Identification of the best available sources for the study, utilizing SPIFD framework
regulatory compliant data sets
Development of preliminary gaps assessment for areas with additional procedures and quality control needs
Proprietary data model to convert source data
Clinical data to address clinical questions
Full legal compliance (GDPR, HIPAA)
Study protocol design consulting
Producing high-validity RWE
Quality management system (QMS) in RWE setting
Submission to institutional review board / independent ethics committee approval
Final / clinical study report development