Pharmacovigilance Service Provider | PV Transformation: AI-led PV operations, Case Processing Services, & Analytics | Aggregate Reporting | Drug Safety Reporting System

AI Led Pharmacovigilance Transformation in Life Sciences

A significant uptick in the number of drugs receiving approvals, combined with increased media and patient scrutiny, is sharpening the focus on Drug Safety.

To lead in this scenario, Life Sciences companies need to recaliberate to meet the surging volumes of data, evolving regulations, increasingly discerning patients and difficulties in Adverse Drug Reaction (ADR) reporting.

A significant uptick in the number of drugs receiving approvals, combined with
increased media and patient scrutiny, is sharpening the focus on Drug Safety.

To lead in this scenario, Life Sciences companies need to recaliberate to meet the
surging volumes of data, evolving regulations, increasingly discerning patients and
difficulties in Adverse Drug Reaction (ADR) reporting.

WNS enables organizations to outperform with a suite of proprietary platforms and tools tailored to address requirements across the end-to-end pharmacovigilance space. We utilize 20-year-plus Life Sciences experience and market-leading expertise in data, analytics and automation to drive agility, efficiency, customer-centricity and compliance in pharmacovigilance.

>40% Efficiency Improvement
~30% Digital Containment
~30% Increase in Customer Adoption Rate
>20% Improvement in Patient/Reporter Experience

Fit-for-Purpose Proprietary Solutions in Pharmacovigilance
delivering Tangible Outcomes and significant cost benefits

Smart, advanced offerings to digitally transform Life Sciences operations and build patient engagement

Augment Pharmacovigilance with Human and Digital
Proficiency or Comprehensive Services for Elevated Efficiency

Delivering excellence by leveraging industry expertise and advanced technologies across the entire spectrum of
pharmacovigilance operations

Case Receipt

Multilingual contact center
Medical information
Literature search
Social media data scraping
Affiliate case intake

ICSR Case Processing

Book-in, data entry
Triage
QC review
Medical review
Reconciliations
Submissions/distribution/follow-up

Report Writing

PBRER
PADER
PSURs
DSURs
Safety narrative writing

Safety and Risk Management Epidemiology

Signal detection
Label updates
Epidemiology (qualitative and quantitative)
Risk Management Plan and Risk Evaluation and Mitigation Strategy writing

Safety Database Services

Safety database setup and maintenance
L1 helpdesk

Specialized Pharmacovigilance Services

Qualified Person Responsible for
Pharmacovigilance (QPPV) services
Qualified Person Responsible for Pharmacovigilance (QPPV) services
Clinical adjudication committee

Case Study

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Success Stories

Client: US-based Pharma Company

Objectives:Set up an efficient and automated method to report data for adverse events, product complaints and clinical queries

Solution

Zero-Code form designer and publisher, ability to add custom and out-of-the-box validations, code-list uploads, form reusability, quick migration to higher environments, integration with multiple systems, customized branding and themes and efficient reconciliation

Outcomes

90% of time saved for development and amendment to existing forms
Low implementation cost
Out-of-the box validated forms
Unified workflows and monitoring
Non-compliance reports
Centralized tracking
No maintenance overheads

Client: US-based Contract Research Organization

Objectives:Fetch data insights and trends to make decisions, prevent compliance defaults and assess operational performance. In addition, the company needed to reduce the total cost of ownership, quickly retrieve data from multiple sources and provide secure data access to their clients

Solution

Implemented WNSAnalytics, enabling end users to create their own line listings, summary tabulations, and charts, and provided development area for advanced reporting for power users. Smart connectors were provided to plug in different data sources

Outcomes

Scalable system to support high case volumes of 10+million initial cases
Lower total cost of ownership
Accelerated turnaround of ad-hoc requests
Provision of access to clients to their own data rather than granting access to the Safety System

Client: Top 10 Global Contract Research Organization

Objectives:To support the company’s Risk Evaluation and Mitigation Strategy (REMS), optimize costs and ensure a smooth and efficient transition of work.

Solution

Provided resources for the required support and to ensure medical records are submitted to the US FDA within prescribed timelines, on-time training support, proactive risk assessment and mitigation and proprietary automation tools

Outcomes

Helped the client meet US FDA timelines
Ensured US strategic audit requirements are fulfilled

Client: Global Pharma Company

Objectives:To address challenges in signal management such as capturing adverse events well, minimizing the number of false positives, recognizing hidden signals and managing detection across different tools and methods.

Solution

WNS, through Appian, developed a tool integrating multiple signal detection sources, master data for product names and therapeutic areas and signal detection sources.

Outcomes

A collaborative, cross-functional, centralized BPM solution
Efficient and standardized signal management activities
Easier access to information for decision-makers, stakeholders and regulatory inspectors
Documentation of signal detection, assessment, decision-making and risk minimizing actions
Generation of system alerts of assigned tasks, actions and decisions in real-time

Why Choose WNS?

20+ years of Healthcare and Life Sciences excellence, along with strong credentials in pharmacovigilance and analytics
A scalable model with a qualified talent pool to work across
Pharma and Healthcare practices
Strategic partnerships with our clients to co-create a transformational journey in all areas of business improvement
An in-depth understanding of pharmacovigilance frameworks and patient support services
Best practices from other industry verticals to drive digital and domain expertise
Embedded technology and an innovation-led program transformation approach

Pharmacovigilance

AI Led Pharmacovigilance Transformation in Life Sciences

Fit-for-Purpose Proprietary Solutions in Pharmacovigilance
delivering Tangible Outcomes and significant cost benefits