Medical literature is an important source of information for suspected adverse reaction case reports of
authorized medicines. Medical Literature Monitoring is a regulatory requirement for the Manufacturing
Authorization Holders (MAH).
Marketing authorization holders of medicines are responsible for monitoring the medical literature for their
medicinal products and reporting individual cases of suspected adverse reactions to global regulatory
authorities such as EMA and national authorities.
The MAHs typically face various challenges with the literature monitoring process, people, and systems.
Namely, some of these are:
- Significant volume of medical literature articles and abstracts across various global and local literature journals and databases
- Volumes are growing annually
- Duplicity of information and versions of the same articles across databases
- Management of an effective, trackable, auditable search strategy for the product portfolio
- Format and language barriers
- Standardization of process for search, prioritization, and filtering of relevant information
- Resource and workload management
- Assurance of data quality
- Resources’ expertise, training & learning
- Costs
- Extraction of relevant adverse event information from full-text literature articles
Some of these challenges cannot be addressed by technology:
- Resources’ expertise
- Local market expertise
- Multi-disciplinary collaboration
- Continuous learning
What NOESIS brings to the table
Drogevate NOESIS can help with addressing the following:
- Can process any volume – NOESIS is scalable to cater to increasing volumes
- NOESIS can identify duplicates and versions of the same articles across databases
- NOESIS allows effective configuration, and management of an effective, trackable, auditable search strategy for the product portfolio
- NOESIS can process information in any format and in any language
- NOESIS provides for standardization of the process for literature search, prioritization, and filtering of relevant information. NOESIS allows human reviewers to review and update system decisions
- Resource and workload management
- Consistent data quality
- Costs management
- Extraction of relevant adverse event information from full-text literature articles and creation of a standard output such as E2B (R3) or JSON
Ease of use is a central aspect of the NOESIS platform, providing a simplistic user interface that aligns
with the expectations of business users in terms of usability and process support. The users can navigate
and utilize the NOESIS platform effectively, minimizing the learning curve and maximizing productivity.
Why should you automate Literature Monitoring?
There are various drivers for considering automating the literature monitoring process with a technology
solution.
- Higher accuracy and data quality
- Increased process standardization
- Higher compliance
- Increased operational efficiency
- Reduction in resources and costs
- On-demand scalability to cater to increasing volumes
- Easier to manage regulatory inspections
What are the risks of automation?
Automation is not without risks, and these should be carefully evaluated and mitigated while selecting an
automation platform.
- People – change resistance, lack of transparency, overreliance on technology
- Business Process – how to avoid the sales hype, defining and agreeing to the “to-be” state, system support for incorporating human decisions, reviews, and control
- Artificial Intelligence – what is the approach taken by the solution to implement AI, accuracy of the AI models, AI training, testing and benchmarking approach, monitoring & improvement approach and cycles, avoidance of bias
- Validation – time to validate, AI training datasets and approach, verification of the AI’s decision- making process, consistency & reproducibility, monitoring
- Regulatory acceptance – data security, privacy, ethics, data quality, transparency, testing, audits, monitoring
What should your automation solution do?
A literature monitoring automation platform should be selected based on it meeting some key automation
objectives and KPIs.
- It should be able to access multiple third-party literature databases
- It should be scalable to handle any volume of data
- It should provide automation benefits such as reduced manual efforts, increased quality and efficiency, reduced costs, meet compliance
- Provide efficiency gains across all process workflow steps based on a pre-defined realistic benchmark such as an efficiency gain of ~50% when compared to manual processes
- For data extraction, it should provide an F1 score of ~0.75+
- It should be able to support regulatory inspection by managing historical logs of searches, manual decisions, reviews, corrections, etc.
- It should be able to generate an E2B R3 or similar structured output from the full-text literature article
- It should integrate seamlessly with upstream and downstream systems
Your system should do more…
Your automation platform should automate the complete end-to-end case management process and not
just the literature monitoring part. The system should support the automation of case intake from various
structured or unstructured sources such as structured forms, images, unstructured text, excel/CSV
listings, and literature full-text articles. The system should provide very high data extraction accuracy to
reduce manual quality reviews. The system should automate various manual tasks like redaction of
personally identifiable information (PII) and protected health information (PHI), initial/follow-up/duplicate
identification, language translation, coding, data entry, follow-up queries, narrative generation, and
merging of information from multiple documents, etc. The system should employ data privacy and security
mechanisms like encryption, role-based access, redaction/masking, audit logging, etc.
In conclusion, selecting the right automation solution for literature monitoring can be very difficult given
the amount of vague and misleading information floating around. A thorough evaluation of the
organization’s automation objectives and a risk assessment must be conducted before selecting a
solution. A recommended approach is to conduct a pilot with a few shortlisted solutions to create a
scorecard for each solution and perform an objective assessment.
Ready to experience the benefits of automation in literature monitoring? Explore NOESIS, the leading case
management automation SaaS platform. Automate your literature monitoring process and enjoy the efficiency,
accuracy, and cost savings it brings to your organization. Request for a demo, followed by a pilot with your data to
learn more and start streamlining your literature monitoring process today.
