News

White paper 'Data protection in Clinical Trials - Is Big Brother watching?'

Ensuring proper data protection in a clinical trial is a demanding & expensive process, one that may leave an organization vulnerable to data breaches. It is estimated that as many as 70% of businesses will increase spending in order to become compliant with new data protection laws. This white paper guides you through the most important actions that can be taken to understand and prepare for the new General Data Protection Regulation.

Download your FREE paper on 'Data protection in Clinical Trials - Is Big Brother watching?' here.

Corporate presentation (NEW!)

Download our latest corporate presentation and discover genae's services, products and extensive expertise.

genae session @ LINC 2017

The LEIPZIG INTERVENTIONAL COURSE (LINC) is an interdisciplinary live course, designed to provide a global platform, permitting the discussion of the „vascular patients“ by integrating colleagues of different specialties who are performing endovascular interventions.

We kindly invite you to attend the session 'Clinical trials session - Advancements in clinical research' on Wednesday January 25 in room 6 (11:00-12:30) where genae has the privilege to participate as guest speaker alongside an internationally renowned faculty.

Check out the full programme and speakers here.

Webinar "Optimize your analysis & reduce costs with e-capture.net" recording now available!

Not all electronic data capture systems are the same. When you compare e-capture.net to other EDC platforms, the difference is clear. View our 30 min. webinar to discover all the capabilities you could gain by selecting this comprehensive EDC.

This webinar guides you through the eCRF structure, analysis tools and the various safety workflows.

VIEW NOW!

White Paper 'How to design your Clinical Trial - Solving the puzzle'

Bringing a new medical treatment to market is a challenging process. It is estimated that clinical development programs fail four times out of five. Although a clinical trial can fail for many reasons, poor trial design is often the main cause for failure. A well-planned trial design helps mitigate failure risk and set the trial on a path to success. This paper guides you through the most important steps in successfully designing your clinical trial.

Download your FREE paper on 'How to design your Clinical Trial - Solving the puzzle' here.

Explore the NEW e-capture.net & edc2go websites



Need a comprehensive and secure EDC platform to collect clinical trial data? e-capture.net is fully customizable and allows you to build all the reports you want.

Explore the NEW e-capture.net

edc2go is the Do-It-Yourself EDC platform allowing you to build your own eCRF with ease and collect data in a matter of days instead of weeks or months.

Explore the NEW edc2go.com

edc2go webinar (July 18) - recording available!

The main goal of any EDC solution is to be secure, user friendly and customized to fit your specific trial.

The ed2cgo platform is such an EDC tool with price transparency, is easy to use and a FREE 30day trial.

View this 50 min. webinar and find out how easy it is to build an eCRF with edc2go. Visit edc2go.com for more information.

VIEW THE WEBINAR HERE

genae Americas celebrates its 5th anniversary

genae Americas celebrates its 5th anniversary this year.

Since 2011 we have opened offices in Cleveland, New York City & San Francisco and managed clinical trials together with over 200 sites.

Discover our geographical experience in the US here.

FIRE AND ICE trial published in NEJM

The FIRE AND ICE trial is a multicenter, randomized, noninferiority, parallel-group, open-label trial, with blinded end-point assessment, in which cryoballoon ablation was compared with radiofrequency ablation.

Read the article here.

genae Opens Offices in San Francisco

genae, a global Contract Research Organization (CRO) and service provider for the medical industries, announced today the expansion of its North American activities with the opening of offices in San Francisco. genae Americas was incorporated in 2011 and has since then opened offices in New York City and Cleveland, Ohio.

"San Francisco is strategically centered in one of the highest concentrations of medical innovation and leading research facilities on the West Coast", said Philippe Kassab, President at genae Americas. "The expansion of genae from the East Coast to the West Coast supports our commitment to be closer to our industry partners and patient population, and to deliver high quality clinical research."

As of May 2016, almost 40% of the world's medical devices clinical trials were conducted in North-America, with a third of U.S. medical devices clinical trials on the West Coast.

About the genae  group

genae is involved in the development and commercialization of medical devices, biologics and therapies that change medical practice. genae is a full service CRO and services provider for the medical industries and aims at improving health and quality of life by innovating and accelerating high quality research. The group's Quality Management System has been tested rigorously and continues to pass regulatory and sponsor's audits and inspections.

genae associates nv is a privately held company with principal offices in Antwerp, Belgium and is part of the genae group, the medical device CRO.

To learn more about genae, please visit http://www.genae.com.

Contact
genae associates nv
Bart Segers, CEO
+32-3-290-03-06
Justitiestraat 6B, 2018 Antwerp, Belgium
bart.segers@genae.com

genae Americas, Inc.
Philippe Kassab, President
+1-216-445-4535
10000 Cedar Avenue, Cleveland, OH 44106, USA
philippe.kassab@genae.com


White Paper 'Insourcing or Outsourcing - Do the sums add up?'

Insourcing or outsourcing in clinical trials is a late-breaking topic. Despite other branches of trade such as the automotive industry where large companies are experiencing a comeback of insourcing, the conduct of clinical trials are mostly outsourced to contract research organizations (CROs). This paper tackles the benefits and challenges of both approaches and sheds light on what to take into consideration when outsourcing your clinical trial to a CRO.

Download your FREE paper on 'Insourcing or Outsourcing - Do the sums add up?' here.

genae Appoints Chief Medical Officer

genae, a Contract Research Organization (CRO) and services provider for the medical industries, announced today the appointment of Prof. Dr. Jörn Balzer to the role of Chief Medical Officer. Prof. Balzer's responsibilities will include all clinical, safety and risk management related to genae's research services.

"We feel privileged and honored with the acceptance of Prof. Balzer to join our team," said Bart Segers, CEO at genae. "Prof. Balzer's impressive and extensive background make him a perfect fit for the genae team, as his extensive clinical and research expertise will play a key role in helping us to achieve our goals and strategic priorities."

Prof. Balzer is Head Physician and Medical Director at the Katholische Klinikum Mainz, Germany. Previously, he was Assistant Medical Director at the Klinikum der Johann Wolfgang Goethe Universität in Frankfurt Am Main, Director at the Universitätsklinikum des Saarlandes in Homburg /Saar, and Intern at the Charité Campus Virchow Klinikum in Berlin. His scientific and research work is illustrated by peer-reviewed publications and presentations during international congresses and symposia.

About the genae  group

genae is involved in the development and commercialization of medical devices, biologics and therapies that change medical practice. genae is a full service CRO and services provider for the medical industries and aims at improving health and quality of life by innovating and accelerating high quality research. The group's Quality Management System has been tested rigorously and continues to pass regulatory and sponsor's audits and inspections.

genae associates nv is a privately held company with principal offices in Antwerp, Belgium and is part of the genae group, the medical device CRO.

Korys invests in genae

genae, a global Contract Research Organization (CRO) and services provider for the medical industries, announced the closing of an investment by Korys.

This transaction underlines the commitment of genae's management to accelerate the group's development, now backed by a strong and culturally compatible equity partner.

"With this investment, Korys takes part in a medical device CRO that is capable of providing high-quality research services on a global scale, assisting their partners in bringing new therapies and products to market. We look at genae and its innovative and entrepreneurial team as strong contributors to our 3P (people-planet-profit) vision" said Vincent Vliebergh, Korys' CEO.

"The entrance of Korys accelerates genae's strategy to further strengthen our position as the leading medical device CRO in Europe, while continuing to build critical scale in the US and Japan," said Bart Segers, genae's CEO.

About Korys

Korys is the investment holding of the Colruyt family. The family has been active in the retail sector for over 50 years and grew the Colruyt Group to become one of the most successful food retail and food services companies in Europe. Korys aims to create sustainable value through a diversified portfolio of investments and focuses on sectors in which it has built substantial expertise, such as Consumer and Retail, Renewable Energy and Life Sciences.

To learn more about Korys, please visit http://www.korys.be.

About the genae  group

genae is involved in the development and commercialization of medical devices, biologics and therapies that change medical practice. genae is a full service CRO and services provider for the medical industries and aims at improving health and quality of life by innovating and accelerating high quality research. The group's Quality Management System has been tested rigorously and continues to pass regulatory and sponsor's audits and inspections.

genae associates nv is a privately held company with principal offices in Antwerp, Belgium and is part of the genae group, the medical device CRO.

To learn more about genae, please visit http://www.genae.com.

Contact

Korys
+32-2-318-25-00
Guido Gezellestraat 126
1654 Huizingen
enquiries@korys.be

genae associates nv
Bart Segers, CEO
+32-475-566-780
Justitiestraat 6B, 2018 Antwerp, Belgium
bart.segers@genae.com

genae nominated for Trends Gazellen Ambassador for Antwerp 2016

genae is nominated for the “Trends Gazellen Ambassadors 2016” for the Antwerp Province in the category mid-sized companies.

genae won this prestigious nomination in 2014.

edc2go webinar (Feb 1) - recording available!

Building your eCRF has never been easier
The main goal of any EDC solution is to be secure, user friendly and customized to fit your specific trial.

The ed2cgo platform is such an EDC tool with price transparency, is easy to use and a FREE 30day trial.

View this 50 min. webinar and find out how easy it is to build your eCRF with ease and collect data in hours instead of weeks or months.

VIEW THE WEBINAR HERE

Japanese Company Fact Sheet

Discover our services, extensive experience and interesting facts in our latest Japanese genae fact sheet.

Download this free resource here.

White Paper 'How data integration can transform clinical research’

The pharmaceutical and medical device industries continuously look for opportunities to effectively and efficiently manage data collected in clinical trials to deliver meaningful treatments to those in need. This document guides you through the biggest trends in data integration that reduce overall trial cost and accelerate the flow of critical information to key stakeholders.

Download your FREE paper on 'How data integration can transform clinical research’ here.

INTEGR8 publication

genae initiated the INTEGR8 study to demonstrate the integration of a wearable device in an EDC. This publication highlights the key successes of the study: 2-way communication between wearable and EDC, as well as data correlation.

Download a free copy of our INTEGR8 publication or discover all study details in our Innovation page.

genae opens offices in Tokyo

genae, a global Contract Research Organization (CRO) and services provider for the medical industries, announced today the incorporation of genae Japan in Tokyo.

Japan has the second largest healthcare market in the world. Market growth factors include the rise of chronic diseases, an aging population and the increase of home-based care as a result. Globally, Japan has the highest percentage of citizens over the age of 65 - a figure that is also growing more rapidly than in western nations.

Asia’s increasing economic development drives a new medical device industry, particularly in Japan, China, Vietnam, and Malaysia. The Southeast Asian medical device market is expected to grow to $10 billion by 2020.

The rapidly expanding markets in Asia also fuel continuous regulatory changes that focus on streamlining and optimizing testing and monitoring processes worldwide. Rigorous long-term monitoring and reporting of adverse effects is required after the device becomes available on the market.

“The incorporation of genae Japan, with HQ in Tokyo, illustrates our commitment and ability to provide high quality research services on a global scale”, said Bart Segers, genae’s CEO. “The Greater Tokyo Area is a vast economic region that supports a population of 36 million people. Tokyo boasts a wealth of capable individuals and companies with excellent technologies.”


About the genae group

genae is involved in the development and commercialization of medical devices, biologics and therapies that change medical practice. As a full service CRO and services provider for the medical industries, genae aims at improving health and quality of life by innovating and accelerating high quality research. genae's Quality Management System is ISO 9001 compliant, has been tested rigorously and continues to pass regulatory and sponsor’s audits and inspections.

genae associates nv is a privately held company with principal offices in Antwerp, Belgium and is part of the genae group, the medical device CRO.

To learn more about genae, please visit www.genae.com.


Contact

genae associates nv
Bart Segers, CEO
+32 475 566 780
Justitiestraat 6B, 2018 Antwerp, Belgium
bart.segers@genae.com

genae INTEGR8 study embeds wearables in digital health data workflow

genae, a global Contract Research Organization (CRO) and services provider for the medical device industry, has completed enrollment for the INTEGR8 study, a program to demonstrate and validate the integration of a wearable device (Microsoft Band, Microsoft) in an electronic data capture workflow (edc2go, genae).

For the duration of one month, the INTEGR8 study enrolled 19 subjects across  4 countries who answered quality of life questions via a wearable device. The questions were sent from edc2go, a disruptive Electronic Data Capture (EDC) platform, to the subjects. The answers were transmitted to a smart phone via a Bluetooth connection and from there over an encrypted 3G/Wi-Fi connection to edc2go for storage and processing. 

"This is an important step towards reducing costs by limiting follow-up visits, simplifying the clinical study and routine follow-up workflow, and enabling real-time assessment of the patient’s safety. " said Bart Segers, CEO of genae. “Although the technology is in an early phase, it is very promising and attracts a lot of attention from the stakeholders in the digital health data industries.”

“From an investigator’s perspective, the integration of this wearable technology in data collection workflows may have a positive impact on patient compliance and medical costs”, commented Dr. Stefan Verheye. “Adherence to medication schedules, QOL indicators and pain scores are metrics that are captured today during telephone calls or follow-up visits. This technology may truly enable remote monitoring and ultimately improve patient outcome”.

The results of the novel INTEGR8 study and technology will be published later this year.  For further information, please visit www.genae.com.


About the genae group

genae is involved in the development and commercialization of medical devices, biologics and therapies that change medical practice. As a full service CRO and innovative services provider for the medical industries, genae aims at improving health and quality of life by innovating and accelerating high quality research. genae's Quality Management System is ISO 9001 compliant, has been tested rigorously and continues to pass regulatory and sponsor’s audits and inspections.

genae associates nv is a privately held company with principal offices in Antwerp, Belgium and is part of the genae group, the medical device CRO.


Contact

genae associates nv
Bart Segers, CEO
+32 475 566 780
www.genae.com
bart.segers@genae.com

genae buys e-novex

genae, a global Contract Research Organization (CRO) and services provider for the medical industries, announced today the acquisition of e-novex, a leading provider of electronic data tools that change medical research.

e-novex' proprietary Electronic Data Capture (EDC) technology is widely adopted by pharmaceutical, biotech and medical device companies, CRO's, Academic Research Organizations (ARO) and individual researchers. The portfolio comprises of e-capture.net for approval studies and the disruptive technology edc2go which allows building an electronic Case Report Form (eCRF) in a matter of hours instead of weeks or months. The core lab tracker platform facilitates the management and tracking of image logistics and enables secure transfer of large image data sets.

"The purchase of e-novex further increases genae's capacity to provide electronic solutions to our customers in the medical industries. The acquisition is also expected to result in greater eHealth efficiencies and in significantly increasing our capabilities in data management and risk based monitoring," said Bart Segers, CEO of genae.

The entire e-novex staff will be integrated in genae's e-Solutions business unit that already includes data management and statistics efficiencies. There will be no disruptions of e-novex' services during the integration which will take place over the next three months.

For further information, please visit http://www.genae.com and http://www.e-novex.com.

About the genae group

genae is involved in the development and commercialization of medical devices, biologics and therapies that change medical practice. As a full service CRO and innovative services provider for the medical industries, genae aims at improving health and quality of life by innovating and accelerating high quality research. The group is ISO 9001 certified for clinical trial management, data management, statistical analysis, safety, regulatory, core laboratory and medical writing services for the medical industries.

genae associates nv is a privately held company with principal offices in Antwerp, Belgium and is part of the genae group, the medical device CRO.

Contact
genae associates nv
Bart Segers, CEO
+32-475-566-780
Justitiestraat 6B, 2018 Antwerp, Belgium
bart.segers@genae.com

genae opens offices in New York City

genae, a global Contract Research Organization (CRO) and service provider for the medical industries, announced today the expansion of its North American activities with the opening of offices in New York City. genae Americas was incorporated in 2011.

"New York City is strategically centered in one of the highest concentrations of medical innovation and leading research facilities on the East Coast", said Philippe Kassab, President at genae Americas. "The expansion of genae from Cleveland, Ohio to the East Coast supports our commitment to be closer to our industry partners and patient population, and to deliver high quality clinical research."

In September 2014, just over 40% of the world's medical devices clinical trials were conducted in the United States with a majority on the East Coast, in California and in Texas.

About genae

genae is involved in the development and commercialization of medical devices, biologics and therapies that change medical practice.

genae is a global, full service CRO, aiming at improving health and quality of life by innovating and accelerating high quality research. The group is ISO 9001 certified for clinical trial management, data management, statistics, safety and regulatory services for the medical industries.

genae associates nv is a privately held company with principal offices in Antwerp, Belgium and is part of the genae group, the medical device CRO.

To learn more about genae, please click here

genae opens offices in Dubai and announces collaboration with leading Gulf clinicians

genae, a global Contract Research Organization (CRO) and services provider for the medical industries, announced today the incorporation of genae Gulf in Dubai, and the joint effort with leading clinicians from the region, including cardiologist Dr. Ibrahim Al Rashdan.

"There is an exponentially growing demand for combining efforts between the Gulf region and the West, in terms of high quality but cost-conscious clinical research", said Dr. Al Rashdan. "It combines the vision and guidance on evidence based medicine of our group in the Middle East with the proven CRO model of genae in the Americas and Europe."

Dr. Al Rashdan was involved in numerous cardiovascular clinical trials as Principal Investigator and serves as Course Director of the Gulf PCR congress.

"By combining our mutual expertise in health care and clinical research, in symphony with local culture and regulations, this collaboration is truly about building bridges in the pursuit of advancing sponsored clinical trials", said Bart Segers, CEO at genae.

Dubai is an icon of entrepreneurship and modernity in the Arab world. As the second largest emirate behind Abu Dhabi, the capital of the UAE, Dubai is globally recognized as the Middle East region's international business hub. Since 2000 real GDP of Dubai has been growing at a CAGR of about 15%. In 2009, 95% of Dubai's GDP came from non-oil sectors, a unique differentiator in a region where economies are dependent on oil incomes. The metropolis is offering outstanding infrastructure, a state-of-the-art telecommunications network and unparalleled connectivity.

About genae

genae is involved in the development and commercialization of medical devices, biologics and therapies that change medical practice.

genae is a full service CRO and an innovative services provider for the medical industries and aims at improving health and quality of life by innovating and accelerating high quality research. The group is ISO 9001 certified for clinical trial management, data management, statistical analysis, safety, regulatory, core laboratory and medical writing services for the medical industries.

genae associates nv is a privately held company with principal offices in Antwerp, Belgium and is part of the genae group, the medical device CRO.

To learn more about genae, please visit http://www.genae.com

genae Opens Offices in London

genae, a global Contract Research Organization (CRO) and services provider for the medical industries, announced today the incorporation of genae UK in London.

The United Kingdom has one of the largest medical device markets in the world. It was valued at USD 8.9 billion in 2012 and it is projected to increase by a CAGR of 6.0% until 2017. Health expenditure was estimated at USD 234 billion in 2012, equal to 9.5% of GDP. Despite recessionary pressures, market growth rates over the coming years will be positive.

"The mature and high value medical device market in Western Europe is wealthy and developed. The friction between attempts to contain health costs and a desire to remain at the forefront of technological innovation leads to an increased demand for efficiencies. For example: medical devices that facilitate minimally invasive therapies to ensure a faster turnaround of patients." said Bart Segers, CEO at genae. "The incorporation of genae UK is a logical step in our commitment to provide high quality research services on a global scale."

London is a leading global city with many strengths that contribute to its prominence. It is one of the world's leading financial centers and its universities form the largest concentration of higher education in Europe. London has a diverse range of people and cultures and has one of the largest city airport and transportation systems, measured by passenger traffic.

About genae

genae is involved in the development and commercialization of medical devices, biologics and therapies that change medical practice.

genae is a full service CRO and an innovative services provider for the medical industries and aims at improving health and quality of life by innovating and accelerating high quality research. The group is ISO 9001 certified for clinical trial management, data management, statistical analysis, safety, regulatory, core laboratory and medical writing services for the medical industries.

genae associates nv is a privately held company with principal offices in Antwerp, Belgium and is part of the genae group, the medical device CRO.

To learn more about genae, please visit http://www.genae.com.

Contact
genae associates nv
Bart Segers, CEO
+32-3-290-03-06
bart.segers@genae.com

genae UK Limited
20-22 Bedford Row
London WC1R 4JS, UK

genae Trends Gazellen Ambassador for Antwerp

genae Trends Gazellen Ambassador for Antwerp

genae opens offices in Warsaw

genae, a global Contract Research Organization (CRO) and services provider for the medical industries, today announced the incorporation of genae Poland in Warsaw.

"Poland is the most populated country in Central and Eastern Europe (CEE) and features qualified and experienced researchers and supportive medical staff. This gives it strong potential for increased patient recruitment while maintaining high quality of data at a competitive cost." said Bart Segers, CEO at genae. "The offices in Warsaw further enhance our commitment to offering a global CRO reach by implementing local anchoring".

Warsaw is the largest financial and economic hub of CEE. The city is Poland's top academic center and the most important destination for R&D in the country. Its young, motivated and highly skilled workforce has international experience as well as strong foreign-language skills. Two airports, Chopin and Modlin, connect Warsaw to the rest of Europe and the world.

About genae

genae is involved in the development and commercialization of medical devices, biologics and therapies that change medical practice.

genae is a full service CRO and an innovative services provider for the medical industries and aims at improving health and quality of life by innovating and accelerating high quality research. The group is ISO 9001 certified for clinical trial management, data management, statistical analysis, safety, regulatory, core laboratory and medical writing services for the medical industries.

genae associates nv is a privately held company with principal offices in Antwerp, Belgium and is part of the genae group, the medical device CRO.

To learn more about genae, please visit http://www.genae.com.

Contact: Bart Segers, CEO, bart.segers@genae.com, +32-3-290-03-06 (office)

genae opens offices in Frankfurt

genae, a global Contract Research Organization (CRO) and services provider for the medical industries, today announced the incorporation of genae Germany GmbH in Frankfurt am Main.

Today, 480 concurrent medical device trials are being conducted in Germany, which accounts for almost 20% of all medical device trials in Europe.

"The German offices will create 12 to 15 new jobs in the next three years," said Bart Segers, CEO at genae. "We continue to expand our operations in Europe and beyond to serve our customers better by providing local anchoring and cultural compatibility, while maintaining a global focus on research."

Frankfurt is a major air, rail and highway transportation hub due to its central location within Germany and Europe. Frankfurt Airport is one of the world's busiest international airports and Frankfurt Central Station is one of the largest terminal stations in Europe.

About genae

genae is involved in the development and commercialization of medical devices, biologics and therapies that change medical practice.

genae is a full service CRO and an innovative services provider for the medical industries and aims at improving health and quality of life by innovating and accelerating high quality research. The group is ISO 9001 certified for clinical trial management, data management, statistical analysis, safety, regulatory, core laboratory and medical writing services for the medical industries.

genae associates nv is a privately held company with principal offices in Antwerp, Belgium.

Please visit: http://www.genae.com

Contact

genae associates nv, Justitiestraat 6B, 2018 Antwerp, Belgium
genae Germany GmbH, Schumannstrasse 27, 60325 Frankfurt am Main, Germany
genae International AG, Europaallee 41, 8021 Zürich, Switzerland
genae Americas, Inc., GCIC, 10000 Cedar Avenue, Cleveland, OH 44106, USA

genae opens offices in Switzerland

genae, a global Contract Research Organization (CRO) and services provider for the medical devices industries, today announced the incorporation of genae International AG.

The centrally located Swiss services facility will support the group's expanding operations and forms the second base in Europe.

"The Swiss offices reflect the growing demand of our strategic partners to provide local presence and tailored support," said Bart Segers, CEO at genae. "With local anchoring, we aim at accelerating high-quality and cost-contained recruitment and execution of our medical device trials in Switzerland and other European countries."

About genae

genae is involved in the development and commercialization of medical devices, biologics and therapies that change medical practice.

genae is a full service CRO and an innovative services provider for the medical industries and aims at improving health and quality of life by innovating and accelerating high quality research. The group is ISO 9001 certified for clinical trial management, data management, statistical analysis, safety, regulatory, core laboratory and medical writing services for the medical industries.

genae associates nv is a privately held company with principal offices in Antwerp, Belgium.

Please visit: http://www.genae.com

Contact

genae associates nv, Justitiestraat 6B, 2018 Antwerp, Belgium

genae International AG, Europaallee 41, 8021 Zürich, Switzerland

genae Americas, Inc., GCIC, 10000 Cedar Avenue, Cleveland, OH 44106, USA

Bart Segers, CEO
bart.segers@genae.com
+32-3-290-03-06
 

Yale signs Collaborative Agreement with genae

Yale University, Yale Cardiovascular Research Group (YCRG), a world-renowned Academic Research Organization (ARO) and genae associates nv, a global Contract Research Organization (CRO) and services provider for the medical device industries today announced they have signed a collaboration and co-marketing agreement.

YCRG and genae will formalize various platforms to facilitate collaboration including cross-marketing and referral of services to each other, co-facilitation of liaison with regulatory and governmental bodies and co-deployment of staff, facilities and other resources.

The collaboration will enable expanding the ARO and CRO services across the value chain of research from pre-clinical to clinical evaluation and beyond. YCRG and genae will increase market reach by sharing and sub-contracting monitoring, regulatory, safety, core laboratory, data management and statistical analysis services.

YCRG Director Dr. Alexandra Lansky has served as the principal investigator for numerous trials investigating novel cardiovascular devices and adjunctive pharmacology, and has led the core laboratory analysis of more than 500 clinical trials.

"The growing demand for high-quality but cost-conscious clinical research faces technological, economic and regulatory change", said Dr. Lansky. "This unique ARO/CRO collaboration takes advantage of the opportunities of sponsored clinical trials to advance scientific understanding and to promote a broad application of evidence-based medicine that will ultimately benefit patients. It combines the need for academic vision and guidance with the need for partners that have an entrepreneurial approach, scalable capabilities and financial backing to invest for the future."

"I am absolutely thrilled about this collaboration. Cultural alignment and understanding each other's expectations to ensure agreement on processes and metrics are the brick and mortar of true partnerships with our medical industry partners", said Bart Segers, CEO at genae. "This ARO/CRO governance model guides the relationship from a strategic and operational point and helps to build long-term, trust-based relationships at multiple levels across the organizations."

About Yale Cardiovascular Research Group

The Yale Cardiovascular Research Group (YCRG) is an ARO that provides independent resources for the conduct of cardiovascular clinical trials and clinical evaluation/scientific program development activities. YCRG serves as a regulatory interface and provides comprehensive clinical trial development and management services. Clinical research and device development experience includes First-In-Human, regulatory CE Mark and IDE/IND phase II and III trials, and post market and investigator-initiated clinical programs. The YCRG core laboratory provides state-of-the art imaging interpretation and endpoint measures in multiple modalities.

Yale University is a nonprofit corporation organized and existing under and by virtue of a special charter granted by the General Assembly of the Colony and State of Connecticut.

Please visit: http://cardio.med.yale.edu/clinicalresearch

About genae

genae is involved in the development and commercialization of medical devices, biologics and therapies that change medical practice.

genae is a full service CRO and an innovative services provider for the medical industries and aims at improving health and quality of life by innovating and accelerating high quality research. The group is ISO 9001 certified for clinical trial management, data management, statistical analysis, safety, regulatory, core laboratory and medical writing services for the medical industries.

genae associates nv is a privately held company with principal offices in Antwerp, Belgium.

Please visit: http://www.genae.com


Contact

Yale Cardiovascular Research Group
1 Church Street, Suite 330
New Haven, CT 06510, USA
Alexandra Lansky, MD
Director, Interventional Cardiovascular Research
alexandra.lansky@yale.edu


genae associates nv
Justitiestraat 6B
2018 Antwerp, Belgium
Bart Segers
CEO
bart.segers@genae.com
+32-3-290-03-06

Standardized Definitions and Clinical Endpoints

Objectives

Endovascular therapy is a rapidly expanding option for the treatment of patients with aortic dissection (AD) and various studies have been published. These trials, however, are often difficult to interpret and compare because they do not utilize uniform clinical endpoint definitions.

Methods

The DEFINE Group is a collaborative effort of an ad hoc multidisciplinary team from various specialties involved in AD therapy in Europe and the United States. DEFINE's goal was to arrive at a broad based consensus for baseline and endpoint definitions in trials for endovascular therapy of various vascular pathologies. In this project, which started in December 2006, the individual team members reviewed the existing pertinent literature. Following this, a series of telephone conferences and face-to-face meetings were held to agree upon definitions. Input was also obtained from regulatory (United States Food and Drug Administration) and industry (device manufacturers with an interest in peripheral endovascular revascularization) stakeholders, respectively.

Results

These efforts resulted in the present document containing proposed baseline and endpoint definitions for clinical and morphological outcomes. Although the consensus has inevitably included certain arbitrary consensus choices and compromises, adherence to these proposed standard definitions would provide consistency across future trials, thereby facilitating evaluation of clinical effectiveness and safety of various endovascular revascularization techniques.

Conclusions

This current document is based on a broad based consensus involving relevant stakeholders from the medical community, industry and regulatory bodies. It is proposed that the consensus document may have value for study design of future clinical trials in endovascular AD therapy as well as for regulatory purposes.