As a single-source provider for clinical trial planning, trial execution and drug development planning, Medelis is helping biotechnology and pharmaceutical companies by delivering the best total solution - and all the support required - to optimize the return on your clinical research investments. Our approach is driven by a critical mass of clinical research expertise, the ability to identify and focus on the most significant challenges, and your need for prompt results. Our world-class insight and experience in the development and execution of clinical research plans and protocols delivers the decision support you need to chart your next clinical move.

Medelis offers a complete solution from preclinical work through phase III. Our offerings include:

• Clinical trial design and management, including strategic plans for regulatory approval from Phase I through NDA
• Preclinical program analysis, design, management and execution
• Preclinical program review and "gap analysis"
• Site identification, qualification, management, contracting and payment
• Investigator identification and recruitment
• Patient recruitment and accrual strategies
• Project management and monitoring of clinical studies
• Medical management and monitoring
• Data management
• Biostatistics analysis and reporting
• Document preparation and production
• Quality assurance and regulatory compliance
• Medical writing (investigator brochures, protocols, statistical reports, clinical studies, and preparation of documents for regulatory submissions)

Medelis' medical founders, team physicians and clinical trial management physicians are internationally-recognized oncology thought and opinion leaders. They organize and chair sessions at national and international oncology meetings and serve as officers and board members of professional oncology organizations, including The American Association for Cancer Research and The American Society of Clinical Oncology.

Daniel D. Von Hoff, M.D., F.A.C.P.

Michael S. Gordon, M.D.

Howard A. Burris III, M.D.

Mace L. Rothenberg, M.D.

John P. Balser, Ph.D.

James T. Gourzis, M.D., Ph.D.

Sujuan Ba, Ph.D.

John J. Grous, M.D.

Joseph Sinkule, Ph.D.

Medelis has experience managing trials for a wide variety of sponsors:

• Public U.S. pharmaceutical companies
• Private U.S. pharmaceutical companies
• US governmental bodies
• Worldwide, European-headquartered medical care companies
• Private U.S. medical device companies
• European pharmaceutical companies
• Global biopharmaceutical companies
• Private U.S. biotech companies

Medelis Phoenix - Operations
Contact: James Sagar
4105 N. 20th St Ste 215
Phoenix, Arizona 85016
602.840.1101
james.sagar@medelis.com
www.medelis.com

Nashville - Clinical Operations
Contact: David Browning
2200 21st Ave., South, Ste. 300
Nashville, TN 37212
615.297.6537
david.browning@medelis.com
www.medelis.com

Boston - Data Management and Biostatistics
Veristat, Inc.
Contact: Kim Givens
1750 Washington Street
Holliston, MA 01746
508.429.7340

Contact Information

Medelis, Inc.
James Sagar, VP, Business Development
4105 N. 20th St Ste 215
Phoenix, AZ 85016 USA
Phone: 602-840-1101
Fax: 602-840-1102
E-mail:

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