Medical Literature Monitoring Detailed Overview

The industry-leading Medical Literature Monitoring solution for Drug Safety.  

Dialog pioneered the application of dedicated software solutions to streamline medical literature monitoring for ICSR, Aggregate Reports and Safety Signals and is the leader in this space. Our unique end-to-end suite of software, content and services is currently used by most of the Top 10 Pharmaceutical companies along with a wide range of other organisations including medium and smaller BioPharma, Generics, Biotechs, Medical Device companies and CROs. 

The Drug Safety Triager is central to our success and is proven to deliver measurable efficiencies and cost savings whilst increasing productivity, compliance and quality in a fully validated and audit-ready package. It is a workflow application that has been designed from the ground up to allow review teams to focus on patient safety issues in the scientific literature and streamline the literature monitoring processes for ICSR, Aggregate Reports and Safety Signals. The Drug Safety Triager provides complete management oversight, eliminates duplicated and inconsistent reference review and reduces the volume of literature that needs to be assessed by medics by 70-80%. After the review is complete, references containing patient safety issues are automatically output to case processing, medical writing and for signal evaluations. 

We are continually enhancing our applications with a roadmap of initiatives that includes the use of artificial intelligence and machine learning to increase efficiency by automating reference screening for patient safety issues. 

If you’d like to learn more, please contact us using the link below and we’ll be quickly back in touch. 

 The Drug Safety Triager is part of our dedicated end-to-end suite of content, software and services for Medical Literature Monitoring 

1 – Content 

Increase patient safety with truly comprehensive content coverage using standardised, deduplicated biomedical content required by the regulators including Medline, Embase, IPA, Biosis, Derwent Drug File conference databases and many more. With over 100 databases available, searches for signal evaluations are also supported. 

 Our content experts and engineers add 750,000 items to the system every day and standardise the myriad of formats produced by the database providers which enables seamless searching across multiple databases and eliminates the need for complex post processing of outputs. 

 

2 – Dialog Precision Search 

Dialog’s precision search is optimized for pharmacovigilance and is proven to minimize the volume of duplicated references delivered into the review process. Dialog outputs native XML enabling content to be integrated seamlessly into your Drug Safety Ecosystem. 

 Our trusted Dialog search specialists can help improve compliance by constructing audit-ready search strategies and assist in their ongoing maintenance as ontologies and the regulations change. 

 

3 – Dialog Alerts Manager 

The Dialog Alerts Manager makes the setup, maintenance and management of alerts an easy and time-efficient activity.    

 Pharmacovigilance searches can be scheduled run automatically on a day and time of your choosing and deliver the results directly to the Drug Safety Triager. To meet the expectations of regulators and inspectors, the Alerts Manager includes the following features:   

  • Download audit history for a precise record of changes including editor’s comments  
  • Create new alerts by copying an existing alert with one click  
  • Update search syntax in multiple alerts in one bulk action  
  • Edit strategy and other attributes easily on the same page  
  • Change delivery frequency or formats in multiple alerts in one bulk action  
  • Verify search strategy accuracy 
  • Review discrete, sortable lists for active, inactive and deleted alerts  
  • Easily re-activate deleted and inactive alerts  
  • Re-send alerts to original or different recipients 

 

4 – Drug Safety Triager 

Fully Validated and configurable workflow tool that drives compliance, quality and productivity. The Drug Safety Triager can be configured and scaled to suit all sizes of organisations to streamline the literature monitoring processes for ICSR, Aggregate Reports and Safety Signals. 

 

The Drug Safety Triager has a roadmap of enhancements to keep you at the forefront of medical literature monitoring including the use of artificial intelligence and machine learning to speed up the review. increase efficiency by automating reference screening for patient safety issues. 

 

5 – Literature Review 

We have a long-established Literature Monitoring team who can help customers with critical, time consuming, and resource-intensive tasks within the drug safety workflow. Our process assures the customers receive all reportable ICSRs within the time-frame they require and reduces the volume of literature that has to be reviewed by customer product leads/safety scientists for Aggregate Reports and Safety signals by 70-80%. 

 Based in the USA and UK, each member has English as their mother tongue, many are multilingual and all have considerable experience of Literature Monitoring for safety, relevant qualifications and experience. Quality is central to our Literature Monitoring activities and this is facilitated by a low turnover of staff enabling team members to work on the same project and gain invaluable experience of the nuances associated with each client’s product portfolio. 

 

6 – Output 

After the references have been reviewed, those containing patient safety issues can be automatically output to seamlessly integrate with your existing Drug Safety Ecosystem. 

 For example, the Drug Safety Triager can transform references into E2BR3 for case processing, output tightly defined bibliographies in Vancouver Style for medical/regulatory writing and pre-defined formats for signal evaluations. 

 For management oversight, automated reports typically include Review Performance statistics, KPIs and Quality of review. 

 If you’d like to learn more, please contact us here and we’ll be quickly back in touch.