Center Overview

INTRODUCTION
Vince and Associates Clinical Research is a leading provider of clinical trial services to the global pharmaceutical and biotech industry. Vince and Associates has assembled an experienced team to supply the pharmaceutical and biotech industry with quality research data and exceptional customer service while maintaining the highest ethical and professional standards.

A DEDICATED RESEARCH CENTER
Vince and Associates Clinical Research is an independent clinical research site with a 12,000 square foot, Phase III Campus (Phase II-IV Studies), 13,000 square foot, Phase I Unit and a 10,000 square foot, 20-bed AASM Accredited Sleep Lab all located in Overland Park, Kansas a part of the Kansas City metropolitan area with a population of nearly 2 million. We are minutes from three major hospitals and 30 minutes away from Kansas City International Airport.

Clinical Research Experience

Vince and Associates Clinical Research have conducted clinical trials in the following areas:

Vince and Associates has worked with the following companies on over 200 clinical trials:

Facility Description

PHASE III CAMPUS

Our dedicated outpatient clinical research site (Phase II-IV) and overnight sleep disorders center is conveniently located off I-435 and Metcalf Avenue and is within 15 minutes of downtown Kansas City.

Equipment & Diagnostic Services Include:

• On-site Lab
• Centrifuge
• Refrigerated centrifuge
• -20° degree C refrigerator
• -70° degree C refrigerator
• Dry Ice
• ECG
• Paper & Digital Polysomnographic units
• High-speed internet access
• Monitor Rooms
• ACLS Physicians & Paramedics
• Lab personnel
• Phlebotomists
• In-house Recruitment Call center
• In-house Advertising/Marketing Team
• 20 bed overnight facility
• Protocol Consultation

PHASE I UNIT

Facility Capabilities

• Intent-to-treat population
• Dose-ranging studies
• Drug Interaction studies
• Bioavailability studies
• Pharmacokinetic/Pharmacokynamic studies
• Food effect
• Ascending Dose
• Vaccine
• First in man
• Special Populations

Equipment & Diagnostic Services Include:

• On-site Lab
• Pharmacy
• Laminar Flow Hood
• Centrifuge
• Refrigerated Centrifuge
• -20° degree C refrigerator
• -70° degree C refrigerator
• Double Locked Ambient Drug Storage
• Double Locked Refrigerated Vaccine Storage
• Dry Ice
• ECG
• Crash Cart
• High-speed internet access
• Monitor Room
• ACLS Certified Physicians & Paramedics
• Lab personnel
• Phlebotomists
• In-house Recruitment Call center
• In-house Advertising/Marketing Team
• 50 bed overnight facility
• Synchronized clocks
• Spirometry
• Automated/manual vital sign monitoring
• Holter Monitoring
• Back-up Power Generator

Amenities

• 50 bed secure, upscale facility
• Closed circuit TV monitoring, secure keycode access
• Central Nursing Station with 24 hour subject monitoring
• Secure , temperature-controlled drug storage and preparation room
• Four dormitories configured for male and female privacy
• Three subject activity areas including reading and computer rooms
• Dedicated monitor room with high speed internet access
• Extensive subject entertainment facilities, including plasma televisions, a theater room with theater seating, arcade games, PS3, pool table and table games
• Courtesy telephones and private lockers for personal belongings
• Emergency alert devices in all bathrooms and dormitories

VINCE AND ASSOCIATES CLINICAL RESEARCH OPENS 50-BED, PHASE I UNIT OVERLAND PARK, KS
Vince and Associates Clinical Research Inc., a leading independent provider of clinical trial services to the global pharmaceutical and biotechnology industry, announced the opening of a 50-bed, Phase I unit in order to keep up with the growing demand for its services.

"This new, upscale unit adds depth to our existing expertise in conducting multi-therapeutic Phase (I-IV) clinical trials and is designed to offer a full range of Phase I Investigative Services to our biopharmaceutical clients," said Dr. Brad Vince, Founder, Chief Executive Officer and Medical Director of Vince and Associates Clinical Research. "The new facility will add over 20 new jobs to the Kansas City area by the end of 2008," Vince said.

The Phase I unit is divided into four distinct dormitory areas that accommodate study volunteers and was specifically designed to maximize subject recruitment and retention. The unit focuses on the comfort of the study volunteers. Amenities for volunteers include adjustable position beds, a modern video arcade, dedicated theater room, high speed computer room, personal bedside DVD players, private bathroom/shower facilities and full-service meal catering.

Based in the Kansas City Metropolitan Area, Vince and Associates Clinical Research has become one of the leading U.S. clinical trial service companies specializing in central nervous system research, one of the most rapidly growing segments in biopharmaceutical research. The company, which also specializes in sleep disorders research, has expertise in conducting overnight and outpatient clinical trials. Reprinted with permission from Medical News Today

Investigator Experience

Bradley D. Vince, D.O.

• CEO & Medical Director
• Participated in over 200 clinical trials
• Intricately involved in all aspects of the clinical trial process (i.e. contracts, regulatory documents, quality assurance, recruitment, etc.)

Steven G. Hull, M.D.

• Director of Vaccine Research and Sleep Research
• Board Certified in Sleep Medicine, Internal Medicine and Pulmonary Medicine
• Participated in over 200 clinical trials
• Nationally recognized, well published and has served in the role of associate editor with several medical journals.

Debra J. Kelsh, M.D.

• Director of Psychiatric Research
• Board Certified in Psychiatry
• Clinical Assistant Professor at the University of Kansas Medical Center
• Participated in over 190 clinical trials

Martin K Kankam M.D., PhD., MPH

• Board Certified in Internal Medicine
• Former Clinical Assistant Professor at the University of Arizona and the University of Nevada
• Former Research Scientist/Epidemiologist at FDA – Rockville, MD
• Participated in over 20 clinical trials

Staff Expertise

Regulatory Affairs Advisor
Gerald E. Vince

Mr. Vince has 37 years of experience with the US Food and Drug Administration. He was Director of the Office of Regional Operations (FDA Headquarters) for seven years in which he served as principal advisor to the Associate Commissioner for Regulatory Affairs (ORA). During this time he had programmatic responsibility for all ORA field operations which included investigations, laboratory and state government coordination.

Mr. Vince had extensive interactions with other federal agencies, foreign governments and industry associations. He has thorough knowledge and understanding of internal agency operations and policy development. He has presented numerous speeches, both foreign and domestic, at PDA, FDLI, RAPS, ISPE, and HIMA sponsored events on FDA regulatory and investigative policy as well as presentations at FDA training courses and industry conferences.

Chris Hardage

Director, Phase I
Michelle Neaderhiser, RN, BSN, CCRC

Associate Director, Phase I
Sue Boxx

Laboratory Director, Phase I
Jana Devine

Clinical Research Coordinators
Our highly experienced clinical research coordinators represent the heart of the Vince and Associates Clinical Research organization. We are proud to have the following clinical research coordinators as part of the Vince and Associates team.

Patient Demographics

Our patient population comes from all age groups and from all 15 counties located in Missouri and Kansas in the Kansas City Metropolitan Area totaling nearly 2 million people. The Kansas City Metropolitan Area provides an ethnically diverse patient population. Our Database of over 24,000 volunteers consists of:

Percentage of subjects by sex:

Percentage of subjects by race:

Percentage of subjects by age group:

Other Information

Regulatory
Our Organization uses a central Institutional Review Board. Document turnaround is usually less than 48 hours.

Recruitment

• 24,000+ Research-Friendly Volunteers
• In-house Call Center (8:00am - 9:00pm)
• 6 Full-time Recruiters

Personnel

• 55 Employees dedicated to Research
• 15 Full-time Study Coordinators
• In-house Quality Assurance Team of former Monitors

Key Points

• Focus - Rapid Start-up, Exceed Enrollment Expectations & Superior Data Quality
• 5 FDA Audits - No 483s Issued
• Providing an environment and experience that says: “Welcome to Clinical Research” like no other place can

Contact Information

Bruce Copeland
Director, Business Development
Vince and Associates Clinical Research
10103 Metcalf Ave.
Overland Park, KS 66212
USA
Phone: 913-696-1601
Fax: 913-696-1640
EMail: bcopeland@vinceandassociates.com
Web Site: http://www.vinceandassociates.com

If you are interested in contacting this center to discuss placing a clinical trial there, please complete and send the E-mail form below. A representative from the research center will then follow up with you.