Tobacco
Harm
Reduction
Solutions
+1 913-333-3000
DrVinceCRO.com
THR@drvince.com
2 Your Full-Service CRO™
Tobacco Harm Reduction
Study Experience
DVCR offers end-to-end clinical and regulatory support from study design through CSR submission.
We operate a 100-bed clinical unit that is backed by a team with deep industry experience with both
tobacco and nicotine products.
Abuse Liability
PK/PD
Biomarkers of Exposure
Biomarkers of Potential Harm
Product use Topography
PMTA-Relevant Clinical Evidence
Bioequivalence
Oral Health Endpoints
Disease Related Endpoints
Longitudinal Safety Studies
Your Full-Service CRO™ 3
Tobacco Harm
Reduction Experts
TC Deluca
Director, THR Operations
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.
Neil Sherwood, PhD
Manager, THR Research
Neil holds a Ph.D. in
Psychopharmacology and a degree
in Experimental Psychology. Since
2016, he has consulted on scientific
and regulatory issues.
Collin Gerringer
Manager, THR Operations
Collin, has as over 12 years of
clinical research experience in rare
diseases, human abuse potential
studies, and tobacco and nicotine
harm reduction.
Ajesh Raju
Senior Project Manager
Ajesh has 15 + years of experience in
the biopharmaceutical and medical
device industry, specializing in
hands-on project management of
tobacco harm reduction studies,
including operations, planning, vendor
coordination, and daily execution.
4 Your Full-Service CRO™
Luxurious Phase I Unit
Designed Differently
We operate one of the world’s most innovative and technologically advanced research centers, purpose-built
to support speed, efficiency and high-quality data. Our facilities provide an ideal environment for seamless
study execution.
75,000 square foot
research complex
100-bed clinical
pharmacology unit
cGMP compliant
pharmacy
State-of-the-art
clinical laboratory
Your Full-Service CRO™ 5
Smoking Rooms
Housed within our facility are seven indoor exposure rooms, including two large 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/AL data
collection while
volunteers use study
products
Dedicated ad-libitum
and controlled-use
environment
Allows direct
observation of product
use behavior
Accomodates
different product
types
6 Your Full-Service CRO™
Biometric facial screening
Our pharmacy team has over 50 years of combined experience in early phase clinical research, with
expertise in the handling and preparation of investigational products across various routes of administration.
cGMP Compliant Pharmacy
Located within our Phase I unit, the 2,500 square foot cGMP compliant compounding pharmacy contains five
distinct areas for the preparation and storage of investigational products:
Main pharmacy area with closed cell insulation
for maintaining environmental controls for
ambient storage of investigational products
Controlled substance licensing for Schedules I-V
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 API powder
Independent narrow spectrum
570nm amber LED lights for handling
photosensitive API
Labconco XPert Filtered Balance System
HEPA filtration throughout entire pharmacy
Biometric facial screening
Your Full-Service CRO™ 7
Expert Insight and Support
At DVCR we have one of the most experienced
research teams in the country.
At DVCR, we invest in people, cultivating unmatched expert insight and support. Each member of our
diverse research 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
8 Your Full-Service CRO™
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
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
Unsurpassed Recruitment
and Retention
Your Full-Service CRO™ 9
What Differentiates Us?
Every single detail of our organization is built to deliver excellence. With a highly experienced clinical team, we
consistently meet recruitment goals and achieve key milestones for our sponsors.
Team Continuity
Maintining key leadership
throughout every study
Flexible Partner
Physician led and adapting to your
needs at every stage
Technology & Innovation
A leader in technology-powered
clinical research
Rapid Response Time
Delivering rapid communication and
exceptional customer service
10 Your Full-Service CRO™
Support Services
for Clinical Studies
Full-Service CRO Solutions
Data
Management
Biostatistics
& Programming
Phase I-II
Multi-Site
Trials
Project
Management
Clinical
Monitoring
Medical
Writing
PK/PD
Analysis &
Modeling
Medical
Monitoring
100-Bed
Phase I Unit
Central
Laboratory
Services
Your Full-Service CRO™ 11
Phase I-II Multi-Site Trials
By combining our full suite of CRO support services and a network of strategic site partners globally, we manage
complex multi-site trials in patients and healthy normal volunteers across a diverse range of therapeutic areas
and trial designs.
Our Model
We prioritize sites that align with our principles to help our sponsors reach their milestones faster.
Quality sites are imperative for a
successful trial.
Sites require expedited
payments to avoid study delays.
This reinforces our collaborative,
true partnership approach.
Site ID and Selection
Prioritizing Site Payments
Site Engagement
We provide sites with essential
tools, support and communication.
Central Laboratory Services
Customizable Kits
Rapid Turnaround
Reduced Site Burden
Dedicated Team
Data Integration
Regulatory Confidence
Florence Trial
Operations Platform
The Florence Trial Operations Platform accelerates the study
startup and enables seamless document distribution, tracking
and remote monitoring across our sites. It provides real-time
visibility and quality control, eliminating the need for back-and-
forth exchanges and integrates directly with Trial Master Files
(TMFs) for efficient filing and document updates. Whether sites
use a Florence account or paper ISF, this tool keeps DVCR
connected and informed—especially during critical phases such
as startup and site activation.
12 Your Full-Service CRO™
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.
Technology Powered
Clinical Research
Clinspark eSource/EDC and Clinic
Workflow Automation System
Florence electronic Investigator Site File/eTMF
Wireless Temperature Monitoring
Touchless Biometric Access Controls
Wifi-Telemetry with Redundant Server Storage
By using these and other automated systems,
we have transformed standard industry
practices to become a leader in technology-
based clinical research.
Medidata CTMS
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™
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
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CONTACT US