- 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 biomarkers 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