In eClinical industry parlance, configurable IRT typically means fast, but inflexible with limited functionality, while customizable IRT suggests costly and slow development, but ultimately tailored to the protocol.
At YPrime, we’ve married the two approaches for maximum benefits. Comprehensive configuration handles most IRT functions, while ensuring a consistent user experience. Customization is always available to support unique, protocol-specific requirements of today’s complex clinical trial design.
Configuration offers scores of benefits related to cost-effectiveness, development speed and execution flexibility.
- The ability to make changes after go-live with minimal programming and reduced time for validation
- Protocol amendments are a fact of life in today’s clinical trials. So is the need to support ever-expanding protocol complexity, and the ability to make changes quickly. Configuration is especially beneficial for adaptive designs with flexible protocols, from early dose escalation to confirmatory trials
- Modular components of configurable systems can be quickly updated, based on the needs of the new protocol. Cycle time to go into production is much shorter because the modules are pre-validated
- Configurable IRT systems allow the end user to update dose scheming from patient-to-patient and visit-to-visit. What’s more, this functionality is controlled by the end user, eliminating the need to enlist the helpdesk, project manager or generate a change order