Xceltrials™ – Clinical Evidence & CTMS Platform
Xceltrials™ is Bioexcel’s clinical evidence and trial management platform designed specifically for medical device and IVD clinical workflows.The platform supports structured execution and documentation of clinical investigations, PMCF studies,and real‑world data collection, ensuring audit‑ready evidence management.
Capabilities
- Study and site management
- Document version control and traceability
- Monitoring and deviation tracking
- Clinical data capture and organization
- Evidence mapping for CER, PER, and PMCF
- Audit‑ready reporting structure
Regulatory
- ISO 14155 clinical investigations
- EU MDR clinical evidence requirements
- IVDR performance evaluation support
Frequently Asked Questions (FAQ)
Answer :- No. These platforms support regulatory workflows but do not replace regulatory responsibility or authority
decisions.
Answer:- Yes. Platforms can be used as standalone tools or integrated with Bioexcel’s clinical and regulatory services.
Answer : – They support structured data and documentation; final regulatory reports are reviewed and approved by
manufacturers.
