Premier Interactive Response Technology (IRT)
We’ve deployed our Premier IRT system on more than 500 Phase 1-4 trials.
Focus more on science, less on administration
Your next drug trial shouldn’t be a study in complexity — and it doesn’t have to be. The Premier IRT system simplifies clinical trial management, improves data security, and easily accommodates your specific study design requirements. Premier IRT offerings include:
- Interactive Voice Response System (IVRS): Voice-based IRT system
- Interactive Web Response System (IWRS): Web-based IRT system
- Electronic Clinical Outcome Assessment (eCOA) Solution: IVRS + IWRS + reporting device of your choice for electronic patient-reported outcomes (ePROs) and other clinical assessments
Our reliable, fully validated 21 CFR Part 11-compliant IVRS/IWRS system incorporates electronic reporting and ePRO capabilities, allowing you to automate many aspects of your trial with flexibility and confidence. That means less stress on investigators and patients alike, and it lets you focus more on science and less on administration.
The Premier IRT system, available as a full-service capability or as a standalone offering, has proven itself on trials throughout North America, Europe, South Africa, Asia, and Australia. It’s backed by a strong, stable team of IRT experts experienced in all facets of interactive response and ePRO systems.
Premier IRT Benefits:
- Fully automated user registration and approval
- Subject randomization and IP dispensing, including centralized, stratified, adaptive, and biased coin algorithms
- Screening, screen failure, washout, and run-in visit tracking — even management of rescue medication
- Early termination, completion, and follow-up visit tracking, including management and dispensing of down-taper medication
- Anytime access to real-time customized reports that can be sorted, filtered, and exported
- Full-range clinical supply management functionality, including automatic reorders, expiry tracking, management of drug returns, and access to unblinded reports
- Diary collection for patients, investigators, and other caregivers through our eCOA “bring your own device” solution
Mobile ePRO/eCOA reporting at your fingertips
With our easy-to-use mobile ePRO application, patient diaries and other eCOA data can be entered on any Android or iOS device. Types of data that can be captured include:
- NPRS (0-10): e.g., Pain on a scale of 0-10
- Five Point Scales: e.g., Always, Often, Sometimes, Seldom, Never
- Yes\No Questions: e.g., Did you take any rescue meds?
- Numeric Values: e.g., How many rescue tablets did you take? How many times did you wake up last night?
Our mobile solution helps ensure compliance and is tightly integrated with our core IRT system within the ePremier Integration Hub, which brings study data and data quality processes together under one platform. Click here to learn more.
Advantages of ePROs
In these unprecedented times, when gathering data remotely is the method of choice, it’s worth making use of ePRO data in your clinical studies to help maintain the integrity of your clinical trials.
The era of non-traditional data sources
Non-traditional data points, in particular real-world data (RWD) and real-world evidence (RWE), are becoming more and more important in the current research climate.