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Clinical Evaluation Documents
Post Market Surveillance
Post-Market Clinical

Clinical Evaluation Documents

We bring in-depth know-how to efficiently craft a fully-compliant Clinical Evaluation Report (CER)

  • CER scoping & planning 

  • Gap analysis

  • Benefit-risk analysis

  • Demonstration of equivalence and/or similarity with similar devices​​

  • Comprehensive and systematic state-of-the-art review

  • PMCF & PMS documentation

  • Literature review 

  • Ongoing updates and CER maintenance  

  • 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

  • PMCF strategy and plan

  • Data source identification and collection 

  • Data analysis and interpretation 

  • PMCF Evaluation Report 

  • PMCF study protocols and reports

  • PMCF ongoing monitoring and updates as needed

  • Communicating PMCF findings to stakeholders including regulatory bodies

Post-Market Surveillance (PMS)

We provide comprehensive PMS activities fully compliant with country-specific regulations

  • PMS strategy & execution - requirements from EU MDR, IVDR, ISO 13485-2016, 21 CFR, and guidance documents 

  • PMS plan & procedures

  • PMS data compliance evaluation

  • PMS report and Periodic Safety Update Report (PSUR) compilation and review

  • PMCF requirements from PMS data

  • Post-marketing literature surveillance

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Clinical Publications
Clinical Trial Services
Literature Reviews 

Clinical Trial Management & Strategy

We offer turn-key clinical management services

  • Clinical study design & protocol 

  • Site(s) selection & KOL/PI recruitment

  • Project management & execution

  • Monitoring visits on-site in Israel and globally (if required)

  • Data collection & analysis 

  • Clinical study report

  • Case Report Form CRF/e-CRF, Informed Consent Form (ICF)

  • eTMF (Electonic Master File)

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Literature Reviews

We guide your clinical development with comprehensive research reports

  • Research strategy, plan & scope

  • Literature search, selection, data extraction & analysis 

  • Clinical writing & updates

  • Systematic and narrative literature reviews

  • New applications investigation

  • New protocols investigation

  • Medical guidelines review

  • Scientific literature background for your new product or future research

  • 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

  • Content writing and proofreading

  • Data analysis & visual representation

  • Journal identification, submission & peer review feedback

  • Research articles

  • Opinion pieces

  • Narrative reviews

  • Systematic reviews and meta-analysis

  • Case reports and series

  • Conference presentations & abstracts

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