Our pharmacovigilance (PV) literature monitoring solution offers a modular, end-to-end approach to literature surveillance for pharmacovigilance.
It gives any organization tasked with drug safety reporting a streamlined, efficient and compliant approach to the entire literature triage process.
Pharmaceutical companies of all sizes, contract research organisations, medical device manufacturers, biotech and biopharma firms use our drug safety literature screening solution to identify and review articles for Individual Case Safety Reporting, Aggregate Reporting (including PBRER, PSUR and DSUR) and Safety Signals detection.
Our modular, end-to-end approach to drug safety reporting means we can improve every element of this process:
We provide access to all essential content databases for pharmacovigilance through the Dialog® platform.
Databases available through Dialog include Embase, MEDLINE, International Pharmaceutical Abstracts, Allied and Complementary Medicine and BIOSIS.
The Dialog platform delivers a consistent search experience across multiple databases, ensuring all relevant drug safety results are identified. With precision search, deduplication and quality XML output, Dialog is the industry standard for searching medical literature.
Our Literature Search Services team can also create custom, regulatory compliant drug safety search strategies for your medical literature monitoring workflow.
The Dialog Alerts Manager simplifies the process of automating and managing multiple drug safety searches in Dialog. It also provides a range of features to meet the expectations of regulators and inspectors, such as audit trail of search strategy set up and changes and alert delivery history.
DialogML is part of Dialog and uses artificial intelligence to make the literature review process quicker, more efficient and more thorough.
DialogML enhances Dialog alerts by identifying references in scientific literature that meet the criteria for ICSR, Aggregate Reports or Safety Signals and applying a patient safety relevancy ranking to each reference and specific drug safety tags. This means the most relevant and important references are presented to reviewers at the front of the queue helping them better prioritise their workload, find relevant articles more quickly, and speed up analysis and review.
Literature articles retrieved by the Dialog Alerts Manager are integrated directly into Drug Safety TriagerTM, our next-generation GxP validated and audit-ready pharmacovigilance literature monitoring solution. It makes the drug safety literature monitoring process more efficient, cost-effective and compliant. The system streamlines the literature monitoring workflow by eliminating duplicated content, reducing the volume of literature to be reviewed and automatically outputting literature references relevant for patient safety issues.
In addition, Drug Safety Triager adds artificial intelligence assistance to the literature review process without introducing additional risk. It also gathers evidence for continuous algorithm improvement, paving the way for future phases of automated submission of the most relevant articles and elimination of the most irrelevant articles.
Our literature monitoring team helps our customers with critical, time-consuming and resource-intensive tasks within the drug safety monitoring workflow.
Comprehensive literature coverage
We provide access to over 140 content databases, including MEDLINE, Embase and Biosis. We also standardize all our medical literature database content to provide a consistent search experience, eliminating the need for complex post processing.
The DialogML relevancy ranking engine is part of the Dialog system and uses Artificial Intelligence to apply a patient safety relevancy ranking to each reference in your Dialog search alerts results.
The relevancy ranking score, together with highlighting of key safety concepts, help make the literature monitoring process more efficient and reduces literature reviewers’ workloads without introducing additional risk.
Drug Safety Triager, our validated pharmacovigilance literature triage solution, delivers measurable efficiency and cost savings, while increasing productivity and compliance. The automated workflow ensures all articles are methodically ingested, processed and outputted for drug safety issues.
Advanced alert management
The search and alerts manager built into our pharmacovigilance monitoring solution makes it easier to manage and schedule multiple drug safety searches.
Through our search platform Dialog, we offer precision search in our medical literature databases. Search results are output into a native XML format so they can be integrated seamlessly into drug safety reporting ecosystems.
Our medical literature monitoring solution is fully validated and compliant with the reporting requirements of global safety bodies, including the FDA, EMA and PMDA.
Shorten drug alert set up and management time by 80%
Reduce the Aggregate Report and Safety Signal review workload by 70%
Identify reportable adverse events 5x faster with assistance from our machine learning engine DialogML
Halve the volume of literature to be reviewed for ICSRs when using DialogML
Achieve complete compliance with literature monitoring and reporting regulations