Strategic Report: Adverse Event Reporting and Pharmacovigilance from Piribo.com

Summary

Life Science Insights believes that pharmacovigilance risk management will be one of the fastest-growing application areas in the drug development arena in 2005, with an estimated CAGR of 812% from 2004 to 2008. Driven by growing interest among regulators, consumers, and the medical community, drug safety is rising in both importance and visibility to drug manufacturers. The ability to predict and thereby prevent catastrophic drug safety failures is the goal of all adverse event reporting and pharmacovigilance risk management activities.

According to analyst Judy Hanover, "Pharmacovigilance technology is still in the formative stages, but it has the potential to prevent future catastrophic drug safety failures."

Content

Life Science Insights Opinion

In This Study

Situation Overview

Adverse Events
Regulatory Compliance

Premarketing

Postmarketing

Adverse Events in Clinical Trials
Postmarketing Adverse Event Reporting
Data Mining
Signal Detection
Drug Safety Data
Governance Issues
Mandatory Postmarketing Risk Management
Voluntary Pharmacovigilance

Future Outlook

The Pharmacovigilance Continuum
Figure: The Pharmacovigilance Continuum
Emerging Drug Safety Technology
Table: Functionality Expertise of Vendors at a Glance

Adverse Event Reporting

Reconciliation of Adverse Events with Clinical Data

E2B Electronic Submission of Adverse Events

Safety Database

FDA AERS Data

Data Mining with FDA AERS Data

Signal Detection

Signal Monitoring and Management

Pharmacovigilance

Essential Guidance

Pharmacovigilance Process
Corporate Governance
Selecting an Adverse Event Reporting and Pharmacovigilance Vendor
Figure: Vendor Solutions on the Pharmacovigilance Continuum
Adverse Event Reporting and Pharmacovigilance Vendors

Selected Vendor Profiles

Vendor Profiles

ArisGlobal

Table: ArisGlobal at a Glance

Galt

Table: Galt at a Glance

Insightful

Table: Insightful at a Glance

Lincoln Technologies

Table: Lincoln Technologies at a Glance

Oracle

Table: Oracle at a Glance

Phase Forward

Table: Phase Forward at a Glance

Relsys

Table: Relsys at a Glance

SAIC

Table: SAIC at a Glance

SAS

Table: SAS at a Glance

Learn More

Acronym and Abbreviation Glossary
Synopsis

Regulation & Policy

Adverse Event Reporting and Pharmacovigilance

Making Drug Safety Happen

Price £2,500.00