15 Years Clinical Research Excellence Premier US Site
1.
2. Fifteen Years
of Research Excellence
Vince & Associates Clinical Research has been
providing clinical research services to the
global biopharmaceutical industry for fifteen
years. We have assembled an experienced
team of clinical research professionals focusing
onqualityresearchdatawhilerecognizingthat
speed, responsiveness and accountability are
also core needs of our clients.
We have become one of the premier US
clinical research sites by utilizingThe Physician
Research Model® of operation where study
teams are led by highly experienced Principal
Investigators intricately involved in all aspects
of the clinical trial process.
Our expertise, access to both healthy normal
volunteers and an extensive spectrum of
special populations combined with high
quality data have been fundamental in the
award of five-year contracts with both the
U.S. Food and Drug Administration and the
National Institute on Drug Abuse.
3. Company Headquarters
Our Model
• Full range of services focused on early stage clinical development
• Upscale facilities with boutique hotel-like accommodations
delivering industry best recruitment and retention rates
• Rapid regulatory submission and contract process
• Physician involvement in every aspect of the clinical trial process
• Over 90 sponsor and agency audits
• 7 FDA audits with no 483s issued
• Expertise in a wide range of therapeutic indications with both
healthy normal volunteers and special populations
Setting a New Standard in Early
Development Trials
• Multi-million dollar Clinical Pharmacology Unit
• 10 unique and luxuriously designed research suites
• Bed capacity of over 100
• Bedside, 20-inch touchscreen entertainment systems
• State-of-the-Art safety and security features
• Full-time, dedicated staff
• Senior staff tenure with an average of 10+ years at Vince Associates
• In-house specialized Pharmacy
4. Recruitment Highlights
• Over 2 million ethnically diverse residents in the Kansas City metro area
• 74,000 research-friendly volunteers in our validated database
• Full-time in-house recruiting staff working 6 days per week
• Staff facilities designed for optimum recruitment retention
• Extensive screening histories obtained for effective recruitment
Creating Experiences to Remember
• Bedside, 20-inch touchscreen entertainment systems
• Private spa-like bathrooms
• Catered cafeteria with customized menus designed by registered dietitian
• Game room with arcade games
• Video game room with multiple gaming stations
• Movie room with big screen and theatre seating
• Successful completion of trials with long confinement
• Continually enhancing the volunteer experience
5. Specialized Pharmacy
The Vince Associates Clinical Research Early Development
Campus includes a robust in-house pharmacy. Our Pharmacists
have extensive knowledge and experience in the preparation
and administration of studies via oral, sublingual, intranasal and
parenteral (IV, IM, subcutaneous) routes.
Capabilities
• Full-time Clinical Research Pharmacists
• USP 797 certified clean room with Class II Biological Safety
Cabinet
• Negative pressure extemporaneous compounding room
equipped with HEPA filter and PowderSafe Ductless Balance
Enclosure
• Extensive experience in extemporaneous preparation with
IV, IM and SC administration, including biologics
• Over-encapsulation, manipulation and usability processing
of Abuse Deterrent Formulations and the blinding of
referenced and comparator products
• Controlled substance license
• 24/7 monitoring of storage environment
Access to the pharmacy is controlled by
electronic security access and video monitoring.
Facial recognition software was also added to
the pharmacy as an additional security feature.
6. Populations
Therapeutic Experience
Early Development Trials in
HNV Special Populations
• Proof-of-Concept (POC)
• Adaptive Design: HNV Special Populations
• First-in-Human (FIH)
• Single Ascending Dose (SAD)
• Multiple Ascending Dose (MAD)
• Bioavailability/Bioequivalence (BA/BE)
• Pharmacokinetics/Pharmacodynamics (PK/PD)
• Dose-Ranging and Tolerability
• Food Effect
• QT/QTc
• Drug-Drug Interaction
• Human Abuse Liability
• Biosimilars
• Abuse Liability • Methadone/Buprenorphine
• Allergy • Metabolic Disorders
• Analog Classroom (ADHD) • Obesity
• Cardiovascular • Ophthalmology
• Central Nervous System • Pain and Inflammation
• Cognitive Testing • Pediatric
• Dermatology • Psychiatry
• Diabetes • Post-Menopausal Women
• Electroencephalography • Pulmonary
• Elderly • Sleep Disorders
• Gastrointestinal • Substance Abuse
• Healthy Normal Volunteers • Women’s Health
• Hematology • Vaccines
• Hepatitis • Others upon request
7. Functional to Full-Service Offering
Vince Associates Clinical Research provides top tier clinical trial services custom tailored to your individual project needs. Comprehensive, full-service offerings
are available from protocol development and study design through bioanalytical support and clinical study report submission.
Clinical Support Services
• Project Management
• Protocol Design and Writing
• Study Monitoring
• Data Management
• Biostatistics
• PK/PD Analysis
• Medical/Report Writing
Proof-of-Concept
Biologics/Biosimilars
HumanAbuseLiability
Phase I/IIa
Bioanalytical
Services
Data
Management Biostatistics
Project
Management
Pharmacokinetic
(PK) Analysis
Medical
Writing
Full
Service
Offering
Bioanalytical Services
• Method Development/Transfer/Validation
• LC-MS/MS and Ligand Binding Assay Platforms
• Immunogenicity Services
• Biomarker Assays (“fit-for-purpose”and definitive
quantitation, single and multiplex)
8. Human Abuse Liability
Vince Associates’physicians have 40 years of combined substance abuse
clinical experience and are experts in working with both recreational drug
users as well as substance abuse volunteers. Our team has significant
expertise in the identification of appropriate study subjects for for Human
Abuse Liability studies and other substance abuse studies including
cocaine, methadone/buprenorphine, hydromorphone challenge and
alcohol interaction.
• Experienced in a diverse range of HAL studies including opioids (oral
nasal snorting), sedative-hypnotics and stimulants
• Access to a large database of recreational drug users for rapid study
enrollment
• Touchscreen electronic visual analog scales (eVAS) for cognitive
assessments
• Pharmacy capabilities include over-encasulation, manipulation and
usability processing of Abuse Deterrent oral dosage forms and the
blinding of referenced and comparator products
9. Early Cardiac Safety Assessment
In December 2014, the news of a technique for assessing QT/QTc from
data captured during Phase I clinical trials was shared during the FDA-
hosted Cardiac Safety Research Consortium (CSRC) meeting.
The methodology includes a significant increase in ECG data evaluation,
use of improved algorithms for cardiac assessment and careful analysis
of compound systemic exposure to create a powerful combination of
maximal data points in a smaller clinical trial performed as part of an early
stage study.
As a member of the CSRC, Vince Associates participates with
industry leaders on key issues that impact cardiovascular safety, including
alternative approaches to ICH E14 for the assessment of arrhythmia
liability in early drug development.
Development Advantages of Early QT
• Early QT safety assessment of drug candidates
• Confirmation of preclinical cardiovascular safety findings for more
informed development decisions and/or potentially“save”drugs that
have tested positive in non-conclusive preclinical screening methods
(i.e. Purkinje Fiber, ion channel and HERG assays)
• De-risk drug candidates by providing a more precise indicator of
arrhythmia liability prior to late stage development investment
• Improved development package for licensing or further in-house
development
• Considerable time and cost savings if TQT waiver can be obtained
10. Physician Research Model®
Full-time, dedicated research physicians oversee all aspects of clinical trials conducted. This ensures proper medical and technical
procedures are completed to the highest degree of quality from subject recruitment to subject discharge.
Brad Vince
DO
CEO Medical Director
Participated in over 450
clinical trials in all phases of
development
Debra Kelsh
MD
Board Certified in Psychiatry
Former Clinical Professor of
Psychiatry at the University of
Kansas Medical Center
Martin Kankam
MD, PhD, MPH
Former Research Scientist and
Epidemiologist at the FDA
Former Clinical Professor at
the University of Arizona and
University of Nevada
11. `
Quality Assurance
Our internal Quality Assurance Team ensures that clinical trials are conducted
per protocol and within ICH/GCP guidelines.
• Comprehensive SOPs and employee training records
• Strong foundation in ICH/GCP/CFR highlighted by 7 FDA Audits with no
483s issued and over 90 sponsor audits
• Real time Quality Control for all study processes
• Significant company resources invested in QA/QC
Safety Commitment
• 24/7 Advanced Cardiac Life Support (ACLS) provider coverage on site
• All remaining clinical staff are Basic Cardiac Life Support Certified
• Subjects are assessed daily by an Investigator
• 2 Crash Carts available on site
• Scenario-based response training
• 32 channel telemetry with pulse oximetry
• 52 strategically placed panic buttons
• 24/7 video surveillance/controlled access throughout the facility
• Close proximity to 3 major hospitals including a trauma center
12. Dedication to Our Community
Community involvement is an important cornerstone in the Vince
Associates Clinical Research corporate culture.
Our company is dedicated to making a positive impact in our community
through the collaboration with different local and charitable organizations
through both volunteer efforts and financial support.
Lights for Charity
Vince Associates holiday lights display is well known throughout the entire
community. The animated display of over 230,000 lights is syncronized to
holiday music and is one of the largest in the Kansas City metropolitan area.
The popularity of the lights display made it an excellent venue to raise
funds for two local charities, Make-A-Wish Foundation and Children’s Mercy
Hospital, to benefit children in the Kansas City area.
To find out more about the event or the charities you can visit
www.LightsForCharity.org.
13. Coming Soon
Vince Associates Clinical
Research Multi-Million Dollar
Research Campus Expansion
Vince Associates has broken ground on
a new $5 million expansion of our research
campus. The new building will allow Vince
Associates to keep pace with demand from
the global biopharmaceutical industry for the
conduct of complex clinical trials.
The new building will include:
• An expanded recruitment center to
support the demand to recruit qualified
volunteers for complex early development
trials
• An advanced medical/surgical suite for
specialized clinical trial procedures such as
endoscopies, biopsies and EEGs
• Luxuriously designed research suites ideal
for volunteers participating in overnight
clinical trials
• A state-of-the-art pharmacy to provide
additional capabilities for extensive drug
preparation methods
