The development of clinical literature reports, essential for clinical evaluation, regulatory submissions and post-market surveillance, is a time-consuming and labor-intensive process. It requires meticulous review of vast amounts of data and carries a high risk of error or omission, which can impact a device’s time to market or continued approval.
AlvaMed uses assistive AI tools to help generate literature reports faster, allowing for significantly reduced turn-around time for final results. All reports are reviewed and finalized by experienced clinical and regulatory professionals, ensuring compliance and quality at every step. Unlike generative AI tools, this tool is purpose-built for medical device related article analysis and data extraction, and maintains full data integrity through secure, proprietary architecture with no use of third-party AI.
We begin by securely reviewing your clinical literature and applicable source documents. Then perform an initial analysis and data extraction, identifying key information relevant to your regulatory requirements.
We efficiently extract and organize data points, including study details, patient demographics, and clinical outcomes, into a structured tabular format. We use our proprietary tools designed to accelerate the initial review and data organization phase of clinical reporting.
Our team of experienced clinical writers and regulatory professionals conduct a thorough review, analysis, and interpretation of the data, ensuring accuracy, compliance, and clinical context.
Our experts draft, format, and finalize the summary clinical literature report, delivering a document that is ready for internal review or direct regulatory submission.
A clinical literature review is a systematic process of searching, appraising, and analyzing published scientific data on a medical device or a similar “equivalent” device. It is a mandatory part of the Clinical Evaluation Report (CER), which is a key document for demonstrating the safety and performance of a medical device to regulatory bodies like those in the EU (under MDR) or the FDA. Clinical literature reports can also be additive for other submissions needing supportive clinical evidence or used to justify post-market surveillance activities.
No. Our AI platform does not write or generate the final report. The tool and its tabular output is used to assist our experts by efficiently processing and extracting data from source documents. The final report is written, reviewed, and approved by our experienced clinical writers and regulatory professionals.
No, relying solely on internal data is generally not sufficient. Regulatory bodies, particularly under the EU MDR, require a comprehensive and systematic search and review of published clinical literature. This is necessary to establish the “state of the art”—the current standard of care and technology for your device category—and to demonstrate that your device’s safety and performance are in line with or better than what’s currently available.
Our experts employ a process that starts with a clearly defined literature search protocol. Our experts draft a literature search protocol that outlines the search strategy, including the specific databases queried (e.g., PubMed, Embase, Cochrane), keywords, and inclusion/exclusion criteria. A systematic and reproducible approach is critical. All identified articles, including those that are ultimately excluded, must be documented with a clear justification for their exclusion. This detailed documentation is often a key point of audit scrutiny by Notified Bodies.
Kerry has more than 15 years of experience managing and supporting clinical research, regulatory affairs and quality assurance projects. She is certified by the Society of Clinical Research Associates (SoCRA) as a Clinical Research Professional (CCRP® ).
Schedule a meeting with Kerry Beckett to discuss how AlvaMed can make your clinical literature review process more efficient.
