Case In Point
IRT Support for a Long-Term, Complex Rare Disease Study
About Client
The sponsor is conducting a global, open-label extension (OLE) study involving children and adolescents with a rare neurological disease. The study enrolls patients rolling over from prior Phase II and III studies and requires long-term, frequent dosing and site or home-based visits per protocol.
Everest has served as the Interactive Response Technology (IRT) provider for this program for over 7 years.
Challenge
The study faced several complex operational and logistical issues, including:
- Limited drug supply availability and tight expiration timelines
- Complex shipping logistics across multiple countries and protocols
- Need for individualized patient scheduling and flexible dosing pathways
- Requirement to manage weight-based dosing, titration, and tapering
- Restrictions based on country-specific or protocol-specific treatment pathways
- Need for full traceability and accountability in drug management and delivery
Solution
Everest IRT implemented a comprehensive, adaptive solution to support the trial’s requirements:
- Supported weight-based dosing, dose titration into OLE, and tapering at discontinuation
- Introduced variable dosing and assignment models, including: site-level assignment, site-to-patient shipments, and direct depot-to-patient shipments
- Designed system enhancements to support partial treatment assignments and time-sensitive resupply triggers
- Drug receipt, returns, usage, and destruction tracking
- Integrated Everest IRT with Medidata Rave EDC at specific timepoints to facilitate data synchronization and support timely data entry
Results
- Enabled the study to continue dosing despite drug supply and expiration constraints
- Maintained protocol compliance across multiple global sites and varying country-specific restrictions
- Delivered a flexible, patient-centered dosing and logistics approach that supports ongoing trial execution
- Ensured full traceability and accountability for drug supply across the lifecycle of treatment
