Criterium Technology

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.

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

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.

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.

The IVR system enables Criterium to provide real-time tracking, notifications and reporting of data to make recommendations based on up-to-the-minute analysis for:

Patient registration
Randomization
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

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.

Features include:

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

Criterium’s unique workflow process, which embraces the role of the clinical data liaison (CDL) is the key to facilitating the communication of data between all stakeholders involved in the clinical trial process. Once data is collected via IVR Interactive Response Systems or IWR Interactive Web Systems, it is transmitted automatically and identically to the final EDC database. Data collected from either voice or web systems will accurately populate both IVR/IWR and EDC systems, thus eliminating the need for users to enter the same information into two different systems. Changes or updates are automatically shared between the systems. Voice-phone and web-based systems interface automatically and immediately with partner EDC solutions. Multiple data collection modes encourage greater subject reporting compliance.

Criterium is able to conduct hybrid virtual studies organized around in-house clinical data liaisons (CDLs) who clean and correct data before the field monitor makes his or her visit to the site and allow patietns to complete clinical assessments from home between site visits. This process streamlines the CRA’s on-site role, which is to troubleshoot patient enrollment and to check source documents and reduces the burden on patients to travel to the office for each study visit.

Because CDLs monitor site data daily, they can identify potential problems before they arise thereby reducing the cost of field monitoring per patient by as much as half when compared with traditional monitoring.

Using real-time data, Criterium hybrid virtual study process connects with the site coordinators and patients, communicates with the monitor, and remotely controls the entire trial. Sponsors maintain control over their budgets by having communications between in-house experts and monitors in the field to more quickly resolve queries early on and lock the database according to the timeline.

In the early 2000’s Criterium made a commitment to using various commercial EDC’s. In 2007, Criterium purchased the IVR platform and continued to revamp it to include IWR and native data on smart phones and tablets, The integration of the interactive platform with various EDCs allows for the collection of clinical trial data from these divergent sources — IVRS, IWRS, EDC, Fax-scannable forms/CRF, and paper forms— into one consistent database. Here the data is available to the client in real-time and can be accessed 24/7 for the purposes of review, updating, distribution, and reporting.

This integrated electronic data capture management process 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.

Our integrated method of electronic data capture collection and management is highly flexible, sets up fast, and is 100% accurate, which equates to a complete data management package.

High level of expertise & high-value technology for every trial

Our Unique Centralized Network Model (CNM) for Translational Research

Seamless interfacing with ancillary support technologies

Criterium Technology

Connect ■ Communicate ■ Control

Connect

Automated Fax Scanning

Electronic Data Capture

Interactive Voice Response

Interactive Web Response

TeleDiary™

Communicate

Clinical Data Liaison

Control

Integrated Data Collection and Management

Clinical Trial Services

CORE Science Solutions

IVR/IWR & ePRO

Get to Know Us!

Contact Us

About Us

Services

Our Experience