Compliance 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.
