Non-interventional Studies

Driving Outcomes for PASS, PAES and other Non-Interventional Studies

Real-world evidence of drug use in various patient populations is essential to understanding the value of a therapy. The expectations and demands of a non-interventional study are manifold:

  • Quality of data must remain high: non-interventional study data has been used to support marketing authorization
  • Post approval drug costs are estimated at $312 million. Yet cost expectations around non-interventional studies are low, given lower risk of such studies and reduced need to comply with GCP
  • Regulations around non-interventional studies are not harmonized around the world, requiring highly experienced staff to conduct studies

However, the real-life situation of such post-authorization studies makes them inherently complex, requiring advanced data handling capability for successful outcomes.

Our NIS Team is Backed by an Exclusive Technology Platform

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:

  • study-experience

    Study Experience

  • experienced-team

    Experienced Team

  • cost-efficiency

    Cost Efficiency

  • flexible-engagements

    Flexible Engagements

  • proprietary-technology

    Proprietary Technology

Our services are enriched by our:

  • Experience in multiple types of post-marketing studies: market surveys; pre-launch screenings; classic observational studies; post-authorization studies (in safety and efficacy); 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 minimizing 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
  • OneClinicalLite : A proprietary, web based, system designed specifically for capturing large volumes of non-interventional study data with full audit trail capability
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