We are Process Experts

Using state-of-the-art, customized data-management technology, our experienced and knowledgeable staff oversees each project to make critical decisions with real-time data. Based on the specific needs of the client, Criterium will provide a comprehensive solution to ensure the best outcome and a successful trial.

StudyControl™

• Our highly experienced data management and technology teams manage the clinical trial work flow using StudyControlTM, Criterium’s innovative proprietary technology that integrates systems and processes — IVRS, EDC, Fax-scannable forms/CRF, and paper forms (if/when necessary).
• StudyControlTM operates through a secured VPN and is designed to meet high-level regulatory compliance requirements.
Criterium’s system can accommodate any reporting or organizational need.
• StudyControlTM is highly flexible, sets up fast, and is 100% accurate, which equates to a complete data management package.
• The end result: significant time and cost savings for your study.]

Automated Fax Scanning

• Criterium’s fax form technology converts a paper-based system at the site to an automated, seamless flow of data and electronic image storage system in-house. This system is inexpensive to implement and saves monitoring costs accrued in “traditional” practice. Criterium uses this method for case report forms
• CRF corrections
• Fax surveys
• Image management

Metrics: Time is of the essence to capture clean data

6 sites are represented; 3 with FaxForms and 3 with traditional monitoring. Patient enrollment is close to identical (61 FF/ 58 Traditional—dark blue). With no significant difference in number of queries/10 patients (blue), there were SIGNIFICANT differences in the avg. number of days to complete queries (43 vs. 99 – light gray); also significant were the differences in Monitoring Visits (21 vs. 41 – dark gray), and the differences in Monitoring Visit Days (33 vs. 86 black). Thus, not only are there fewer monitoring visits when the FaxForm system is used, but each monitoring visit is significantly shorter. The overall reduced time on site by monitors results in significant savings

Metrics: Lower costs to complete study

The cost per Monitoring visit is significantly less at FaxForm monitored sites ($1900 vs. $2300 – blue), as cost/monitoring day is equal at about $1350/day (red). The Field Cost per patient (green) is about $750/patient under the FaxForm system vs. $1750 for traditionally monitored sites. Thus, a monitor operating with FaxForms should be more efficient and should be able to manage up to 2.5 times the number of sites vs. those using the traditional approach.

Interactive Voice Response

Criterium’s IVR services provide real-time data tracking for patient registration, randomization, patient diaries, and CTM. Remote data management using IVR combines the process of collection, correction, and database locking, as well as provides an audit trail not possible with paper patient diaries.

Interactive Web Response

Criterium's secure Interactive Web Response (IWR) computer servers provide powerful functionality to both 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.

Electronic Data Capture (EDC)

Criterium designs custom HTML forms to gather user-generated data; these data can then be incorporated directly into a working database. Utilizing ASP and ASP.NET technology, Criterium provides secure online data entry capabilities for gathering clean clinical data that are stored directly into the study database where they information is managed and reviewed using StudyControl™.