Tobacco
& Nicotine
Harm
Reduction
+1 913-333-3000
DrVinceCRO.com
THR@drvince.com
2 Your Full-Service CRO™
Tobacco Harm Reduction
Study Types
DVCR operates a 90-bed clinical unit located in the Kansas City Metropolitan and has a team of
experienced professionals who have conducted a large number of tobacco and nicotine studies
with many different product types.
PK/PD
Abuse Liability Assessment
Topography
Bioequivalence
Biomarkers of Exposure
Standard Studies
Longitudinal Studies
Biomarkers of Potential Harm
Disease End Points
Behavioral Science (RWE)
Actual Use
Tobacco Product Perception and Intention (TPPI)
Label and Comprehension
Sensory Studies
Oral Health
Your Full-Service CRO™ 3
Tobacco Harm
Reduction Experts
Claudia Kanitscheider
Associate Director,
Behavioral Science
Claudia has over 15 years
of leadership and scientific
expertise in behavioral
research, focusing on nicotine
and tobacco harm reduction
studies that support industry
regulatory requirements.
Collin Gerringer
Senior Study Manager
Collin, with over 10 years of
clinical research experience,
leads study management
for tobacco and nicotine
harm reduction and abuse
potential studies.
George Hardie
Vice President,
Clinical Development
George has over 37 years
of expertise in inhalation
toxicology, clinical research,
respiratory disease and
tobacco harm reduction.
Neil Sherwood, PhD
Manager, Tobacco Harm
Reduction Research
Neil holds a Ph.D. in
Psychopharmacology and
a degree in Experimental
Psychology. Since 2016, he
has consulted on scientific and
regulatory issues.
Steven Hull, MD,
FCCP, FAASM
Medical Director, Principal
Investigator & Pulmonologist
Dr. Steven Hull, has over 30
years of clinical experience
in pulmonary disease. He has
served as an Investigator or
Medical Monitor in over 550
clinical trials.
TC Deluca
Associate Director,
Project Management
TC has over 25 years of
clinical research experience.
Before DVCR, she led
clinical operations at a major
tobacco company, gaining
expertise in harm reduction
and study design.
4 Your Full-Service CRO™
Luxurious Phase I Unit
Designed Differently
We designed one of the world’s most innovative and technologically advanced research centers to achieve
ultimate speed, efficiency and enhanced data quality. To accomplish this, we built our facilities from the
ground up, creating the optimal environment for study execution. Leveraging the newest technology and
equipment alongside our highly experienced clinical team allows us to fulfill our recruitment and quality
commitment to sponsors.
75,000 square foot research complex
90-bed clinical unit
cGMP compliant pharmacy
8 private suites with full baths
7 smoking rooms with a bespoke HVAC system
Records storage with gaseous fire supression
Located near multiple hospitals and ERs
Holter monitoring capabilities
Your Full-Service CRO™ 5
Smoking Rooms
Housed within our facility are seven indoor exposure rooms, including two large rooms and five individual
rooms. Each room is equipped with advanced air handling and ventilation/filtration to allow us to conduct these
unique types of studies at our site.
Design allows
different group sizes
Enables PK data
collection while subjects
use study products
Dedicated Ad-Lib
smoking room
Allows viewing of
subject product use
behavior
Can accomodate
different product
type use
6 Your Full-Service CRO™
Powered by People
Unmatched Expert Insight and Support
At DVCR, we invest in people, cultivating unmatched expert insight and support. Each member of our
diverse leadership team was hand-selected to provide expertise and practical insights into every facet of
study execution.
Robust training
Cutting-edge
technology
Positive and
uplifting work
culture
A workplace
designed around
collaboration
“The project managers, clinical
monitors, investigators, entire clinical
pharmacology unit team, medical
monitor and data managers have years
of experience with the management
and conduct of early phase studies. I
highly recommend DVCR.”
Physician Scientist and Biotech Executive
March 2024
Your Full-Service CRO™ 7
Full-Service CRO Solutions
Support Services
for Clinical Studies
Bioanalysis
Data
Management
Biostatistics
& Programming
Multi-Site
Trials
Project
Management
Clinical
Monitoring
Medical
Writing
PK/PD
Analysis
Medical
Monitoring
90-Bed
Phase I Unit
8 Your Full-Service CRO™
Multi-Site Trials
DVCR has a network of external research sites with a proven track record of undertaking nicotine and tobacco
harm reduction studies to provide a multi-site approach for our sponsors. When this is the case, DVCR has a
robust feasibility and qualification process to ensure that only the most qualified sites are participating in your
study to ensure recruitment milestones and study deliverables are met on time.
TM
Your Full-Service CRO™ 9
10 Your Full-Service CRO™
Unsurpassed Volunteer Recruitment and Retention
At DVCR, a significant component of being designed differently is how much we value the volunteer experience.
This enables us to achieve unmatched speed and diversity in recruitment. You can see this sentiment at work
the second you walk through our doors. Additionally, the entire DVCR campus features an array of volunteer
amenities, each one thoughtfully planned to enhance the volunteer experience in order to optimize recruitment
and retention.
Sports-themed dining
room with plush seating
and nine large-screen TVs
Private rooms
designed to receive
phone or video calls
Gaming room
equipped with state-of-
the-art systems
VIP lounge with floor-
to-ceiling windows
and spacious seating
Committed to
enhancing the
volunteer experience
Your Full-Service CRO™ 11
Our pharmacy team has over 50 years of experience in early clinical development, with expertise in the
handling and manipulation of investigational products across various routes of administration.
cGMP Compliant Pharmacy
Housed within our Phase I unit, the 2,500 square foot cGMP compliant compounding pharmacy contains five
distinct areas for the preparation and storage of study drugs:
Main pharmacy area with closed cell insulation
for maintaining environmental controls for
ambient storage of study drug(s)
Locking custom floor-to-ceiling cabinetry for
non-controlled substances
USP-795 compliant negative pressure
extemporaneous preparation room
USP 797 compliant ISO 8 (Class 100,000)
Anteroom
USP 797 compliant ISO 7 (Class 10,000) Clean
Room
Spacious storage area with cold storage units
Pharmacy Features
and Equipment
Thermo Fisher cold storage units with
24/7/365 temperature monitoring
Secured storage of controlled substances
Class II, Type A2 biological safety cabinets
Semi-micro analytical balance for
weighing powder API
Independent narrow spectrum
570nm amber LED lights for handling
photosensitive API
Labconco XPert Filtered Balance System
HEPA filtration throughout entire pharmacy
Biometric facial screening
12 Your Full-Service CRO™
Experience True Tech
Integration From
Start to Finish
Utilizing cloud-based technology and the
highest levels of encryption available, we
provide secure data with optimal redundancy,
reliability and accessibility.
Our design features integrated
platforms including:
eSource/Clinic Workflow Automation System
Electronic Data Capture (EDC)
Building Management System
Inventory Management System
Clinic staff utilize real-time hands-free
communication devices
Wireless Temperature Monitoring
Wifi-Telemetry with Redundant Server Storage
Touchless Biometric Access Controls
By using these and other automated systems,
we have transformed standard industry
practices to become a leader in technology-
based clinical research.
Envisioned Around
Technology
Your Full-Service CRO™ 13
Smarter Faster Data®
We define Smarter Faster Data® as accurate, actionable and audit-ready.
This accelerates your time in the clinic and speeds up review, quickly
producing clean and robust data through seamless tech integration.
Expedited IRB review via
our collaboration with
WCG IRB
Strategic partnership
with Clario to deliver
high-quality cardiac
safety data
Dedicated vital signs
machines at each bed to
reduce data variability
Equipment integration
with eSource/EDC for
automatic data upload
Deployment of bar code
scanning for improved
data quality and subject
verification
Real-time Sponsor
access to live data
14 Your Full-Service CRO™
“As a result of DVCR’s experience and
determination, this study was completed
on time and within budget. I would
highly recommend using DVCR for
clinical studies without reservation. As
a company, we will be using DVCR for
future clinical pharmacology studies.”
Executive Director of Clinical Pharmacology
August 2024
Your Full-Service CRO™ 15
What Differentiates Us?
Every single detail of the company and facility has been reimagined
to provide the optimal environment for clinical study execution.
At DVCR we believe that all studies deserve the absolute
best in planning and operational conduct.
This principle is built on the foundation of our four pillars:
Luxurious
Phase I Unit
Technology &
Innovation
Environmental
Sustainability
Investing in
Our People
16 Your Full-Service CRO™
7401 West 91st Street,
Overland Park, KS, USA 66212
ADDRESS
+1 913-333-3000
THR@drvince.com
PHONE & EMAIL
DrVinceCRO.com
linkedin.com/company/dvcr
WEB & SOCIAL
CONTACT US