Electronic Data Capture &
Clinical Data Management System

Prevail’s Electronic Data Capture (EDC) has served thousands of study centers, from clinics to most major academic hospitals, in six continents and in all phases of studies for over 10 years. Sponsors trust it and Prevail’s Clinical Data Management (CDM) system to collect and clean the data they need. Sites trust it to make their lives easier.

Product Review

Prevail’s EDC & CDM are purpose built to facilitate ease of entry for clinical site users, and to enable timely and efficient data review, SDV, query generation and resolution to shorten the path to database lock. Automated study-specific workflows guide site users to record data in the eCRF in compliance with the study schedule of assessments. Task-based monitoring and data management modules with built-in status reporting drive the continuous data review and cleaning. The system automates labor intensive activities to ensure minimal hours are used for low level data management and more attention can be paid to higher-level review. The monitoring and query management functions support both on-site and remote monitoring practices. Reporting engines provide visualizations of the clinical and diagnostics results for each patient trended over time.

The platform structure is object based with data access and controls built into the objects. Above that, there is a data access library with shared application functions for user and role management, and communications across applications. On top of that are the business level applications using a common access library. The Single Interface is accessible from your device (PC, tablet PC, iPhone/iPad, etc.) using commercially available browsers. The system allows for study schedules with multiple patients types, long follow-up schedules and multiple studies. Praised for its ease-of-use, the underlying EDC and CDM technology infrastructure has also been audited by the FDA and successfully passed inspection with no 483 or warning letters.

Prevail’s EDC & CDM are purpose built to facilitate ease of entry for clinical site users, and to enable timely and efficient data review, SDV, query generation and resolution to shorten the path to database lock. Automated study-specific workflows guide site users to record data in the eCRF... More

Prevail’s EDC & CDM are purpose built to facilitate ease of entry for clinical site users, and to enable timely and efficient data review, SDV, query generation and resolution to shorten the path to database lock. Automated study-specific workflows guide site users to record data in the eCRF in compliance with the study schedule of assessments. Task-based monitoring and data management modules with built-in status reporting drive the continuous data review and cleaning. The system automates labor intensive activities to ensure minimal hours are used for low level data management and more attention can be paid to higher-level review. The monitoring and query management functions support both on-site and remote monitoring practices. Reporting engines provide visualizations of the clinical and diagnostics results for each patient trended over time. The platform structure is object based with data access and controls built into the objects. Above that, there is a data access library with shared application functions for user and role management, and communications across applications. On top of that are the business level applications using a common access library. The Single Interface is accessible from your device (PC, tablet PC, iPhone/iPad, etc.) using commercially available browsers. The system allows for study schedules with multiple patients types, long follow-up schedules and multiple studies. Praised for its ease-of-use, the underlying EDC and CDM technology infrastructure has also been audited by the FDA and successfully passed inspection with no 483 or warning letters. Less

Product Features

Regulatory Compliance

The system is compliant with FDA’s 21 CFR Part 11, Annex 11 and ICH GCPs guidelines. In addition, patient information can be maintained according to EU Privacy Laws as well as HIPAA.

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The system is compliant with FDA’s 21 CFR Part 11, Annex 11 and ICH GCPs guidelines. In addition, patient information can be maintained according to EU Privacy Laws as well as HIPAA.

Easy CRF Configuration

Enables easy CRF configuration with a library of validated CRFs to choose from, along with CDASH forms.

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Enables easy CRF configuration with a library of validated CRFs to choose from, along with CDASH forms.

Complex & Multivariate Queries

Define search criteria on any piece of data that is collected and integrated and produce listings. Also, the data validations are defined in a cross dataset manner. Front-end and back-end edit checks along with... More

Define search criteria on any piece of data that is collected and integrated and produce listings. Also, the data validations are defined in a cross dataset manner. Front-end and back-end edit checks along with automated queries and staggered CRF input allow for minimal query production and the system allows for flexibility in adjusting to specific site needs. Less

Define search criteria on any piece of data that is collected and integrated and produce listings. Also, the data validations are defined in a cross dataset manner. Front-end and back-end edit checks along with automated queries and staggered CRF input allow for minimal query production and the system allows for flexibility in adjusting to specific site needs.

Training & Support

Train team members via in-person, WebEx or training video sessions. There are also “train the trainer” materials for CRAs and Quick Reference sheets for sites. Support is provided via email, chat or phone in... More

Train team members via in-person, WebEx or training video sessions. There are also “train the trainer” materials for CRAs and Quick Reference sheets for sites. Support is provided via email, chat or phone in whichever time zones are needed for the study. Less

Train team members via in-person, WebEx or training video sessions. There are also “train the trainer” materials for CRAs and Quick Reference sheets for sites. Support is provided via email, chat or phone in whichever time zones are needed for the study.

Flexible Exports/Transfers

Data and reports are exportable in a number of formats, including SAS and Excel. Clinical data sets are designed on the CDISC ODM format and data set delivery in SDTM and ADaM formats can also be supported.

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Data and reports are exportable in a number of formats, including SAS and Excel. Clinical data sets are designed on the CDISC ODM format and data set delivery in SDTM and ADaM formats can also be supported.

Alerts

Data waits for you while intelligent information finds you – alerts can be set-up according to certain triggers or algorithms to ensure that the right people are alerted at the right time.

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Data waits for you while intelligent information finds you – alerts can be set-up according to certain triggers or algorithms to ensure that the right people are alerted at the right time.

Auto-Encoding

Allows for auto-encoding of Concomitant Medications and Adverse Events with the latest versions of MedRA and WHO Drug, while allowing manual encoding of any remainders.

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Allows for auto-encoding of Concomitant Medications and Adverse Events with the latest versions of MedRA and WHO Drug, while allowing manual encoding of any remainders.

Usability

The system can be displayed on any system and any browser while auto-adjusting forms based on entries already made and auto-populating fields to minimize data-entry efforts by site personnel. Queries are easily... More

The system can be displayed on any system and any browser while auto-adjusting forms based on entries already made and auto-populating fields to minimize data-entry efforts by site personnel. Queries are easily displayed for monitors to ensure efficient monitoring. Less

The system can be displayed on any system and any browser while auto-adjusting forms based on entries already made and auto-populating fields to minimize data-entry efforts by site personnel. Queries are easily displayed for monitors to ensure efficient monitoring.

See Prevail's Electronic Data Capture &
Clinical Data Management System at work

Prevail's Electronic Data Capture &
Clinical Data Management System can be implemented with The Single Interface™ for use in various industries. See how it works with these customers.

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Clinical Data Management System

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