ProPhase, LLC Information

ProPhase is a global provider of specialty services focusing on applied measurement in CNS (psychiatry, neurology and rare/orphan diseases) as well as other indications in the healthcare spectrum (oncology, dermatology, etc.), which require calibration of observational assessment. Through collaboration and evidence-based innovation, we work to transform measurement science in clinical trials and improve outcomes for all stakeholders. Our services support all measurement-related activities in clinical trials: • Protocol Consultation and Measurement Selection • Scale Development and Validation • Scale Management (licensing, linguistic validation and distribution) • Rater Qualification and Training • In-Study Clinical Quality Assurance / Surveillance (data, audio, and video) • Statistical Analysis and Reporting By partnering with Sponsors, CROs and sites, and using a risk-based approach, we deliver services that are highly customized to study needs, and adapted regionally for global trials. We have access to multiple technological mediums, with proven success with audio, video, hand-held tablets and a variety of other devices for data collection, analysis and reporting. We have successfully supported trials in more than 60 countries, in all phases, across 18 primary indications, including mood disorders, anxiety disorders, psychotic disorders, and neurological disorders, such as Alzheimer’s, Huntington’s, multiple sclerosis, and Parkinson’s. We have extensive experience in trials with pediatric populations and unique expertise in supporting trials in orphan indications/rare diseases, such as Down syndrome, Fragile X, San Filippo, Pompe, Hunter, metachromatic leukodystrophy, phenylketonuria, and others.