genae
The medical device CRO
genae is dedicated to medical devices. We are your partner for an impeccable journey through all clinical trial phases. We will help you in obtaining predictable outcomes, on time, and on budget.
Clinical Trial Management
If you are looking for an expert partner to manage your clinical trial, we’re at your service. As a full-service CRO we support you on all levels and in every step of your clinical research project.
Regulatory & Safety
Stay on top of the ever changing regulatory landscape. genae provides a full range of regulatory support services for your pre- and post-marketing medical device development needs.
Digital Health
Make sure the quality, consistency and completeness of your data is immaculate and exact. genae provides high-quality Digital Health services including data management, statistical analysis of clinical trial data and electronic data tools.
Here’s how FDA officials think you can legally promote off-label device, drug uses
The FDA has issued final guidance clarifying what it considers permissible off-label information for device makers and drug companies to convey to potential customers.
What I appreciate the most about genae is the consistent level of quality they produce. Our medical device study team is knowledgeable, capable and experienced; flexible with our changing needs, and very responsive to our concerns.
— Sara Vidmar, Vice President Clinical & Regulatory Affairs, Mitralign Inc., USA
How can we help you?
Want to hear more about our services or how we can support your clinical trial? Feel free to contact us with any questions you may have.
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