Clinical Trial Management Services
Libra Medical is a full service Clinical Data Management and Clinical Trial Data Management Organization offering services for phase I-IV clinical trials, post market studies, e-registries, and investigator-initiated grants management programs conducted by biotech, pharmaceutical, and medical device companies including academic medical centers. Libra Medical has experience running clinical trials in the US, Canada, Mexico, Western Europe, India, and Australia.
We deliver a completely integrated, configurable clinical research platform for studies of all sizes. Easy to learn and use, your study can be up and running in just a few weeks.
Services provided:
- Clinical Strategy
- Protocol Development
- Case Report Form (CRF) Design
- Informed Consent
- Regulatory Binders
- Clinical Study Aids
Clinical Research
- Site Initiation Visit
- Clinical Monitoring
- Timely and Thorough Monitoring Reports
- Site Close-out Visits
Site Qualification and Monitoring
- Sample Size and Power Calculation
- Statistical Analysis Plan
- Statistical Analysis
Statistical Services
- Database Design, Validation and Maintenance
- Data Management
- Paper CRF or EDC Management
- 21 CFR Part 11 Compliant
- Safety Monitoring
- Data Monitoring Committee (DMC) management
- Clinical Events Committe (CEC)Management
- Study Reports
Data Management
- IRB Approvals
- Device/Product Tracking
- Payments
- Document Management
- Randomization
- Contract Negotiation
- Regulatory and Patient Binders
- Master Study File Maintenance
- Site Correspondence
- Site Training