Download 25404 Medifacts Insert

Clinical Research Services
Fusing science, service, and technology.
Your Goal
NDA, PMA, or market penetration/increase sales
Solutions That Work
❑ Our experienced cardiovascular development team includes experts in protocol design
and study execution
❑ We offer you access to the world market – Asia, Europe, Australia, New Zealand,
South America, and North America
How We Can Help
❑
❑
❑
❑
❑
❑
❑
❑
❑
Leading global cardiovascular CRO offering unsurpassed experience
Seamless extension of your operation
Customized project teams that will meet your needs
Instant on-line study status reports
Study accelerators for start-up and future enrollment
Remote data capture to expedite data collection
Responsive communication to sponsor, sites, and labs
Drug and device development consultants
Sponsor satisfaction tools
Your success and goals
drive our actions
Put us on your team
Offices
USA Corporate Headquarters
1401 Rockville Pike, Suite 300
Rockville, MD 20852
Tel: 1.800.933.6462
Europe
Elisabeth-Selbert Strasse 4a
40764 Langenfeld
Germany
Tel: 49.2173.1090.0
www.medifactsinternational.com
Asia
Shui on Plaza, 2310
333 Huai Hai Zhong Lu
Shanghai 200021, China
Tel: 86.21.6385.1744
Clinical Research Services Overview
Quality Services
In today’s market, advances in pharmaceutical research and medical device technology are
so fast paced that companies must establish effective partnerships to ensure rapid and
successful completion of their projects on time and within budget. Medifacts International is
recognized in the pharmaceutical, biotech, and medical device industries as a company with
expertise in effectively managing and executing such programs. We can tailor our services
to meet your needs and budget.
Medifacts International provides a comprehensive set of clinical trial management services:
❑ Protocol development
❑ Project management
❑ Site selection
❑ Data management
❑ Patient and Investigator recruitment
❑ Regulatory support (IDE, 510(k), PMA)
❑ Safety monitoring
❑ Clinical events management
❑ DSMB/CEC management
❑ Regional clinical site monitoring
❑ Medical device product strategy
❑ Core ECG lab
❑ Clinical summary report writing
❑ Drug and device development consulting
Global Clinical Trial Experience
We have been assisting companies with their programs since the creation of our company in
1992. Our international project team has successfully conducted worldwide pharmaceutical
and medical device programs from our global offices in the US, Germany, and China. We
have supported all aspects of clinical trial management over many therapeutic areas – with a
primary focus in cardiovascular, pulmonary, and renal diseases.
Interventional Cardiology Trials — A Specialty of Medifacts International
Medifacts International takes pride in our past achievements with interventional cardiology
studies. Our wide range of services has been used repeatedly to support research in the
use of cardiac and peripheral stents, wound closure, atherectomy, and angioplasty.
Quality Management and Personal Care for Your Project
Medifacts International focuses on your needs for the highest quality clinical study conduct.
Our experienced clinical project teams, monitors, data managers, programmers, and
biostatisticians will complement your team in performing all aspects of your study.
Medifacts International
5/2002