MedDRA
MedDRA provides standardized, global medical terminology for coding and reporting adverse events, facilitating consistent data collection, analysis, and regulatory compliance for pharmaceutical products. .....
Signal Detection
When a new drug is released, some side effects may only appear after widespread use. Signal detection helps find these hidden risks that clinical trials might miss.
It also tracks changes in known side effects, .....
Multisource Inbox
Adverse event (AE) reports come from multiple sources - healthcare professionals, patients, literature reviews, internal quality teams, and regulatory agencies. Managing all this data from different channels can be overwhelming,.....
Causality Matrix
Assessing the relationship between a drug and an adverse event is a critical part of pharmacovigilance. A structured approach is needed to determine whether a reported reaction is truly linked to the drug......
PubMed TDM
Pharmacovigilance relies heavily on processing scientific literature to identify potential safety issues. PubMed is a key database for this purpose, providing access to a vast collection of medical and scientific articles.....
Triaging
In pharmacovigilance, organizations often face challenges such as duplicate cases, missed deadlines, and high volumes of cases. This can lead to inefficiencies and delays in case processing, resulting in compliance risks and.....
Auto-Labeling
In pharmacovigilance, for every drug-event combination, different countries or regulatory agencies are required to check the appropriate label. Doing this manual takes a lot of time and can easily lead to mistakes, affecting the.....
TDM
In the domain of pharmacovigilance, handling and consuming vast amounts of literature is essential in pharmacovigilance. PvEdge's Literature Access Module (LAM) has proven invaluable in retrieving relevant articles......
SDEA
Nowadays, with the rapid development of new medications and the increasing complexity of healthcare systems, ensuring medication safety is more critical than ever. Traditional methods of monitoring safety often rely .......
PADER
Now-a-days Regulatory bodies like USFDA, EU strive to remain in competitive market, wants pharma companies to submit PADERs regularly to monitor the safety of marketed drugs as it mitigates risks and ensure patient safety.......