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Drug Safety Triager

Our pharmacovigilance literature review software, created to help life sciences organizations meet their regulatory requirements

Streamlining literature screening workflows through automation, configurability and an intuitive user interface

Drug Safety Triager marks an evolution in drug safety literature monitoring, making the process more efficient, compliant and cost-effective.

Pharmacovigilance literature review software

Drug Safety Triager is our GxP-validated and audit-ready pharmacovigilance (PV) literature review software solution, created from the ground up to monitor literature for Individual Case Safety Reporting, Aggregate Reports and Signal detection. It makes the drug safety literature monitoring process more efficient, cost-effective and compliant. Our customers range from the top 10 global pharmaceutical companies to small biotech and Contract Research Organizations.

Intelligent automation

Using intelligent automation from our machine learning engine Dialog ® ML (part of the Dialog platform) and integration with upstream and downstream processes, Drug Safety Triager takes literature reviewing to a new level. It simplifies the process so that the review teams can focus on what matters most: patient safety.

GxP compliant

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.

Validation package

Each implementation of Drug Safety Triager is delivered with a validation package. The validation process and associated documentation align with the pharmaceutical industry and health authority regulations.

Audit trail

All literature references undergo a systematic review process that automatically captures all users’ actions and adds a permanent, non-editable audit trail to the record. This process ensures audit readiness for any organization using the Drug Safety Triager.

Benefits

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Configurable and easy to use

The automatic import and work allocation ensure that no reference is missed. The audit trail captures all user actions. A modern and intuitive user interface lets users concentrate on article analysis and safety assessment. The assessment outputs are delivered in compliant formats easily. Additionally, dashboards and reports provide oversight. The system is configurable to meet the workflow needs and the labelling desired by the customer.

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Workflows for global teams compliant with GVP regulations

The system is configurable to meet the workflow needs and the labelling desired by the customer. It provides timeliness tracking and quality control. The system assures Day zero visibility, including for changes related to full text, translation and author follow-up use and upload. The assessments’ output is compliant: ICSR are sent in E2B R3 to case processing, and Aggregate Reports are created in Vancouver style.

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Supported by artificial intelligence

Dialog Solution’s artificial intelligence engine DialogML is part of the Dialog platform. It uses Natural Language Processing to enhances Dialog alerts by automatically identifying references in scientific literature that meet the criteria for ICSR, Aggregate Reports or Safety Signals.

DialogML applies a patient safety relevancy ranking to each reference and adds drug safety tags. As a result, in the Drug Safety Triager the most relevant and time-sensitive references are presented at the front of the queue and have the drug safety relevant terms highlighted. With DialogML assistance, literature review teams can find ICSRs 5x faster and reduce the volume of literature to be reviewed for ICSRs by up to 50% without introducing additional risk.

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Increased efficiency with robotic process automation

Drug Safety Triager automatically imports references from Dialog and other literature providers. The system auto-deduplicates at import and consolidates references retrieved for multiple drugs. Additional manual deduplication allows users to reduce further articles needing review.

An automated workflow ensures references can be reviewed step-by step by multiple users for multiple purposes in an organised and transparent way. Automated work allocation and advancement of articles with step validation checks along the process enable all users to work independently and with full accountability.

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Full oversight and administrative control

Drug Safety Triager features a range of configurable dashboards that help increase oversight of even the largest drug safety monitoring workflows. The dashboard cards provide quick access to targeted statistics for an immediate view of work status, including potential risks, priorities and longer-term trends in the review workflow. Easy to use, configurable features allow the administrator role to be performed by either a business or an IT professional.

Administrator self-serve features include self-setup and configuration by the administrator, full control over account creation and user access, and admin changes during the trial. Ad-hoc importing of additional literature outside of scheduled alerts is also included.

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Efficiency and cost-savings

Drug Safety Triager is proven to deliver measurable efficiencies and cost savings through deduplication, multi-drug review, prioritization and reference review time reduction enabled by the AI assistant, bulk review, easily accessible SOP links and supporting documents, and an intuitive and streamlined interface. The best-practice workflow reduces irrelevant literature references to be reviewed for Aggregate Reporting and Signal detection by up to 70%.

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Instant access to full-text articles

Through the integration between Drug Safety Triager and two full text providers, the full text acquisition is streamlined. Literature reviewers can instantly access the full-text article needed for review, quickly upload it to the reference and update the day zero date, further increasing efficiency and reducing the chance of errors.

Get in touch

See how we can help your business.

With Drug Safety Triager you can:

70 %
reduce your Aggregate Report and Safety Signal review workload by 70%
50%
halve the volume of literature to be reviewed for ICSRs when using DialogML
5x
identify reportable adverse events 5x faster with assistance from our machine learning engine DialogML
100%
achieve complete compliance with literature monitoring and reporting regulations

Compared to what we had before, Drug Safety Triager is like going from a horse-drawn carriage to a space rocket

Head of Literature Screening Top 10 pharmaceutical company

We never before had drug safety software that worked from the first day with no errors and delivered the promised results

Manager Drug Safety Systems Top 50 pharmaceutical company

With Drug Safety Triager we just completed an EMA audit; we have zero findings from the literature review process

Director Global Information Services

We have never experienced a more competent, more flexible and more responsive vendor

Director Global Information Services

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Resources

Artificial Intelligence in Pharmacovigilance Artificial Intelligence in Pharmacovigilance
Case study
Artificial Intelligence in Pharmacovigilance

Using AI to help GSK detect ICSRs in scientific literature

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