Navitas Life Sciences

Full Service Clinical Trial Support to assess a Medical Device on Neurology Patients

Our client, a US based company, needed full service clinical trial operation and strategy support for the design and execution of a medical device clinical trial in subjects with mild cognitive impairment and Alzheimer’s Disease. Their specific goals included:

  • Study protocol development
  • Multiple global site selection
  • Database setup
  • Creation of study documents
  • Management of 12 sites across 3 countries
  • Management of cross-functional vendors
  • Clinical Monitoring and Regulatory Support
  • Support Database Lock 
  • Statistical Analysis
  • Preparation of clinical study report
  • Audit Readiness of Sites

Please complete the form to download the Case Study and learn how we worked seamlessly with our client to deliver efficient and effective full-service clinical trial support for this study.


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