Dr. Vince Clinical Research Brochure

YOUR

FULL

SERVICE

CRO™

+1 913-333-3000

DrVinceCRO.com

2 Your Full-Service CRO

Study Types

Dr. Vince Clinical Research (DVCR) is a full-service CRO specializing in early phase clinical trials

across various designs, therapeutic areas and drug classes. Most of these studies are performed at

our world-class Phase I research facility, with others performed through strategic partnerships with

qualified external sites where DVCR serves as the CRO.

Specialized Studies

Human Abuse

Potential

Experimental

Pain Models

Human Pain

Models

Substance Abuse/

Dependance

Ventilatory

Response

Driving Simulation

Cognitive

Testing

First-In-Human

SAD/MAD

DDI

TQT/Early QT

PK/PD

Proof of Concept (POC)

BA/BE

ADME

Hepatic Impairment

Food Effect

Renal Impairment

Patient Studies

Early Phase Studies

Your Full-Service CRO 3

Full-Service CRO Solutions

Support Services

for Phase I-III Clinical Trials

Data

Management

Biostatistics

& Programming

Multi-Site

Trials

Project

Management

Clinical

Monitoring

Medical

Writing

PK/PD

Analysis

Medical

Monitoring

90-Bed

Phase I Unit

4 Your Full-Service CRO

Multi-Site Trials

The DVCR team has significant experience managing external site activities for the seamless delivery of high-

quality data to our sponsors, including external site feasibility and management. We maintain a network of

strategic sites that have a diverse range of capabilities and patient populations to conduct multi-site clinical

studies (Phase I-III). Our robust site feasibility and selection process ensures that the most capable sites

are participating in your study and that they align with DVCR’s commitment to speed, customer service and

delivering the cleanest data possible.

Our Multi-Site Model

Prioritizing Site

Payments

Custom Built

Site ID and

Selection

Site

Engagement

Our model prioritizes sites that leverage these principles to help our

sponsors reach their milestones faster.

Your Full-Service CRO 5

6 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 7

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

8 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 pharmacology unit

cGMP compliant pharmacy

8 private suites with full baths

Indigo-Clean® light technology to fight COVID

Records storage with gaseous fire supression

Located near multiple hospitals and ERs

Holter monitoring capabilities

Your Full-Service CRO 9

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

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

DVCR has impressive, on-time recruitment,

enrollment and retention rates.

“Their upfront investment in creating

accurate, transparent and defensible

budgets has kept financial guidance

consistent, which has been a refreshing

experience compared to other CROs.

I have been extremely happy with

Dr. Vince Clinical Research.”

Chief Scientific Officer

March 2024

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

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

At DVCR we have one of the most experienced

leadership teams in the country.

“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 15

Committed to the

Environment

Industry Leading Green Design

DVCR prioritizes its commitment to the environment, opting for industry-leading green design in our construction

and cutting-edge conservation strategies. This intentional design has resulted in the award of two Green Globes

Certifications, a comprehensive, science-based rating system with rigorous environmental standards.

Over 500 solar

panels

Demand-

controlled

ventilation

Water

conservation

strategies

Car charging

stations

16 Your Full-Service CRO

In-House Clinical Laboratory

The state-of-the-art clinical laboratory enhances the capabilities of our clinical pharmacology unit by

enabling in-house safety testing, minimizing logistical challenges and enabling us to deliver faster results.

Our clinical laboratory performs a comprehensive range of safety tests, including:

Chemistry and

Immunoassay

Hematology

CBC with 5-Part

Differential

Coagulation

Urinalysis with

Microscopy

Key Features of Our Clinical Lab

Advanced

instrumentation with

high throughput and

comprehensive

test menus

Duplicate

instrumentation for

continuous operation,

eliminating downtime

Full integration with

DVCR’s clinic eSource/

EDC system for enhanced

speed and accuracy

Your Full-Service CRO 17

Tests are performed on four advanced instruments validated per CAP and CLIA

regulations. The instruments are interfaced with our EDC system, allowing for

real-time results and review capabilities. All instruments have been purchased in

duplicate to ensure continuous operation and minimize the potential for downtime.

18 Your Full-Service CRO

7401 West 91st Street,

Overland Park, KS, USA 66212

ADDRESS

+1 913-333-3000

info@drvince.com

PHONE & EMAIL

DrVinceCRO.com

linkedin.com/company/dvcr

WEB & SOCIAL

CONTACT US

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