Criterium connects its vast 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 using StudyControl™. Criterium’s technology systems are 21 CFR Part 11 compliant and validated.
Criterium’s fax form technology converts a paper-based system at the investigative site to an in-house automated data storage system . This system is inexpensive to implement and saves monitoring costs accrued in traditional practice. Criterium uses this method for:
Criterium’s EDGE (Electronic Data Global Entry) is its proprietary EDC system. EDGE is a state-of-the-art technology that maximizes worldwide data collection and management in real time. EDGE has control features not available on paper CRFs, resulting in fewer data entry errors and fewer queries to the sites. EDGE is a perfect solution in a hospital or practice setting in a developing country where the local infrastructure does not support direct EDC entry. EDGE incorporates Criterium’s Smart CRFs, which can then be faxed into StudyControl™ where the data are integrated directly with data from sites using EDC.
Criterium also designs custom web forms. Utilizing ASP and ASP.NET technology, Criterium provides a secure online connection for entering clinical data directly into the study database. This information is managed and reviewed using StudyControl™.
Criterium’s IVR systems provide real-time data tracking for:
Remote data management using IVR systems combines the process of collection, correction, and database locking, and provides an audit trail that is not possible with standard paper diaries.
Criterium offers IVR both as part of a comprehensive study management plan, or for a single service. The IVR system enables Criterium to provide daily tracking and reporting of data, and make recommendations based on up-to-the-minute analysis.
Criterium’s secure Interactive Web Response (IWR) computer servers provide powerful functionality to telephone-based and Internet-drive applications. Both interfaces interact simultaneously with the databases that direct and record study processes. Sites will be able to view patient calls (date, time of call, dose time) in real time. Sites can also view final patient diary reports and print patient confirmation of randomization.
Criterium’s case report forms are smart — they talk to each other. Whether electronic or paper, fields are preprogrammed to be tied directly into StudyControl™ and integrated with patient data from other sources (ECG, LAB, IVR).
Criterium’s 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. Numeric data are available immediately; voiced qualitative data are compiled and available the next day.
TeleDiary™ involves no new hardware or software expense or maintenance by the client. Criterium personnel design the questionnaire and program all applications into a secure computer system. Patients record their responses via a touch-tone keypad into that computer via secured toll-free numbers. All information reported in an IVR diary is available to our clients and sites as it is being gathered through Criterium’s secure Web Access or Virtual Private Network (VPN). Clients also have the advantage of Criterium’s 24-hour help desk, with worldwide support for their studies. TeleDiary™ features include: