Support

NISCompliance Support & Solutions

CHCUK provides GCP and NIS compliance support to a number of organisations and companies.  The support ranges from performing a compliance gap analysis (“Healthcheck”) on the existing systems and providing solutions and options to bridge gaps, where identified and/or improve the robustness of existing systems and processes; through to providing support in developing Research Governance Departments and Frameworks (NHS), developing SOPs, creating legal acts, training staff and acting as ad hoc consultants:

  • Compliance gap analysis (“healthcheck”)
  • Development of research governance systems and tools
  • SOP review and development
  • Training
  • NIS and GCP Consultants

Regulatory Overviews

CHCUK specialises in summarising the regulatory considerations for your studies, from Phase 0 to Phase 4 studies, whether you’re using diagnostics, radiopharmaceuticals  and/or therapeutics
Our complimentary ‘Regulatory Maps’ provide the user with a visual overview of how the various regulations and guidelines fit together:

Bespoke Reports

CHCUK specialise in producing detailed reports which capture the country-specific regulations and guidelines applicable to your clinical trial or non-interventional study:

  • Non-Interventional Studies – Considerations when Managing and Conducting NIS in Europe (Sample )
  • Informed Consent in Clinical Trials: Europe Part 1 (Sample )
  • We currently cover over the NIS considerations for over 43 countries worldwide, with the database expanding every week.