Prevail’s intuitive EDC software brings big-company data management functionality to any company. Benefit from timely and efficient data review, SDV, query generation and resolution to shorten the path to database lock.
With Prevail’s EDC software, all of a patient’s data is entered through the Visit Schedule Manager (VSM). It’s fast and easy to navigate since each eCRF is accessible in the VSM’s grid and is arranged based on the study schedule.
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 such as GDPR as well as HIPAA.
Enables easy CRF configuration with a library of validated CRFs to choose from, along with CDASH forms.
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.
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.
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.
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.
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.
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.
Learn how Prevail’s EDC can help make your study a success.