Clinical Trial Support
End-to-end clinical research services
We offer comprehensive clinical trial support, including IDE preparation,
clinical study design, recruitment, monitoring, data analysis, and post-market surveillance.
Our team ensures that every step aligns with regulatory requirements and scientific
standards.
Our Support Includes:
- IDE (Investigational Device Exemption) Preparation:
Support in the
preparation and submission of IDE applications to the FDA.
- Study Design & Protocol Development: Designing clinical
trials that
meet regulatory and scientific standards.
- Recruitment & Site Management: Ensuring successful
participant
recruitment and site management for clinical trials.
- Data Analysis & Reporting: Rigorous analysis and
reporting of clinical
trial data to support regulatory submissions.
- Post-market Surveillance: Ongoing monitoring and
reporting of device
performance once on the market.