Real world evidence of drug use in various patient populations is essential to understanding the value (benefit/risk profile) of a therapy. NIS’ inherent complexity given their real-life situations poses challenges for sponsors to strike a desirable balance between cost and quality. The expectations and demands of an NIS are manifold:

  • Quality of data must remain high: non-interventional study data has been used to support marketing authorisation
  • Post approval drug costs are estimated at $312 million. Yet cost expectations around NIS are low, given lower risk of NIS studies and reduced need to comply with GCP
  • Regulations around non-interventional studies are not harmonised around the world, requiring highly experienced staff to conduct studies
  • Real-life situation of studies makes them inherently complex, requiring advanced data handling capability

Navitas Life Sciences Is Here to Help

Navitas brings its passion for delivering speed with no compromise on quality to every engagement, enabling you to increase efficiency in NIS studies, minimise the risks to study success and patient safety, and deliver high quality data, faster. Our services are enriched by our:

  • Experience in multiple types of post-marketing studies: market surveys; pre-launch screenings; classic observational studies; post-authorisation safety and efficacy studies; risk management effectiveness studies and compliance studies
  • Dedicated NIS team, with NIS specific SOPs and experience in challenging therapeutic areas including Multiple Sclerosis, Alzheimer’s disease, Huntington’s Disease, oncology, cardiology and many others 
  • Focus on minimising complexity to reduce cost, maintain patient safety and achieve study goals
  • Flexibility and adaptability to your needs: completed studies we have engaged in have ranged in patient numbers from <50 to >26,000, globally and locally
  • Proprietary, web based, system designed specifically for capturing large volumes of NIS data with full audit trail capability
  • Optimized and efficient trial conduct and analysis platform, OneClinical

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