Data Management

Guardian EDC™

Guardian EDC™, a web-based, proprietary EDC developed in-house by ACORN CRO, enhances study efficiencies for both industry sponsors and participating sites. Both treatment and non-treatment accrual studies have relied upon Guardian EDC™ for data management.

Guardian EDC™ places study information at the fingertips of users in one centralized location and provides the ability to drill down to minute detail - all in a matter of seconds. User-friendly, intuitive navigation results in high user acceptance ratings. Learning curve delays are virtually eliminated.

Another hallmark of Guardian EDC™ is flexibility via study-specific customization. Upon sponsor approval of an annotated CRF, it only takes 6-8 weeks to develop, test, and deploy a study in Guardian EDC™.

Satisfies all applicable FDA Regulations, including 21 CFR, Part 11
'Sponsor role' access allows real-time review of data entry
Designed with site in mind
User-friendly system
Electronic Principal Investigator signatures
Study amendment capabilities
On-screen audit trail capability (provides user identification, date, time and reason for edit)
Auto-generating reports

Query tracking
CRF completion status
Patient status
Continuing Review

Customized validations (at the point of entry)
Randomization capabilities