orphan reach is more than just another CRO, it is a rare CRO. We offer bespoke service solutions for orphan drug developers that mould into our client’s needs and provide them with just the right service mix from obtaining orphan drug designation through to conducting registry studies.
Our service is built around the patient and what we can contribute to improve their lives along their difficult journey.
– Regulatory Strategy Planning
– Orphan Designation Applications
– Break Through Designation Applications
– Orphan drug designation
– Pediatric Priority Review Vouchers
– FDA and EMA Meeting Preparation and Representation
– Patient Advocacy Group strategic planning
Natural history (NH) studies are an important tool for understanding the etiology, range of manifestations, and progression of rare diseases. Well conducted NH studies can yield information on biomarkers and other correlates of clinical outcome. Obtaining maximum value to support drug development programs depends on conducting these NH studies early, long before potential therapeutic agents are identified for development. Comprehensive, good quality NH studies designed with an eye toward supporting drug development programs can avoid some of the common problems that lead to stalled, slow, or inefficient drug development for rare diseases.
We offer the whole spectrum of clinical development services in:
• Project Management
• Quality Assurance
• Medical Writing
• Regulatory Affairs
• Drug Distribution
• Clinical Monitoring
• Medical Monitoring