Need support with Clinical Evaluation or Clinical Studies?

Our services

Clinical Consultancy

  • Clinical development plan
  • Sufficient Clinical Evidence
  • MDR readiness and implementation
  • Clinical Evaluation Plan (CEP)
  • Literature review
  • Clinical Evaluation Report (CER)
  • MEDDEV 2.7/1 rev 4 compliance
  • Clinical problem solving
  • Training
  • Clinical Audit
  • Worldwide support

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Interim Clinical Support

  • Temporary support
  • Replacement
  • On-site or remote
  • Clinical department development
  • Coaching and training
  • Clinical Study Management
  • Site Monitoring
  • Alignment with QA/RA and marketing roles

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CRO services

  • ISO 14155/ GCP compliance
  • Pre-CE study design and management
  • PMCF study design and management
  • Define Study Endpoints
  • Protocol/ CIP development
  • Investigator Brochure
  • Case Report Form (CRF)
  • Informed Consent (ICF)
  • CA/ EC  submission
  • Site selection, training, and management
  • Monitoring
  • Statistics
  • Data management
  • EDC selection
  • Audits
  • Remediation of non- compliant studies

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