With you,
for you

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.

Discover our expertise

Let's Get you Ready for your Clinical Trial | Webinar | 28 March 2018

Whether you are a first-time inventor or a large manufacturer, the thrill of bringing a medical device to market is both exhilarating and overwhelming. ​​​​​​​Join our 30 min. webinar to gain insight on the most important steps in designing your clinical trial and increasing your chances of successfully launching your product.

Read more here

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.

Read more

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.

Read more

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.

Read more

Latest posts

FDA Expert Panel Considers Trial Designs for Neurological Devices

Most members of the FDA’s Medical Devices Advisory Committee panel on neurological devices said age should not be a consideration for inclusion in a clinical trial, but life expectancy should, and patients with less than one year of life expectancy should be excluded from studies.

Read more

Sara Vidmar

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.

Contact us