Clinical IT Solutions
Integrated technology platforms and digital solutions for clinical trial execution and management.
Electronic Case Report Form (eCRF)
- Form design:
Custom eCRF development and validation rule configuration - Data entry optimization:
User-friendly interfaces and real-time validation - Integration capabilities:
Seamless connectivity with clinical databases - Compliance features:
21 CFR Part 11 validation and audit trail management
- Form design:
Electronic Trial Master File (eTMF)
- Document repository:
Centralized storage and version control systems - Regulatory readiness:
Inspection-ready documentation and compliance tracking - Access management:
Role-based permissions and secure document sharing
- Document repository:
Electronic Investigator Site File (eISF)
- Site documentation:
Digital organization of essential site documents - Real-time updates:
Automatic synchronization with central systems - Compliance tracking:
Document completeness and regulatory requirement monitoring - Collaboration tools:
Secure communication between sites and sponsors
- Site documentation:
Electronic Patient Reported Outcome (ePRO, e-Diary)
- Mobile platforms:
Patient-friendly apps and web-based interfaces - Data collection:
Real-time patient-reported outcomes and diary entries - Compliance monitoring:
Medication adherence tracking and reminder systems - Data integration:
Seamless transfer to clinical databases and analysis platforms
- Mobile platforms:
Clinical Trials Management System (CTMS)
- Study oversight:
Timeline management and milestone tracking - Resource coordination:
Site management and investigator communication - Monitoring activities:
Visit planning, report generation, action items tracking, and issues/deviation management - Performance analytics:
Enrollment metrics and operational dashboards
- Study oversight:
