Small biotech and pharmaceutical companies in clinical development must effectively monitor and assess scientific literature to understand and address safety risks in their compounds, ensuring successful regulatory submissions.
The scientific literature is crucial for detecting possible risks that affect the benefit-risk profile of a medicine, as recognized by regulators worldwide. Failure to perform literature monitoring per regulatory guidance, or delaying it, can lead to missed safety information, submission failures, inspection failures, and approval delays, causing significant re-work.
To identify new risks and adverse events promptly, the FDA requires pharmaceutical and biotech companies to monitor scientific literature for new safety information related to their products from clinical development through post-marketing.
FDA Requirements for Literature Monitoring
For drugs and biological products under clinical development, the FDA's industry guidance, detailed in "Sponsor Responsibilities - Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies," states that sponsor-investigators must evaluate all available safety information, including data from scientific literature reports.
The guidance mandates that "reports in the scientific literature, including unpublished reports of which the sponsor becomes aware," must be systematically reviewed by sponsors.
Post-marketing, the FDA's document "Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines" requires timely reporting of serious, unexpected adverse experiences from scientific literature as 15-day reports.
Successful Literature Monitoring Processes
A regulated literature monitoring process requires careful implementation, as per FDA's regulatory guidance:
1. Search Literature Sources Globally: The FDA mandates that events from the literature should be sourced globally, including serious and unexpected adverse experiences from all sources.
2. Consider Broad Search Terms: Sponsors must ensure that reports of serious, unexpected adverse experiences for products with the same active moiety as those marketed in the US are submitted, even if other factors vary.
3. Establish a Repeatable Process with Clear Roles and Responsibilities: Compliance requires a documented, repeatable process with clear roles, responsibilities, and oversight. Literature searches and assessments must be conducted consistently and timely, with all decisions documented and traceable.
4. Start Early: Early detection and addressing of adverse events and potential risks improve the chances of successful regulatory submissions and demonstrate robust safety monitoring as products progress from clinical development to post-marketing.
FDA-Compliant Literature Monitoring with Crypta
Ensuring compliant literature monitoring and capturing important safety data is challenging due to the growing volume of published articles and the significant "paperwork" burden on safety teams. Manual literature monitoring methods are resource-intensive and risk missing critical safety events.
Crypta offers a complete platform for conducting regulated literature monitoring activities effectively and in full compliance. Designed specifically for safety teams, it helps streamline the monitoring process.
Easy to Use SaaS + Fully Configurable Workflows = Productive Teams
With an intuitive web-enabled interface, product configuration and assessments are easily managed within a fully auditable environment. The flexible workflow, tailored for safety monitoring teams, supports any literature screening process. Unique AI-powered automation features ensure efficient workflows for busy teams, achieving up to 70% efficiency gains compared to manual processes.
Compliance as Standard
The Crypta Platform is a fully validated and compliant solution, designed to meet stringent CFR-11 traceability and security requirements. It includes extensive audit-ready features such as activity logging, reporting, and fine-grained access controls, ensuring complete compliance and security.
To learn more, get in touch and book a demo today.
Your insightful and thorough exploration of this crucial aspect of clinical research is truly commendable. The depth of information you provide, coupled with clear, actionable guidance, makes navigating the complexities of FDA compliance far more approachable. It's evident that a great deal of expertise and dedication goes into each post. Your blog is an invaluable resource for professionals in the field, and I look forward to each new article with great anticipation. Keep up the excellent work!