You need to move fast, but the path from device development to market access is riddled with complexity. Many IVD developers commonly express the need for a single-source solution that brings in expertise when they need it.
MDC meets this need by offering an integrated clinical, regulatory, and quality team dedicated to quickly standing up and managing clinical studies – turning clinical data into compliant, market-ready submissions.
Types of Studies Supported:
✓ Sample Collection
✓ Pre-Clinical / Proof-of-Concept
✓ Clinical Validation
✓ Reproducibility
✓ Analytical
✓ CLIA-Waiver
✓ Formative & Summative Usability
✓ Post-Market / Health Economic & Outcome
Shraddha Dubal
Director, CRO Services
“Driven by a passion for clinical research, our team combines strategic insight with flawless execution to deliver exceptional results for your studies. We’re ready to get to work.”
Planning & Setup
- Site identification and qualification
- Study documentation
- Contracting and IRB
- Budget planning and project management
Study Management
- Site visits and monitoring
- Real-time data management and analysis
- Quality assurance / auditing
- Trial Master File management
Closeout & Reporting
- Site closeout
- Database lock
- Report delivery
Core Solutions
WE ARE SPECIALISTS
CLINICAL SERVICES
REGULATORY SERVICES
With you from strategy through submission.
QUALITY SERVICES
Quality system planning, audit support and remediation.