featuring robust access controls, data encryption, and
auditing capabilities.

Benefits of Using Pharmalex:

1. Improved Efficiency: Pharmalex automates many pharmacovigilance tasks,
reducing manual effort and increasing productivity.
2. Enhanced Compliance: Pharmalex ensures compliance with global regulatory
requirements, reducing the risk of non-compliance and associated penalties.
3. Better Decision-Making: Pharmalex provides advanced data analytics and
visualization capabilities, enabling users to gain insights into adverse event data and
make informed decisions.
4. Increased Transparency: Pharmalex provides a transparent and auditable record
of all pharmacovigilance activities, enabling users to demonstrate compliance and
accountability.
5. Reduced Costs: Pharmalex reduces the costs associated with pharmacovigilance,
including the costs of manual data entry, reporting, and compliance.

Implementation and Support:

Pharmalex is typically implemented on-premises or in the cloud, depending on the
user's preferences. PharSafer provides comprehensive implementation and support
services, including:
1. Project Management: PharSafer provides experienced project managers to
oversee the implementation of Pharmalex.
2. Training and Support: PharSafer offers comprehensive training and support
services, including online training modules, user manuals, and dedicated customer
support.
3. Customization and Configuration: PharSafer provides customization and
configuration services to ensure that Pharmalex meets the user's specific needs and
requirements.

In summary, Pharmalex is a comprehensive pharmacovigilance software solution that

supports the collection, processing, and management of adverse event reports and
other pharmacovigilance data. With its advanced features and benefits, Pharmalex is
an ideal solution for pharmaceutical companies, CROs, and regulatory authorities
seeking to improve their pharmacovigilance operations and ensure compliance with
global regulatory requirements.
 SUMMARY

Pharmacovigilance relies on various software solutions to manage and analyze

adverse event reports, ensuring the safety and efficacy of pharmaceutical products.
Here is a summary of some of the key software used in pharmacovigilance:

 Oracle Argus Safety: Comprehensive global regulatory compliance and risk

management solution.
 ARISg: Advanced case management and safety data processing tool.
 Oracle AERS: Adverse event reporting system ensuring regulatory compliance.
 PvNET: Robust adverse event reporting and regulatory compliance software.
 repCLINICAL: Versatile tool for managing adverse event reports across multiple
regions.
 PV WORKS: Software designed to support pharmacovigilance business
processes and regulatory compliance.
 PharmaVigilance: Integrated platform for managing pharmacovigilance activities.
 VigiFlow: Developed by WHO, this system supports the management of
individual case safety reports.
 Truven Health Analytics: Provides data analytics solutions for drug safety
management.
 PharmaLex: Offers regulatory compliance and pharmacovigilance services.
 ProVigilance: Comprehensive system for managing adverse event data.
 PharmaSugoi: Software for handling pharmacovigilance processes efficiently.
 IntegriTrial: Solution for integrating clinical trial data with pharmacovigilance
activities.
 MediData: Provides tools for adverse event tracking and reporting.
 PharmaScribe: Manages pharmacovigilance documentation and data.
 REFERENCES
1. Deye N, Vincent F, Michel P, Ehrmann S, da Silva D, Piagnerelli M, et al. Changes
in cardiac arrest patients’ temperature management after the 2013 TTM trial: Results
from an international survey. Ann Intensive Care 2016;6:4.

2. Meyboom RH, Egberts AC, Gribnau FW, Hekster YA. Pharmacovigilance in

perspective. Drug Saf 1999;21:429- 47.

3. UMC WHO [Internet]. Available from: https://www.who-umc org/about-us/who-

we-are/. [Last modified on 2018 Oct 1

4. Barr A, Feigenbaum E, Roads C. The Handbook of Artificial Intelligence, Volume

1. Comput Music J 1982;1:3-14

5. Mockute R, Desai S, Perera S, Assuncao B, Danysz K, Tetarenko N, et al. Artificial

Intelligence Within Pharmacovigilance: A Means to Identify Cognitive Services and
the Framework for Their Validation. Pharmaceut Med 2019;33:109-20

6. Chai, W. (2021, February). big data analytics. TechTarget. Retrieved September 13,
2021, from https://searchbusinessanalytics.techtarget.com/defi nition/big-data-
analytics.

7. Center for Drug Evaluation and Research. (2020, April 2). Postmarketing
surveillance programs. U.S. Food and Drug Administration. Retrieved October 3,
2021,from https://www.fda.gov/drugs/surveillance/postmarketing-surveillance-
programs.

8. Berniker, J. S. (n.d.). Spontaneous Reporting Systems: Achieving Less Spontaneity

and More Reporting. Why MedWatch is problematic. Retrieved October 4, 2021,
from https://dash.harvard.edu/bitstream/handle/1/8846816/Berniker.html
?sequence=2&isAllowed=y.