NIS Regulatory Consulting

CHCUK experts are on hand to answer your ad hoc questions, review or help build your NIS quality system, protocols or training materials.  We’re here to help.

Once you step outside the research world of clinical trials life becomes challenging.  There isn’t an ICH Guideline that you can refer to for comprehensive guidance on what a non-interventional study (NIS) is and how to conduct one.

NIS Regulatory Consulting
It’s a story we know well.  It’s why we setup CHCUK back in 2009.  Stuart McCully, our founder, was trying to run/support non-interventional studies and struggled to find information or support.  After approaching Regulatory Affairs, Pharmacovigilance, Clinical Operations and QA groups and drawing a blank, it was clear there was a regulatory intelligence and operational support gap that needed to be addressed for non-interventional studies.

The past decade has seen the market access pathway for medicinal products evolve and mature beyond just needing regulatory approvals for marketing authorisations. Receiving a marketing authorization is no longer enough; you also need to secure reimbursement for your product.

Non-interventional studies are one of the many tools used to produce real world evidence to support value statements for products. Two key areas NIS are used to address are the benefit/risk profile of the product in the real world setting (e.g., Post-Authorisation Safety Studies) and how effective the product is i.e., does the product do what it is supposed to do when used in patients that (unlike in clinical trials) are taking multiples of drugs (concomitant medications) and suffer from various conditions (comorbidities).


Areas covered
  • Non-interventional studies (with approved drugs)
    • Product registries
    • Retro/prospective chart reviews
  • Disease registries (no drug)
  • Pregnancy registries
  • Low intervention trials (clinical trials with similarities to NIS design)
  • Pragmatic clinical trials (comparative effectiveness trials)
Examples of consultancy work offered
(includes but not limited to)
  • Study classification
  • Regulatory compliance gap analysis/ healthcheck
  • Country-specific and study-specific regulatory requirements
  • Study conduct considerations and support
  • Study design
  • Protocol development/ review
  • SOP development/ review
  • Biosampling and biobanking
  • Genetic research
  • Use of technology in NIS e.g., BYOD
  • Training and Education
  • Subject Matter Expertise
  • Workshops
Countries covered (63)
(The country list is always expanding)
Argentina, Australia, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, China, Columbia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Japan, Kazakhstan, Latvia, Lebanon, Lithuania, Luxembourg, Macedonia, Malaysia, Mexico, Netherlands, New Zealand, Norway, Pakistan, Paraguay, Peru, Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Switzerland, Taiwan, Tunisia, Turkey, UAE, UK, Ukraine, Uruguay, USA, Vietnam