- TRIAL DESIGN
Protocol Development
Protocol Review
Case Report Form Preparation
Case Report Form Review
- IDAS E-CRF
Compliance with FDA 21 CFR part 11.
Compatible with main web browsers
(IE, Firefox, Chrome, Safari and Opera).
On-line randomization.
On-line control of data plausibility and consistency.
Automatic query generation.
Graphic reports and descriptive statistics.
Audit Trail: tracking all user operations.
Secure transmission using SSL 256-bit encryption.
Hosting server in a secure web farm under 7x24 monitoring.
Redundant hardware and backup.
- CENTRAL COORDINATION
Project Management
Centers Recruitment
Organization of Investigator Meetings
Organization of study files for Investigators
Monthly Reports and Newsletters
Study Committees
- REGULATORY ASSISTANCE
Ministry of Health and
Ethics Committees submission
Safety Reporting
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- SITE MANAGEMENT
Feasibility
Site selection visits
Site initiation visits
Site Monitoring
Close Up visits
- DATA MANAGEMENT and STATISTICS
Design Database
Perform Single Data Entry
Perform Double Data Entry
Data Monitoring and Auditing
Queries Generation
Database lock
Randomization list
Sample size calculation
Interim and Final Statistical Analysis
- CORE LAB
Quantitative Coronary Angiography Analysis
IVUS Analysis
ECG Analysis
- REPORTING
Final Report
Statistical Report
Final manuscript publication
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