Working with a competent clinical study site to perform an IVD clinical trial is a key factor for trial success and outcomes. Although IVD clinical studies share several commonalities with medical device trials, there are many differences and nuances that must be considered prior to selection of an adequate study site.
Join NAMSA for this upcoming webinar to explore the key differences between medical device and IVD clinical trials, and learn the key elements that should be explored and identified before finalizing study site(s) selection.
Webinar participants will leave with a better understanding of:
- Different site qualifications and selection processes for IVD and medical device trials
- Contracting, budgeting and cost considerations
- Lab certifications (CLIA, CAP)
- Principal Investigator and study staff qualifications and proficiencies (Good Clinical Practice and Regulatory Requirements)
- Methods of recruiting and accessing the desired study population
- How to assess competing and conflicting studies with the same targeted population
- On-site and remote monitoring
Time will also be allotted for Q&A.