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

Committed to your clinical trial

Through years of experience, genae gained specific expertise in the domain of medical device clinical trials. Our mission is to improve health and quality of life by innovating and accelerating high quality research - with a clear commitment to safety and ethics.

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.

e-Solutions

Make sure the quality, consistency and completeness of your data is immaculate and exact. genae provides high-quality e-solutions including data management, statistical analysis of clinical trial data and electronic data tools.

Latest posts

FDA Issues Guidance on Informed Consent Waivers for Minimal Risk Studies

The US Food and Drug Administration (FDA) on Monday issued a final guidance detailing the circumstances in which the agency will not object to waiving or altering informed consent requirements for clinical studies that pose a minimal risk to participants.

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