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IVR-IWR-IXR & ePRO
Services for Clinical Trials
Since its inception, Criterium has been dedicated to developing Interactive Voice Response (IVR) and Web-Board Reporting systems (IWR) systems that interface seamlessly with other technologies (such as EDC) to provide data collection and comprehensive management of each clinical study. Criterium’s applications collect key data to generate real-time reports with performance metrics for rapid decision-making.
These IXR services provide real-time data tracking for patient recruitment, registration, randomization, patient diaries (ePRO), and CTM tracking. Remote data management using IXR combines the process of collection, correction, and database locking, as well as an audit trail not possible with paper patient diaries. Wed Board Reporting (IWR) including smart phone or tablet technology allows all trial collaborators secure access to real-time data via the web.
We apply our systems when working with our Oncology consortia and large academic institutions, innovative specialty biotechnology companies, medical device companies, healthcare groups, and EDC technology providers around the globe. Our application is highly scalable and able to accommodate small individual site IIT studies up to large multi-national trials with unlimited numbers of sites, subjects, and modalities, with varying complexities.
ePRO: Electronic Patient Diaries
ePRO: Electronic Patient Diaries
- Real-time data provides full visibility of key trial information, enables quicker decision-making
- Patient diaries with audit trails show compliance to reporting guidelines
- Patient entry is time stamped
- Generates an alert when data is entered
- Conflicts are resolved remotely and instantly
Customized Telephone Scripts
Customized Telephone Scripts
- Customized to protocol-specific requirements
- Scripts translated into multiple languages
- All scripts contain built in “branching”
- PIN secured toll-free numbers
- Capacity to handle high call-volume loads
- Fully redundant platform: reliable, and scalable
- Seamless interface with EDC & all other data collection methods
- Meets high-level regulatory compliance requirements & international standards
Efficient Drug Supply Management
Efficient Drug Supply Management
- IVR system manages complex logistics and labor-intensive process
- Completely automated supply management is efficient and effective
- Less labor and greater inventory control
- Interactive web pages provide real-time info on clinical supply management
- Site activation allocates an initial allotment of study drug automatically
- Routine and just-in-time drug supply and inventory control
- Generates automated inventory reports
- Shipments occur based on estimated or actual need for supplies at sites or distribution centers
Outreach and Pre-screening
- Programmable to be used in combination with clinical trial recruitment advertisements
- Potential patients can call the system to hear all relevant study/patient information
- Includes pre-screening questions and collects patient responses
- Based on these responses the IVR system directs a qualified individual to the nearest participating site
- All prescreening information is available to study personnel, site, CRO and sponsor
- Powerful tool to monitor and manage patient recruitment into the study
Patient Screening, Registration & Randomization
- Experienced provider of all accepted randomization methods including custom algorithms.
- Collect subject information to automatically compare to pre-loaded inclusion/exclusion criteria.
- Uses collected key patient information to ensure accurate implementation of the randomization method
- Implementing wide range of simple to complex randomization methods
- Programs randomization schemes by protocol specifications
- Manually or automatically generate patient/subject IDs
Enrollment and Randomization
- System provides accurate count of patient enrollment as it is happening
- Enables a sponsor to project a realistic timetable to complete the patient enrollment, randomization and evaluation processes
IXR clients have command over study costs by minimizing over-recruitment, maximizing patient compliance and reducing monitoring visits – all factors that affect study timelines and budgets.
- Avoid additional hardware or software capital expenses
- Provides fast, economical deployment of pre-validated, high-capacity system.
- 24/7/365 support to sponsors, study coordinators and patients
- Collects data directly from sites, patients and labs
- Retrieve detailed information world-wide via a simple telephone connection.
- Compliant with international clinical standards (21 CFR Part 11)
- Complete audit trails
- High call-volume load capacity
- Fully redundant, reliable, scalable platform interfaces seamlessly with EDC and all other methods of data collection
Optimized Communication Flow
Sites receive data in real-time from Criterium via secure web access. Criterium IVR provides real-time data tracking and management of patient registration, automated randomization, diary compliance and improves overall clinical trial management.
The IVR system maximizes drug supply and inventory control, and continuously monitors patient reporting compliance to protocol requirements.
Criterium’s IVR provides custom reports to clients as data arrives in real-time. The system also contains automated data checks to instantly resolve responses that are out of expected ranges.
The Criterium IVR system also provides real-time statistics that are superior to paper diary capabilities.
Patient alerts via IVR, short message service (SMS) and voice mail are the most cost efficient and effective ways to reach the patient. By using the interactive voice response system, patients can be alerted for medication dosing and appointment reminders, and other notifications as needed.
High level of expertise & high-value technology for every trial
Our Unique Centralized Network Model (CNM) for Translational Research
Clinical Development tailored to each client’s needs