The genae
genae’s expertise covers a broad range of therapeutic areas. The knowledge and understanding of the specific area of your therapy or device ensures compliance and facilitates in the actual conduct of your trial.
Your advantage of working with genae is captured in our extensive experience in the central coordination and logistics of clinical research projects.
genae’s mission is to improve health and quality of life by innovating and accelerating high quality research – with a zealous dedication to safety and ethics.
With local anchoring, we aim at accelerating high-quality and cost-contained recruitment and execution of your global medical device trials.
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genae updates  


genae session - The impact of the new MDR on clinical affairs - Zurich

22 June 2017

On Thursday June 22, genae is organizing a session which will provide insight to the essential changes of the new Medical Device Regulation (MDR) and the decisions your organization might face. During this interactive afternoon we will discuss among others:
-Key changes and business implications
-Impact on the clinical strategy
-Clinical evaluation and CER

Zuzanna Kwade is Sr. Clinical Safety Manager at genae and acts as an intermediary between different parties involved, incl. event committees, authorities & manufacturers.

Mieke Roelants is Sr. Regulatory Affairs Manager at genae and is involved in all regulatory-related activities incl. submissions, reimbursement & CE-marking projects.

Practical information
DATE: Thursday, June 22, 2017

1.30-2.00 PM: welcome
2.00-4.00 PM: presentation (part I)
4.00-4.30 PM: break
4.30-6.00 PM: presentation (part II)

LOCATION: Holiday Inn Zürich Messe, Wallisellenstrasse 48, 8050 Zürich
The hotel is easily accessible from the airport, the highway and the main station. Please find an overview of all travel options here.


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genae session - Let’s get you ready for your clinical trial - Foster City (CA)

21 June 2017

On Wednesday June 21, genae is organizing a session which will provide insight on the most important steps in designing your clinical trial and increasing the chance of successfully bringing your product to market.

Thelma Bueno is Sr. Clinical Project Manager at genae Americas and has almost 15 years of experience in clinical research and various therapeutic areas. In her current role, Thelma is involved in the project management, study initiation and monitoring activities of medical device trials.

Practical information
DATE: Wednesday, June 21, 2017

8.30-9.00 AM: welcome
9.00-12.00 PM: presentation

LOCATION: Crowne Plaza, 1221 Chess Dr, Foster City, CA 94404
The hotel is easily accessible and has free parking.


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Clinical Regulatory and Safety services

21 April 2017

genae provides a full range of regulatory support services for your pre- and post-marketing medical device development needs. Our experts adopt best practices while remaining on top of the ever-changing regulatory landscape.

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