Our clinical trial solution is the end to end Clinical Trial Management (CTM) platform which can manage all the clinical trial from phases I to phases IV, It is a single platform which allows a Contract Research Organization,Pharmaceutical and Biotech industriesto plan, manage, design, execute, monitor and analyze trial related activities and data requirement as per protocol obligations and regulatory requirements. It’s a single solution that manage Early Phase,Late Phase, Oncology Trials and Post Approval Trials.
Capability
- Biometric/Iris based Registration & Screening
- Data management and archival
- Data export to PDF, EXCEL and CDISC formats
- Project progress tracking
- Intuitive eCRF and EDC designing tools
- Multi-level electronic review procedure
- Medical coding from standard dictionaries like MedDRA, WHODD
- Manage various projects such as BA-BE and Clinical Trial
- Track multi-centric and multi-period projects
- Auto-schedule and slot of activities
- Email alerts for activities
- Machine integration
CFR part 11 compliance;
- Audit trail
- Rights/Roles specific system
- Work flow management
- Pass many Audits of USFDA, MHRA etc
- As per GxP, GcP standard
