Digitalize and Automate Literature Screening while increasing efficiency and achieving compliance
According to GVP Module VI, every Marketing Authorization Holder (MAH) should have a dedicated Literature Monitoring program as part of safety monitoring of medicinal products to regularly search for articles in the literature databases and report adverse events. Non-compliance to this requirement may result in challenges like missing relevant ICSRs, inadequate aggregate reporting, missing safety signals and a major audit finding leading to withdrawal of the drug from the market.
Common Challenges faced by MAH Representatives
- Literature searches are labor intensive and consume a lot of time to go through large volumes of scientific articles
- Lack of connected search capabilities from different biomedical literature databases
- Performing literature screening is tedious with the rapid volume increase in of scientific literature
- Manual processes that are error prone leading to quality and compliance issues
- Poor visibility on ongoing partner and vendor engagements with no provision to track SLA timelines and compliance adherence
- Lack insights on non-compliance issues that could result as findings during audits and inspections
Introducing Compier Literature Screening
Compier Literature Screening is an AI-driven powerful platform that allows PV Professionals to screen Abstracts, Full Texts and Translated articles to identify patients, authors, events, products and safety related information and categorize each literature article as per its relevancy. It facilitates the complete lifecycle of Literature monitoring from initial review to ICSR intake in a Safety System.
Solution Features & Benefits
Import Literature Articles
Compier has built-in integration with online biomedical databases such as Medline, etc. and the provision to bulk upload literature records such as Embase articles, conference presentations, PDF Journals, etc..
Automatic Duplicate Check
For every literature search, Compier performs automated duplicate check against records obtained from the integrated literature databases and auto-classified as a duplicate record for futher action.
Perform Automated Literature Screening
Using validated AI-models, Compier performs automatic screening and annotation of entitities such as patients, products and events.
Define Lifecycle Management Workflows
Configure scalable literature screening business workflows specific to your requirements, SOPs, and global regulations.
Request Full Texts and Perform Online Translations
Communicate with third party vendors or integrate with third party tools for obtaining Full Texts and leverage built-in Translation capabilities for different articles.
Integration with Safety System
Transmit ICSR relevant articles to a safety system with all relevant data points and abstract, full text and translated articles as attachments. Compier has an out-of-the box integration connectivity with Oracle Argus Safety.
Correspondence and Collaboration
Leverage the built-in Compier correspondence functionality to request and receive literature full-text articles from different providers.
Process Alerts & Notifications
Proactively track all submission timelines and stay informed on the progress of literature screening schedules through configurable system alerts and notifications.
Gain Actionable Insights on Literature Screening
Users can filter and generate operational tracking reports related to literature monitoring outcomes such as article volumes screened, processed and transmitted for downstream safety related actions.
Value Proposition
Business Benefits
> Use AI to screen Abstracts, Full Texts and Translated articles to categorize the literature article and identify patients, authors, events, products and safety related information.
> Perform user reviews on identified information to accept, reject or add additional data points and submit articles for secondary reviews
> Digitally track the complete Lifecycle of Literature monitoring from initial review to ICSR intake in a Safety System
> The established integration of Compier with literature databases such as Medline, Embase, etc. eliminates manual search complexities and reduces overall resource effort
> Perform the complete literature monitoring and screening process with a 21 CFR Part 11 compliant audit trail that tracks all activities.
> Generate reports to get insights on literature screening outcomes and ongoing PV operations
Solution FAQs
We offer the Compier Literature Screening solution using the Software as a Service (SaaS) model with a standard Service Level Agreement (SLA). Additionally, Techsol shall also provide professional services to complete the successful implementation, configuration, validation, and global rollout of the Compier Literature Screening system along with the required system integrations.
Compier Literature Screening is a GxP regulatory compliant software system that fulfills FDA’s 21 CFR Part 11 and EU Annex 11 requirements. Techsol will provide the complete IQ/OQ validation documentation during the time of system implementation.
Our subject matter experts will deliver a hands-on Compier Literature Screening application training to your application champions by using ‘Train-the-trainer’ approach. Trainings will be delivered primarily through web conference using standard presentations.
The Compier Literature Screening solution architecture is designed to support various types of system integrations to eliminate manual effort and facilitate stakeholder collaboration across different PV business functions for increasing quality, compliance, and productivity.
The system supports a wide range of external system integrations using RESTFUL APIs and file-based data exchange transactions. Our approach towards integrations with third party solutions is based on industry standards, web services, APIs, and open architecture-based solutions.
Compier PV Ops Modules
End-to-End Pharmacovigilance Solutions
Latest Relevant Case Studies
December 29, 2022
Establishing an Integrated Global Drug Safety and Signal Management Cloud Solution
December 29, 2022
Argus Safety Cloud Implementation and Validation on Oracle Cloud for HUGEL Pharma
December 29, 2022
Serious Adverse Event (SAE) Management, Review and Reporting to DCGI during the COVID 19 Pandemic for an Ophthalmology Clinical Study
Latest Relevant Insights
August 30, 2021
Literature Screening – Process overview, challenges en-route and the scope for automation
