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 Invests in Meditrix

30 May 2017

genae, a global Contract Research Organization (CRO) and service provider for the medical industries, announced the closing of an investment in Meditrix. The clinical research group further obtained a call option to acquire all remaining shares of Meditrix.

The global market for medical device technologies is expected to reach USD 642 billion by the end of 2020, and Japan is one of the largest markets in this domain, behind the US and Europe.

"While Japan represents a key market for the medical industries, it is a complex system for foreign med-tech companies to penetrate" said Bart Segers, genae's CEO. "Having a clear understanding of the regulatory and market hurdles is critical to decrease time and cost to market, and to avoid hazardous strategies for our customers".

"Medical therapeutics and the medical device industries in Japan will benefit from the strategic partnership between genae and Meditrix," according to Ichiro Oshiba, President of Meditrix. "This collaboration will accelerate the much-required adoption of sophisticated medical technologies that are being developed outside Japan", he continued. "In addition, it presents a unique window for the promotion of the Japanese medtech industries".

With this investment, genae further expands its activities in Japan and in the Asia Pacific region.

About the genae group
genae is involved in the development and commercialization of medical devices that change medical practice. genae is a full service CRO and service provider for the medical industries and aims at improving health and quality of life by innovating and accelerating high quality research. With HQ in Antwerp, Belgium, genae operates from 11 offices in 9 countries and serves a client base ranging from publicly traded, strategic players to very early start-ups.
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About Meditrix
Meditrix is a full service CRO with focus on clinical studies of medical devices in pre- and post-marketing stage in Japan. In such activities, Meditrix is contributing to collecting clinical data by utilizing its well-trained resources and its proprietary Electronic Data Capture system, tailored for the Japanese market. Meditrix operates from its HQ in Tokyo and from branch offices in Osaka and Fukuoka.
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genae associates nv
Bart Segers, CEO
+32 3 290 03 06
Justitiestraat 6B, 2018 Antwerp, Belgium

Meditrix Co., Ltd.
Ichiro Oshiba, President
+81 3  6261 5111
1-5-15 Hirakawa-cho, Chiyoda-ku, Tokyo, Japan

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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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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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