MCR has a consolidated experience and expertise to plan, coordinate and publish research trials involving
medical devices. MCR staff also has experience in phase I-IV clinical trials and no-profit studies
- TRIAL DESIGN
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 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
Organization of Investigator Meetings
Organization of study files for Investigators
Monthly Reports and Newsletters
- REGULATORY ASSISTANCE
Ministry of Health and
Ethics Committees submission
- SITE MANAGEMENT
Site selection visits
Site initiation visits
Close Up visits
- DATA MANAGEMENT and STATISTICS
Perform Single Data Entry
Perform Double Data Entry
Data Monitoring and Auditing
Sample size calculation
Interim and Final Statistical Analysis
- CORE LAB
Quantitative Coronary Angiography Analysis
Final manuscript publication