Infosys (Pharmacovigilance)

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https://www.infosys.com
Infosys
Type Public
Industry Information Technology and Services
Founded 1981
Headquarters Bangalore, Karnataka
Number of employees 10,001+


History

Established in 1981, Infosys is an NYSE listed global consulting and IT services company with more than 200,000 employees. From a capital of US$ 250, we have grown to become a US$ 10.2 billion (FY17 revenues) company with a market capitalization of approximately US$ 36.3 billion. In our journey of over 35 years, we have catalyzed some of the major changes that have led to India's emergence as the global destination for software services talent. We pioneered the Global Delivery Model and became the first IT company from India to be listed on NASDAQ. Our employee stock options program created some of India's first salaried millionaires.[1]

Clinical and pharmacovigilance outsourcing Client requirements in clinical research outsourcing vary from small projects to end-to-end studies – as large pharmaceuticals and mid-tier life sciences companies warrant the same attention and quality commitment from service providers.

Infosys-Ecron Acunova (EA) partnership realizes that small projects and low budgets refer to high stakes in clinical research. Our unique delivery model ensures project success through flexible and scalable solutions. Whether the need is medical/scientific expertise for protocol design, implementation of a clinical data management system, or adverse event call centres, we have the solutions.

Pharmaceutical and biotech companies are under increased scrutiny by the regulatory agencies to address their drug safety issues as well as re-evaluate their systems and processes for timely reporting while maintaining regulatory compliance.

A comprehensive technology solution is needed to address the challenges in the pharmacovigilance space. Infosys offers a comprehensive suite of pharmacovigilance solutions under a single umbrella of Safety Data Management solutions targeting drug safety issues.[1]

Infosys-Ecron Acunova (EA) partnership realizes that small projects and low budgets refer to high stakes in clinical research. Our unique delivery model ensures project success through flexible and scalable solutions. Whether the need is medical/scientific expertise for protocol design, implementation of a clinical data management system, or adverse event call centres, we have the solutions.

Pharmaceutical and biotech companies are under increased scrutiny by the regulatory agencies to address their drug safety issues as well as re-evaluate their systems and processes for timely reporting while maintaining regulatory compliance.

Our end-to-end service offering comprises regulatory consulting, IP import and sample export, protocol design, ethics committee submissions, safety screening, and bio-analytical testing. In addition, we are experts in clinical study management, method development and validation, data management with Oracle Clinical, PK analysis using WinNonlin, statistical analysis using an SAS, and report writing.

Our partnership blends the focus and specialization of a boutique CRO with the resources of a large services firm. We provide domain knowledge, patient access, technology services, and financial strength to pharma and biotech companies. With Infosys and EA, clients no longer have to compromise on quality for speed. Our team of medical and regulatory professionals accelerates time-to-market in compliance with Food and Drug Administration (FDA), European Medicines Agency, and other international regulations.

Features

  • The solution offers a Web-hosted safety data exchange application combining two different safety databases between partner companies for efficient exchange of safety information on jointly marketed products.
  • Provides a customized Web component, building an interface between safety and clinical databases for an online reconciliation of SAEs.
  • Offers a document-control solution for electronic capture of all source and submission documents related to drug safety.
  • Enables efficient reporting of safety information to regulatory authorities in the form of a global submission tool.
  • Enables early detection of ad hoc and hazardous signals.

[2]

Benefits

  • Based on multi-tier Web-enabled architecture for higher scalability and maintainability
  • Customer-specific alignment with clients’ existing technology and infrastructure
  • Robustness to support company-specific business changes
  • Enables compliance with 21 CFR part 11, GCP, and worldwide regulations on safety data management
  • Provides very high standards of data integrity and security

Overview

Infosys offers a comprehensive suite of pharmacovigilance solutions under a single umbrella of Safety Data Management solutions targeting drug safety issues.

Robust customer specific compliance enabling scalable Pharmacovigilance solution

Features

  • The solution offers a Web-hosted safety data exchange application combining two different safety databases between partner companies. This promotes efficient exchange of safety information on jointly marketed products.
  • Provides a customized web component, building an interface between safety and clinical databases, for online reconciliation of SAEs.
  • Offers a document-control solution for electronic capture of all source and submission documents related to drug safety.
  • Enables efficient reporting of safety information to regulatory authorities in the form of a global submission tool.

Benefits:

  • Based on multi-tier web-enabled architecture for higher scalability and maintainability
  • Customer-specific alignment with clients’ existing technology and infrastructure
  • Robustness to support company-specific business changes

[3]

Services

  • AiKiDō
  • Consulting Services
  • Business Services
  • Technology Services
  • Outsourcing Services

[4]

Top 5 Recent Tweets

DateAuthorComment
July 07, 2020InfosysInfosys brings into play its #designthinking driven #automationtesting solution for a Global Pharma major's… https://t.co/8YAMgJLriH


Top 5 Recent News Headlines

Top 5 Lifetime Tweets

Top 5 Lifetime News Headlines

  1. https://www.infosys.com/about/Pages/history.aspx
  2. https://www.infosys.com/industries/life-sciences/industry-offerings/Pages/safety-data-management.aspx
  3. https://www.infosys.com/industries/life-sciences/industry-offerings/Pages/safety-data-management.aspx
  4. https://www.infosys.com/industries/life-sciences/industry-offerings/Pages/safety-data-management.aspx

Verification history