Vince & Associates Brochure

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

on quality research data while recognizing that

speed, responsiveness and accountability are

also core needs of our clients.

We have become one of the premier US

clinical research sites by utilizing The 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.

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

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

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Specialized PharmacyThe 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.

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

Functional to Full-Service OfferingVince & 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

Proo

f-of

-Con

cept

Biologics/Biosimilars

Human A

buse Liability

Phase I/IIa

BioanalyticalServices

DataManagement Biostatistics

ProjectManagement

Pharmacokinetic (PK) Analysis

MedicalWriting

FullService

O�ering

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)

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

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

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

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Quality AssuranceOur 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

Dedication to Our CommunityCommunity 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 CharityVince & 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.

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

State-of-the-Art Facilities

Impressive Recruitment &

RetentionPhysician Research

Model®Healthy Volunteers

& Special Populations

Rapid Study Start-up

Full Service Offering

Vince & Associates Clinical Research Early Stage Clinical Development Services

We’re setting a new standard in early development clinical trials.

Experience the Difference

www.vinceandassociates.com10103 Metcalf Ave. • Overland Park, KS 66212 • Office: 913.696.1601 • Fax: 913.696.1640