Connect ■ Communicate ■ Control
At Criterium, “Connect, Communicate, and Control” represents our approach to keeping clinical trials efficient and cost effective.
Using state-of-the-art technologies and real-time information, we connect stakeholders to data sources, control studies by transforming data into decision-making information, and communicate with all stakeholders and team members.
Our reputation as a leading contract research organization comes in part from our ability to use technology to tailor clinical development to each client’s needs.
Traditional and Virtual Clinical Trials
Criterium connects its network of staff, contractors, partners, investigative sites, and patients using an array of technologies— Smart CRFs, IVR, EDGE (Electronic Data Global Entry), and TeleDiary™— and consolidates all input to allow Criterium to manage studies traditionally and in a hybrid of virtual clinical studies.
Automated Fax Scanning
Historically, Criterium’s fax form technology converts a paper-based system at the investigative site to an in-house automated data storage system for:
- Case report forms
- CRF corrections
- Fax surveys
Electronic Data Capture
Criterium also designs custom web forms. Criterium provides a secure online connection for entering clinical site data directly into the study database. This information from various sources is managed and reviewed within the context of each 21 CFR Part 11 EDC system used.
Interactive Voice Response
Criterium has true telephony expertise for remote site, data and patient management. Using IVR systems combines the process of collection, correction, and reporting to provide an audit trail that is not possible with standard paper diaries.
Criterium offers Interactive Technology both as part of a comprehensive study management plan, or for a single service.
- Patient registration
- Direct data from patients: patient Reported Outcomes (ePRO) and electronic clinical outcomes assessment (eCOA)
- Clinical trial materials management with just-in-time investigational drug delivery
Interactive Web Response
Criterium’s secure Interactive Web Response (IWR) computer servers provide powerful functionality to telephone–based and Internet-drive applications.
Both IVR and IWR interact simultaneously with the databases that direct and record study processes. Sites can view patient calls (date, time of call, dose time) and direct-to-Web patient data entry in real time. Sites can also view final patient diary reports and print patient confirmation of randomization.
Criterium’s IVR-based TeleDiary, an electronic patient diary and Web-based response system, has proven to be more efficient and cost-effective than standard paper diaries. Additionally, TeleDiary is a superior method to paper diaries for obtaining data and maintaining the integrity of data.
TeleDiary‘s real-time reporting systems incorporate built-in compliance feedback involving communication with enrolled subjects and designated site/study personnel via automated messages, SMS text messages, web reporting and emailed/faxed reports. Alerts can be released after meeting only certain pre-programmed conditions.
- Real-time patient reporting
- Automatic data edit checks
- Algorithms customized per protocol
- Multilingual translations
- Automatic study qualification reporting
- PIN security
- 24/7/365 international toll-free availability