Dr. Vince Clinical Research Brochure

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YOUR

FULL

SERVICE

CRO

+1 913-333-3000

www.sponsors.drvince.com

“We created a world-class

CRO by investing in

people, technology and

environmental sustainability”

Bradley D. Vince, D.O.

CEO & Chief Medical Ofcer

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 Efect

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, efciency 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 diferently 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

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