Clinical Evaluation Documents
We bring in-depth know-how to efficiently craft a fully-compliant Clinical Evaluation Report (CER)
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CER scoping & planning
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Gap analysis
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Benefit-risk analysis
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Demonstration of equivalence and/or similarity with similar devices​​
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Comprehensive and systematic state-of-the-art review
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PMCF & PMS documentation
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Literature review
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Ongoing updates and CER maintenance
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Integration with risk management processes
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Post-Market Clinical Follow-Up (PMCF)
We conduct effective & methodical PMCF activities adhering to latest regulatory standards
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PMCF strategy and plan
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Data source identification and collection
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Data analysis and interpretation
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PMCF Evaluation Report
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PMCF study protocols and reports
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PMCF ongoing monitoring and updates as needed
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Communicating PMCF findings to stakeholders including regulatory bodies
Post-Market Surveillance (PMS)
We provide comprehensive PMS activities fully compliant with country-specific regulations
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PMS strategy & execution - requirements from EU MDR, IVDR, ISO 13485-2016, 21 CFR, and guidance documents
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PMS plan & procedures
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PMS data compliance evaluation
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PMS report and Periodic Safety Update Report (PSUR) compilation and review
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PMCF requirements from PMS data
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Post-marketing literature surveillance
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Clinical Trial Management & Strategy
We offer turn-key clinical management services
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Clinical study design & protocol
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Site(s) selection & KOL/PI recruitment
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Project management & execution
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Monitoring visits on-site in Israel and globally (if required)
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Data collection & analysis
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Clinical study report
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Case Report Form CRF/e-CRF, Informed Consent Form (ICF)
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eTMF (Electonic Master File)
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Literature Reviews
We guide your clinical development with comprehensive research reports
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Research strategy, plan & scope
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Literature search, selection, data extraction & analysis
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Clinical writing & updates
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Systematic and narrative literature reviews
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New applications investigation
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New protocols investigation
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Medical guidelines review
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Scientific literature background for your new product or future research
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Data collection for regulatory purposes & CER submission
Clinical Publications
We craft high-quality clinical materials with effective messaging to amplify your impact in the scientific community
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Content writing and proofreading
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Data analysis & visual representation
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Journal identification, submission & peer review feedback
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Research articles
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Opinion pieces
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Narrative reviews
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Systematic reviews and meta-analysis
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Case reports and series
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Conference presentations & abstracts
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