Clinical Research Management
OnCore
Online Collaborative Research Environment is an enterprise wide clinical research management system (CTMS) developed by Advarra. The OnCore application can be used to manage all aspects of human subject research from facilitating study enrollment, enrollment tracking, and through the direct connection to the Analytics platform robust reporting capabilities as well as eREG electronic regulatory binder. Access to Studies and data in OnCore is driven by roles that concentrate the information and activities relevant to different staff roles.
For more information contact Lisa Palmer and/or Dan
OnCore functionality includes but is not limited to:
· Study Setup and Activation with accrual monitoring
· Program generated randomization schema
· Study Tracking and management of IRB submissions and study staff
· Consent version tracking by subject
· Notifications for re- consenting and age of majority
· Visit tracking and dates
· Facilitate revenue capture and billing for missed visits and pass-through costs
· Supports remote monitoring, source uploads and audit trails
Electronic Regulatory Binder (eREG)
Advarra eReg is a 21 CFR Part 11-compliant electronic regulatory management system that is utilized for managing all required regulatory documents for human subject research. eREG integrates with the OnCore application and with CIRB for information transfer across platforms.
For more information contact Dan
EREG functionality includes but is not limited to:
· Manage credentials and document expiration dates
· Share/update documents and records across multiple protocols
· Manage multi-site trials from one location
· Route Electronic delegation of authority and training logs for e-signatures
· Remote monitor study
· Email integration (emails can be sent directly to study e-binder)
· SOC2, HIPAA, 21 CFR Part 11, and NIST 800-53 compliant
Save time, effort and money!
No more storage space needed for binders, no more making copies to file in various binders, etc.
Analytics
Analytics is a dashboard that allows departments and investigators to access summary data for their research projects.
Analytics button
Contact Dan