IVR-IWR Services for Clinical Trials
Interactive Voice Response and Web-board Reporting

Criterium develops telephone scripts and electronic patient diaries (known also as e-PRO or electronic Patient Reported Outcomes) that are customized for the client's protocol and translated into the languages of the countries in which the research will be conducted. Our in-house system recognizes keypad and voice responses to questions, and is compliant to all international standards.

Since its inception, Criterium IVR has been dedicated to developing Interactive Voice Response systems that interface seamlessly with other technologies (such as EDC) to provide data collection and comprehensive management of each clinical study. The Criterium system facilitates the conduct of adaptive trials, which are growing in number each year. A truly adaptive study benefits from Criterium’s applications that collect key data to generate real-time reports with performance metrics for rapid decision-making.

TeleDiaryTM, Criterium's IVR service, provides real-time data tracking for patient recruitment, registration, randomization, patient diaries, and CTM tracking. 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. IWR Wed Board reporting including smart phone or tablet technology component allows all trial collaborators secure access to real-time data via the web. Criterium, a pioneer in utilizing this technology, has been implementing IVRS in clinical trials since 1991.

The Criterium IVR system is capable of handling large call volumes, with no need for additional costly hardware or software capital expenses. Data that is gathered and reported in real-time is used by clients for multiple aspects of the clinical research process, including:

Patient screening, registration and randomization

Routine and just-in-time drug supply and inventory control

Patient diaries with audit trails showing compliance to reporting guidelines

Automated data alerts and checks

Criterium provides a fast deploying, effective solution to gather and report data for clinical development firms of all sizes.

Electronic Patient Diaries

“ePRO” Electronic Patient Reported Outcomes

Using Criterium electronic patient diaries is an effective and efficient method to collect data in real-time from patients during studies. Real-time data provides you full visibility of key trial information, which enables quicker decision-making regarding the progress of a clinical trial.

Prior to the development and implementation of Criterium 's Electronic Patient Diaries, the only option for patients was to keep a daily paper diary throughout the study; they were requested to record symptoms when they experienced them, however, often times the sites and the sponsors questioned when they were filled out.

Thus these paper diaries have several major drawbacks, whereas the Criterium Electronic Patient Diary provides a number of advantages and efficiencies:

Paper patient diaries cannot be tracked for adherence to the reporting schedule; if the patient forgets to complete the diary on the date the symptom occurred, they can complete the diary later, increasing the likelihood that data which is entered is inaccurate.

The IVR protocol often defines a window of time during which the patient reports symptoms that they are experiencing at the moment or within the previous 12-24 hours. Reporting parameters are set depending where on the globe the patient resides. Each patient entry is time stamped with the patient is local time documenting exactly when the call was made.

The data reporting structure surrounding paper diaries is slow, and costly; the diaries are brought in at routine visits in intervals of weeks or months, and the onus is placed on the investigative site to oversee compliance and uncover anomalies in the data. By the time these aberrations are discovered, the patient can no longer remember the correct response and important data is lost which can impact the outcome of the study.

Criterium's ePRO is programmed to generate an alert when data is entered which is invalid or outside accepted ranges. Respondents are immediately prompted to re-enter data. Thus, conflicts are resolved remotely and instantly.

Customized Telephone Scripts

Criterium IVR works with the specific requirements of your protocol to develop a customized script for your clinical study. These scripts are translated into multiple languages as required with both scripting and voice talent appropriate to the region in which the study is being conducted. All scripts contain built in “branching” from which patient responses determine subsequent questions. Sites and patients access the IVR system from around the globe via PIN secured toll-free numbers.

With up to 1300 ports available, the Criterium IVR system has the capacity to accommodate high call-volume loads. The platform is fully redundant, reliable, and scalable. It is designed to seamlessly interface with EDC and all other methods of data collection and meets high-level regulatory compliance requirements and international standards.

Efficient Patient Recruitment and Randomization

Our Interactive Voice Response system is a powerful tool at every stage of the recruitment process:

Outreach and Pre-screening -- Our Interactive Voice Response system can be programmed to be used in combination with clinical trial recruitment advertisements. This provides an easy way for potential patients to call the application to hear all relevant study/patient information. The IVR application can include pre-screening questions and collect patient responses. Based on these responses the IVR system will direct a qualified individual to the nearest participating site. All prescreening information entered can be made available to study personnel including the site, CRO's and sponsors. At each stage the study personnel can monitor and manage patient recruitment into the study.

Screening and Registration -- the Criterium IVR system is programmed to provide immediate counts of patient registrations to sites and project managers. Sponsors can view up-to-date registration figures via our custom online reports or raw information immediately via our web board. The system is a powerful tool to collect real-time recruitment information and report on critical aspects of your clinical trial.

Enrollment and Randomization -- the Criterium IVR system provides an accurate count of patient enrollment as it is happening and enables a sponsor to project a realistic timetable to complete the patient enrollment, randomization and evaluation processes.

Criterium is an experienced provider of all accepted randomization methods including custom algorithms.

During the enrollment process our interactive voice response system collects key patient information to ensure an accurate implementation of the subsequent randomization method. At randomization the interactive voice response system transfers the required information to the investigator. Sponsors also have direct access to this data at every stage of this process.

The Criterium IVR system enables patient recruitment to occur on a global stage; and with its universally available input technology ñ the telephone - (with access via toll-free lines) studies can be tied together across continents and reach out to areas of the world where the greatest number of potential subjects reside.

Efficient Drug Supply Management

The interactive voice response system facilitates a completely automated supply management process. Studies often are global in nature meaning that the trial involves many countries and many sites. This makes supply management a complex logistics and labor-intensive process. Therefore, Criterium's automated supply management enables the sponsor to deal with these matters in an efficient and effective way with less labor and greater inventory control.

The activation of a site allocates an initial allotment of study drug automatically via our supply management solution.

We generate automated inventory reports, and subsequent shipments can be facilitated based on the estimated or actual need for additional supplies at the sites or distribution centers.

The interactive web pages of Criterium provide real-time information on clinical supply management to sponsors.

Criterium IVR: Case Histories and Metrics

Three seasonal allergic rhinitis Phase II and III studies conducted over a period over 5 years. These involved patients calling into Criterium from South Africa. The surveys contained 8-10 main questions, with follow up depending on response:

The first had 619 patients calling in 2x/day for 14 days, and involved 42 South African sites. 17,332 individual calls were logged.

The second had 719 patients calling in 2x/day for 21 days, and involved 36 South African sites. 32,321 individual calls were logged.

The third had 654 patients calling in 2x/day for 21 days and involved 32 South African sites. 27,468 individual calls were logged.

2 major Phase III hormone replacement therapy studies, conducted at 90 USA sites with 1200 patients responding to a 8 main question survey, with customized follow up based on symptoms reported. Patients reported symptoms daily for 90 days. These studies occurred over a period of 2 years. Over 108,000 total calls were logged for these studies.

A hematology study that progressed from Phase II through Phase IV, conducted at 89 international sites with 380 patients. These studies took place over a course of 3 years, and the 12 question survey was customized for both patient history and for patients’ individual symptoms. Patients needed to call every month and when they had a bleeding event. Over 11,800 individual calls were logged.

An Ob/Gyn Phase II and III study in which 380 patients from 40 sites throughout the Western Hemisphere (USA, Canada, Mexico and Costa Rica) responded to a 6 main question survey daily for 14 days. 5,837 calls were logged.

Cost Effective Solutions for Clinical Studies

Criterium clients avoid additional hardware or software capital expenses

Criterium provides fast and economical deployment of our pre-validated high-capacity system

Criterium's interactive voice response system provides 24/7/365 support to sponsors, study coordinators and patients

Criterium's IVR system is able to retrieve detailed information from all over the world via a simple telephone connection.

Criterium's IVR system is compliant with international clinical standards (21 CFR Part 11) with accessibility to complete audit trails.

The Criterium IVR system has the capacity to accommodate high call-volume loads. The system has a fully redundant, reliable, and scalable platform, and is designed to interface seamlessly with EDC and all other methods of data collection.

Criterium IVR 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.

Criterium collects data directly from sites, patients and labs: real-time data and real-time reports provide real-time results.

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 Criterium IVR system maximizes drug supply and inventory control, and continuously monitors patient reporting compliance to protocol requirements.

Criterium IVR provides custom reports to clients as data arrives in real-time. The Criterium IVR 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.

Criterium's IVR applications efficiently perform patient alerts. Patient alerts via interactive voice response, 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 necessary.