genae
genae buys MedicSense
genae announces the acquisition of MedicSense, a Clinical, Regulatory Affairs and Quality Assurance consultancy firm. MedicSense specializes in developing dedicated regulatory strategies to assist companies in maneuvering through the stringent and dynamic regulation environment.
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.
FDA probes paclitaxel-eluting stents, balloons
The FDA wrote a letter to healthcare providers yesterday on the heels of a meta-analysis that suggested an increased mortality rate after two years in people with peripheral artery disease who were treated with paclitaxel-coated and paclitaxel-eluting devices compared to bare devices.
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
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