Medical Device Expertise To Guide Your Trial To Success
As a specialty CRO, we concentrate on the unique needs of medical device and diagnostics companies. Since 2005 we’ve utilized our global reach and clinical expertise to guide device and diagnostic companies from regulatory planning and assessments to post-marketing and commercial strategies.
We specifically designed our medical device teams to collaborate with you and address your requirements. Our flexible trial design and customizable teams are built around your infrastructure, functional needs, study design, development phase (preclinical through post-approval) and your therapeutic concentration. While our clinical experience is all-inclusive, our therapeutic concentrations for device and diagnostics include cardio/vascular, orthopedic, CNS/neurology and general surgery.
Helping you reach your goal is our mission.
The Novella Difference
- Preferred vendor status with multiple medical device companies due to our operational execution, quality management program and superior client satisfaction ratings
- In 2004, Novella achieved ISO 9001:2008 certification, a global standard for quality management, and was recertified in 2008 and 2013
- Collaborative, customized project teams with device-specific expertise
- Timely, accurate and transparent communications utilizing eClinical tools (i.e. EDC, CTMS, eTMF, Safety)
- Strong investigator relationships with extensive database capturing site-specific performance metrics and operational details in regions including the US, Europe and Asia Pacific
- Global footprint and infrastructure, with the attention of a dedicated executive on every trial