Clinical Studies: Planning, Technical & Ethical Document's Management

doctor writing

Clinical Planning & Management

  • Research planning
  • Methodological and normative adequacy
  • Protocol design
  • Statistical plan, sample design and size
  • End-point definition
  • ITC (Information and Communication Technologies) solutions for randomizing
  • Treatment allocation
  • Data collection
  • Cost-efficiency and risk-benefit analysis
  • Statistical methodology design
  • Design and realization of paper CRF (Case Report Form) on paper/electronic support
  • Documentation for Ethics Committees (EC)

Trial and Site Management and Monitoring

  • Site recruitment
  • Start-up activity
  • Ethics committees: authorization requests and management
  • Administrative authorizations
  • Start-up and monitoring of on-site and remote clinical experimentations
  • Monitoring
  • Process control and follow-up

Clinical Data Management and Medical Writing

  • Data collection & Data entry
  • CRF and eCRF processing
  • Data validation and verification
  • Data transfer and codification
  • Data monitoring
  • Statistical analysis
  • Study reporting
  • Scientific posters and paper

cro4Q, according to EU regulatory system, offers a complete service of technical document writing and management, both for Medical Devices EC marking or medicines registration (Clinical Evaluation Report, Expertise, Position Paper and Risk Analysis) and for clinical studies and post-marketing evaluation of effectiveness and security (product commonly used in the clinical practice).

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