We make Pharmacovigilance Literature Monitoring for Product Safety simple, efficient, and compliant
Overcome the challenge of monitoring growing amounts of literature for your product safety. On one hand, you have a mandate to keep up with the expansion of published literature for your product safety and, on the other hand, to manage your organization’s cost in this process. Whether your organization reviews scientific literature for Individual Case Safety Reporting, Aggregate Reporting or Signal Detection, we streamline your workflow and make it audit and inspection ready. With our end-to-end solution you can maintain accurate, up-to-date, and complete drug safety information for your marketed products in one organized place.
Get in touch with us today to discuss how we can improve your approach to pharmacovigilance literature surveillance or take a look at the resources below.
Distill the world’s scientific literature to just the essential articles about your products’ safety
Dialog Solutions Product and Services help you with
- Scientific Literature monitoring for your drug safety (Dialog platform)
- Product safety alerts and searches (Dialog Alerts Manager)
- Literature review workflow tool for ICSR, Aggregate Reports and Signal Detection (Drug Safety Triager)
- Providing Pharmacovigilance experts to perform the literature review.
Drug Safety Triager, a validated automated SaaS workflow tool, seamlessly organizes your literature assessment process and integrates it with your other downstream and upstream pharmacovigilance activities. With dashboards, automated workflow, and our artificial intelligence engine, DialogML, our platform transforms your process from tedious to easy and from hard to manage into effortless to oversee.
This database hosts all literature that you care about for your drug safety, with all the history of decisions you took to include or exclude from reporting to health agencies.
End-to-End pharmacovigilance literature monitoring solution workflow
High-efficiency literature monitoring helps you save time, so you can focus on Patient Safety
- Simplify the submission of Individual Case Safety Reports from literature to your Case processing department, creation of Aggregate Reports such as PSUR, PBRER, DSUR, and creation of Potential Signals line listings
- Comply with health agencies regulations, FDA, EMA, PMGA
- Get GxP validation documentation from us, your testing effort is kept to a minimum, keeping you audit & inspection ready
- Enjoy the productivity you can gain due to deduplication, automated best-practice workflow and reporting capabilities, powered by DialogML
- Configure, oversee, and control your workflow process and teams roles with ease
- Integrate with upstream and downstream pharmacovigilance activities
Explore specific use cases
Drug Safety Triager
Our GxP validated fully automated literature monitoring solution
Pharmacovigilance Literature Monitoring
Streamlined drug safety reporting solution
Medical Device Literature Reviews
Comprehensive solution for EU MDR clinical evaluation reports
Drug Development Intelligence
Drug development intelligence at your fingertips
Read how we have helped large pharmaceuticals with automation of pharmacovigilance literature monitoring
How does Dialog Solutions help us with Deduplication?
Dialog Solutions provides auto-deduplication and Drug Safety Triager provides an additional manual deduplication option. Depending on the content provider, data could be not normalised, so an additional deduplication algorithm can be applied within the literature monitoring software. This way, potential duplicates are brought to the attention of the reviewer, who then decides whether or not the reference is a duplicate and needs to be assessed.
How can Artificial Intelligence help me in Pharmacovigilance literature monitoring?
Dialog Solutions AI-driven solution then gives each article it has looked at a relevancy ranking score and lists them based on this score. This means the abstracts most likely to contain an ICSR are at the top of the list and those least likely are at the bottom. This allows ICSR reviewers to focus their time and effort on the articles that are most relevant, helping them more quickly find relevant ICSRs and eliminate the non-relevant ones.
How can Dialog Solutions help me with automation of literature monitoring?
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.
Can Dialog Solutions provide me with a fully validated literature monitoring solution?
Dialog Solutions Quality Management System provides the framework to consistently deliver products and services that meet customer and regulatory requirements. We are ISO 9001:2015 certified within the scope of Medical Literature Monitoring Solutions. Each implementation of Drug Safety Triager is delivered with a validation package. The validation process and associated documentation are in line with pharmaceutical industry and health authority regulations.
All literature references undergo a systematic review process which automatically captures all users’ actions and adds a permanent, non-editable audit trail to the record. This process ensures audit readiness for any organisation using Drug Safety Triager.
Speak to our team
Learn how Dialog Solutions can help you with Pharmacovigilance Literature Monitoring.