Clinical Neuroscience

Neuro Imaging

  • Screening,Safety Imaging and Biomarkers
  • Standardisation Support and Management
  • Central Reading is the only option to avoid inconsistencies and bias
  • Independent Reviewers with trial reading expertise
  • Single Method measurements
Radiologic Imaging has become more important in Neuroscience Clinical Trials, as Pharma/Biotech trial protocols show an increase of endpoints that are related to Medical Imaging. An Imaging endpoint is often not listed as the primary endpoint, is commonly listed as secondary endpoint or is intended for a subgroup of subjects. Regulatory agencies are more frequently demanding that Pharma-Research includes Radiologic scans. The Imaging is performed for screening, safety monitoring and as a biomarker for trial drug activity (disease staging/efficacy). In general the Radiologic Imaging is MRI, PET or CT (or a combination of those modalities). Standardisation is the key for making sure that image review and measurements guarantee comparable datasets. NeuroScios offers 13 years of experience in standardisation in multiple site trials.

This includes the following services:
  • Protocol development support / Imaging Protocol Consultancy
  • Site training (Technologists and Radiologists)
  • Image collection, Quality Control and Central Reading/ measurement services
  • Third party collaborations or multiple imaging vendor management/oversight
  • Data exports and statistical analysis support
 

Neurological testing

The drug development for AD is characterized by continuous failures to show clinical effects and improvement of cognitive function since more than 10 years. Enormous financial and research effort has put into the development of new compounds and in spite of sometimes encouraging data from Phase II clinical testing, the final proof of efficacy failed. Have the wrong compounds been selected for the clinical development? – Most likely, yes!

A reason could be the use of wrong instruments to investigate cognitive effects in early trials. Almost all new substances underwent intensive animal testing in the most widely used cognitive paradigm, the Morris water maze, assessing spatial orientation. How to translate these findings in to human application?

Our experts have  more than 50 years’ experience of Alzheimer’s disease and other cognitive disorder clinical drug trials, gained at all stages of development.

We can assist your drug development program with:

  • The direct way for drug development for cognitive disorders: from laboratory research to clinical validation
  • Cognitive testing and training of raters
  • Data analysis and Interpretation

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