High-recall, high-precision capture of adverse drug reactions

Making the best drug risk–benefit decisions requires comprehensive information. A systemic approach to pharmacovigilance considers signals from multiple sources of information – including peer-reviewed literature, spontaneous adverse event reports and other regulatory documents.

Pharmacovigilance - PharmaPendium | Elsevier

How PharmaPendium helps

Designed to support critical decisions in pre- and post-market drug safety workflows, PharmaPendium provides comparative regulatory-based evidence in a single database. It offers:

  • Comprehensive access to searchable regulatory documents from the FDA and EMA
  • Dedicated search functions for the FDA Adverse Event Reporting System (FAERS), including tools to reveal differences in adverse event reporting
  • Extracted comparative data on safety, pharmacokinetics, efficacy, and metabolizing enzymes and transporters.

PharmaPendium ensures that users can:

  • Find post-market safety data to augment PV reporting requirements
  • Identify safety signals and drug–drug interaction risks in a timely manner
  • Reveal potential DDI risk in with pairs of concomitant drugs and substances
  • Build more effective evidence-based risk management strategies
  • Anticipate potential safety risks in clinical studies and post-market
  • Perform all searches in alignment with ICH’s MedDRA terminology

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Early predictions about potential DDIs

Predicting potential adverse interactions between candidate compounds and marketed drugs is critical in ensuring safety in clinical trials and beyond. PharmaPendium’s new DMPK Solution leverages excerpted PK and ME&T data, FDA and EMA documents, and literature along with a powerful DDI Risk Calculator to reveal drug safety early in development.

Customer story

Reducing adverse event risk with informed, data-driven decisions about DDIs - PharmaPendium | Elsevier

The key to avoiding DDIs

Today, drug-drug interactions (DDIs) account for 3-5% of all reported adverse drug reactions. Find out how to best identify potential DDIs and assess their risk.

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How PharmaPendium supports drug safety

PharmaPendium offers dedicated functionality and data modules that provide insight into drug safety, including drug–drug interactions and spontaneously reported adverse events from the FDA Adverse Event Reporting System.

Download the PharmaPendium fact sheet (PDF, 0.604 MB)

Efficacy Module

Optimize drug candidate selection and mitigate the risk of sub-optimal clinical trial study designs with deeply enriched, comparative efficacy data extracted from FDA and EMA drug approval documents.

Download the efficacy fact sheet (PDF, 2.3 MB)

DMPK Solution

Identify and assess potential drug-drug interactions (DDI) with a powerful DDI Risk Calculator along a unique source of extracted, easily searchable pharmacokinetic (PK) and metabolizing enzyme and transporter (MET) data.

Download the DMPK fact sheet (PDF, 0.693 MB)

Ideas and insights for industry professionals

Making the most of spontaneous reporting data

Making the most of spontaneous reporting data - R&D Solutions | Elsevier

Detecting signals from spontaneous reporting data is critical as they represent an unrestricted view of the adverse events landscape. However, this data is cluttered by heterogeneity and biases. See how to make the most of the data you need.

Read the white paper

Improving the accuracy of signal detection

Signal detection in spontaneous reporting can be challenging - R&D Solutions | Elsevier

Pharmacovigilance ensures the correct use of a drug, safeguarding it as a meaningful treatment option. But working with spontaneous adverse event reporting systems poses challenges. Find out how to overcome them.

See the white paper

Learn more about Elsevier's R&D Solutions for Pharmacovigilance

Achieve pharmacovigilance with less pain with solutions that help you identify critical patient safety signals and automate the processes of capturing and managing adverse drug reaction and safety information, 
Learn more about Pharmacovigilance solutions