Pharmacovigilance

With growing government and public concern over drug safety, pharmacovigilance (PV) has never been more important. To ensure patient safety, minimize costs and ease regulatory compliance, pharmaceutical firms must aggressively detect and manage emerging safety risks. Yet early risk detection can be undercut by manual processes and a lack of integration across information sources.

Pharmacovigilance

Today's zero-tolerance drug safety environment requires pharma firms to adopt new strategies to quickly identify health safety concerns. You also need more progressive thinking and business-IT models to address evolving issues such as:

  • New compliance requirements for risk management
  • Pressure to cut drug discovery costs
  • Maintaining uniformity and consistency across global PV processes
  • Integrating safety data from disparate sources

At Cognizant, we provide robust, scalable and optimally engineered PV solutions that position you for long-term success.

Services and expertise

To help you reduce regulatory and business risks and achieve new levels of business performance, Cognizant’s offerings leverage our vast experience in drug safety process consulting, IT solutions implementation and PV process outsourcing. With deep domain understanding and detailed process knowledge, our consultants can provide the following services:

  • PV strategy and roadmap
  • PV maturity and gap analysis
  • Product evaluation and vendor selection
  • Business case analysis
  • PV IT Reference Architecture

In concert with industry leaders Oracle, Phase Forward, Medidata and Relsys, we also provide integrated solutions that span PV and clinical solution delivery and training. Our PV consultants can help you find the most appropriate commercial off-the-shelf (COTS) and custom solutions across the entire drug safety value chain and PV lifecycle. Their expertise includes:

  • Implementation of PV COTS products
  • Signal detection applications
  • Business Intelligence solutions
  • Enterprise portals for safety analytics
  • Analytics, querying and reporting
  • Validation and regulatory compliance
  • Data migration

Proven frameworks

We deliver accelerated services via proven frameworks that include:

  • MORE—a tool that assesses PV process offshoring
  • ASPIRE—for safety analytics, signal detection and analysis
  • CARES—a process transition model that employs our global delivery model to tap the best and most cost-effective resources worldwide

Outsourcing solutions

Cognizant provides business and knowledge process outsourcing of key PV functions, which can help you focus on more strategic functions. Our expertise includes:

  • Voice-based call center
  • End-to-end AE case processing—case intake and triage, medical coding and narrative writing
  • Medical reviews
  • PSUR writing and aggregate reporting
  • Pharmacoepidemiologic assessment

Flexible approach

Powered by a global team of experts, we offer a flexible engagement model that saves time and money. We can help you transform your business with tangible innovation and transformational outcomes that are both measurable and tightly aligned with your strategic requirements.

Plus, we are actively involved in top industry forums such as the Clinical Data Interchange Standards Consortium (CDISC) and the Drug Information Association (DIA), which means you stay current with evolving industry standards. Work with us to optimize your PV processes, and keep your business growing and healthy.