Pharmacovigilance (PV) Literature Monitoring

Our pharmacovigilance (PV) literature monitoring solution offers a modular, end-to-end approach to literature surveillance for pharmacovigilance. It gives any organisation tasked with drug safety reporting a streamlined, efficient and compliant approach to the entire literature triage process.

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.

At every stage of the medical literature monitoring process, we help our customers save time and money. Using our pharmacovigilance literature monitoring solution, our customers are able to:

%

Shorten drug alert set up and management time by 80%

%

Reduce the Aggregate Report and Safety Signal review workload by 70%

5x

Identify reportable adverse events 5x faster with assistance from our machine learning engine DELVE

%

Halve the volume of literature to be reviewed for ICSRs when using DELVE

%

Achieve complete compliance with literature monitoring and reporting regulations

Pharmacovigilance (PV) Literature Monitoring with Dialog Solutions

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:

Comprehensive Scientific and Medical Literature

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.

Dialog®

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.

Dialog® Alerts Manager

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.

DELVE

DELVESM

DELVE is part of Dialog and uses artificial intelligence to make the literature review process quicker, more efficient and more thorough.

DELVE 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.

Drug Safety Triager

Literature articles retrieved by the Dialog Alerts Manager are integrated directly into Drug Safety Triager, 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.

Literature Screening Services

Our literature monitoring team helps our customers with critical, time-consuming and resource-intensive tasks within the drug safety monitoring workflow.

Dialog Solutions Pharmacovigilance (PV) Literature Monitoring Features and Benefits:

Comprehensive literature coverage

We provide access to over 140 content databases, including MEDLINE, Embase and Biosis. We also standardise all our medical literature database content to provide a consistent search experience, eliminating the need for complex post processing.

INTELLIGENT AUTOMATION

The Dialog DELVESM 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.

Improved Efficiency

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.

Alert Creation

Advanced ALERTS management

The search and alerts manager built into our pharmacovigilance monitoring solution makes it easier to manage and schedule multiple drug safety searches.

PRECISION SEARCH

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.

Validated and compliant

Our medical literature monitoring solution is fully validated and compliant with the reporting requirements of global safety bodies, including the FDA, EMA and PMDA. 

Streamline Your Medical Literature Monitoring: Free Resources

Pharmacovigilance (PV) Literature Screening: Best Practice Checklist

Click the button below to download our exclusive, 18-step best practice guide for optimising your drug safety literature screening process. 

Medical literature monitoring case study: Taking an end-to-end approach

"The Dialog Drug Safety Triager has enabled us to save time, introduce multiple efficiencies and switch outsource partners with no disruption. I would highly recommend it.”   The Brief We were approached by a top ten pharmaceutical organisation to streamline its global medical literature monitoring for drug safety. Tired of managing multiple systems and sources, it wanted to move forward with...

Can AI and machine learning automate medical literature monitoring?

If you work in pharmacovigilance (PV), are the robots coming for your job? Medical literature monitoring is part of the PV process with significant scope for automation. On the face of it, this seems an obvious insight. Literature monitoring ticks all the boxes for needing to be automated. It can be repetitive, time-consuming work that ties up experts who could be spending more time on patient...

You Need to Reduce Duplicate References in Your Medical Literature Monitoring: Here’s Why

Too much information. In our everyday lives it’s an irritation, at worst. But in medical literature monitoring, it’s a major issue. How do you cut through the noise to find the reference that really matters? In our paper Better Relevance, we discussed how precision search can cut down the volume of alerts relevant to adverse events by 30-50%. But this alone doesn’t solve the information overload...

Doing It Right: The Rigorous Approach to Medical Literature Monitoring for Drug Safety

Correctly identifying adverse events from medical literature is one of the key tasks in pharmacovigilance (PV). It’s also one of the most complex. The sheer volume of information available is overwhelming: so much so that even in the most precisely constructed searches, only five percent of references retrieved will be relevant. Then there’s the issue of duplicate articles, which on average,...

How to Reduce Missed Drug Safety References with Precision Search

Can a single missed drug safety reference be a billion dollar problem? If it’s been missed in literature monitoring for pharmacovigilance, it can. A missed drug safety reference can have serious consequences, with PV professionals making the wrong conclusions and patients being harmed, prompting lawsuits, regulatory action and precipitous share price falls. But when marketing authorisation...

Why Quality Management and Validation Matter for Medical Literature Monitoring

“It is not enough to do your best; you must know what to do, and then do your best”. So said W. Edwards Deming, quality guru and founder of the concept of continuous improvement that transformed Japanese industry after World War II. With this maxim, Deming captured the essence of Quality* management and validation in the medical literature monitoring (MLM) software that is used in...

How our end-to-end pharmacovigilance literature monitoring works [VIDEO]

At Dialog Solutions, we work with some of the world’s biggest pharmaceutical companies to deliver modular, end-to-end medical literature monitoring for pharmacovigilance. What’s more, we’re the only organisation that offers a truly end-to-end approach to drug safety literature monitoring. We provide the content (including the top biopharma collections), software (Dialog with Alerts Management...

[VIDEO] How to deploy resources effectively in pharmacovigilance literature monitoring

When it comes to identifying patient safety issues relating to drugs, scientific and medical literature is a crucial resource. Get pharmacovigilance literature monitoring wrong, and you could draw the wrong conclusions about patient safety issues – or delay making decisions – in a way that could lead to patients being harmed. The challenge is knowing how to deploy literature monitoring resources...

Dialog Alerts: Delivering Relevant Pharmacovigilance Literature Alerts for Drug Safety Aggregate Reports

Dialog alerts are a central part of our pharmacovigilance literature monitoring solution. They ensure key medical literature is automatically searched on a regular, predictable basis to deliver relevant journal articles for drug safety monitoring. An important part of this is the creation of aggregate reports, used by pharmaceutical and medical device companies for product authorization and...

On-Demand Webinar: Manage growing literature review workloads with pharmacovigilance automation and integration

Literature review teams in drug safety departments are overloaded with a rising tide of work and decreasing budgets. The number of adverse events being reported is growing year on year, along with the amount of literature that needs to be monitored. For drug safety teams, this pace isn't sustainable; they either need to employ more reviewers or run the risk of valid ICSRs being missed by...

On-Demand Webinar: Manage growing literature review workloads with pharmacovigilance automation and integration

Literature review teams in drug safety departments are overloaded with a rising tide of work and decreasing budgets. The number of adverse events being reported is growing year on year, along with the amount of literature that needs to be monitored. For drug safety teams, this pace isn’t sustainable; they either need to employ more reviewers or run the risk of valid ICSRs being missed by overworked teams.

In our on-demand webinar we take a closer look at these issues and what drug safety teams can do to address them. By watching our on-demand webinar you’ll learn more about:

  • The unavoidable challenge pharmaceuticals face from a growing literature review workload
  • Why this workload is unsustainable
  • What pharmacovigilance automation can do to streamline the literature review workload without adding risk
  • How integration with downstream systems can improve the whole pharmacovigilance workflow
  • How drug safety departments can prepare for the future of literature monitoring for product safety

Enter your details to watch the webinar:

Video Series: End-to-end literature monitoring in pharmacovigilance with Dialog Solutions

Take a look at these three short videos to see exactly how our end-to-end solution for medical literature monitoring works in practice. Between the three videos, you’ll get a better understanding of:

 

Get In Touch

We can help with all elements of medical literature monitoring for pharmacovigilance, saving you time and money as well as improving regulatory compliance and reducing the risk of missing patient safety alerts. Contact us using the button below to see how we can support you.