ppr capabilities

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Corporate Capabilities 1580 McLaughlin Run Road Pittsburgh, PA 15241 412-257-4461 www.pprresearch.com Quality Research Today for a Better Tomorrow

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Page 1: PPR Capabilities

Corporate Capabilities

1580 McLaughlin Run Road

Pittsburgh, PA 15241

412-257-4461www.pprresearch.com

Quality Research Today for a Better Tomorrow

Page 2: PPR Capabilities

Primary Physicians Research is an established clinical research provider

We offer:

10 independent, community-based research sites

2 multi-specialty sites

Over 25 years of experience

Over 700 trials.

Dedicated QA/QC department, assuring quality

conduct as well as patient safety

70+ physician network of investigators

A rapidly growing database of over 300,000

patients

Nearly 33,000 study participants (2005-2011)

A strong history of high-quality performance

Strong Enrollment

Reliability

Clean Data

Quick Turnaround

Page 3: PPR Capabilities

History of strong performance

Phase I-IV and OTC clinical trial capabilities

Ability to accommodate specialist trials

Able to handle large, quick enrollments, due to seasonal issues

Consistent history of achieving and exceeding contracted enrollment

Overenrolled in over 30% of studies from February 2006 – February 2011

Primary Investigators, Sub Investigators, and highly trained staff at each site to

oversee and execute the study protocol

Fully equipped neighborhood offices that offer convenience and familiarity to study

subjects.

A proven track record in pediatric and adult research.

Page 4: PPR Capabilities

PPR’s Facility PPR’s dedicated research facility is located within the Jefferson Regional Hospital

State of the art on-site

lab capabilities Separate monitor

room with high -speed

Internet, Fax, Phone.

On site PI

Comfortable waiting room

Page 5: PPR Capabilities

Studies Conducted 300

Total Enrollment Since 2002 30,800

Total Completed 29,974

Studies conducted between January 2002 - February 2011

Patient completion %

Patient drop-out %

Note: The above is all-inclusive of studies taken on by PPR during the period - without regard to size, type, ease/difficulty or

continuance/discontinuance.

2.5-Year Average Study Yield

Jan 2008- February 2011

3.3%

96.6%

97% of patients completed study protocols

Page 6: PPR Capabilities

Note: The above represents PPR’s mix of business by number of studies across its 7 largest customers over the last 10 years

Merck24%

Abbott4%

GSK29%

Sanofi15%

Lilly1%

Pfizer/Wyeth14%

Novartis13%

7 Largest Sponsors – 10 Year Snapshot

PPR has a strong history with numerous pharmaceutical companies:

Page 7: PPR Capabilities

Our quality assurance goal is to achieve, sustain, and improve quality in all

aspects of research within the clinical site arena.

PPR’s QA Department has been organized to drive a data quality focus

throughout the organization. This is achieved by:

Training staff on an ongoing basis

Monthly meetings to identify and correct potential adverse trends in

data quality

A Quality Assurance Liaison visits sites monthly to correct identified

problems and trends and works with PIs to ensure adherence to protocol

and GCP’s

In-house audits are performed and quality indicators are reviewed on a

per trial basis

Identifying and implementing best practices for delivering quality data

Quality Assurance

Page 8: PPR Capabilities

Clinical Conductor manages the large amounts of data involved with the

operation of a clinical trial.

Some of the benefits of using a CTMS include:

Improves recruitment efficiency

Better management of budgets and financials

Tracks advertising responses

Full oversight of multiple trials at multiple sites

Strong Clinical Trial Management Information System

Page 9: PPR Capabilities

Recruitment and marketing: A top priority

PPR has a marketing and site recruitment team who is solely dedicated to patient

enrollment

Marketing techniques play a pivotal role in how targeted patients become aware of

clinical trials

In-house marketing staff creates advertising and marketing tools that are used by

sub-investigators and site personnel to increase enrollment

Staff adheres to ICH guidelines in obtaining IRB approvals for marketing tools

Page 10: PPR Capabilities

PPR utilizes online marketing resources and social media tools for patient

recruitment

PPR maintains an active

online presence through it’s

website, social media

networks, and craigslist

Recent Accomplishments:

Used Craigslist.com to

recruit nearly 75% of goal

patients in an osteoarthritis

study with a contracted goal

of 20 patients

Used Craigslist.com to enroll

over 100% of the set 40

patient goal in a Women’s

Health study

Online marketing and social media tools

Page 11: PPR Capabilities

Trial Experience

Page 12: PPR Capabilities

Diptherial/Pretussis/Tetanus

DTaP

Tetanus/Diphtheria

Varicella

eIPV

Rotavirus

Influenza (intranasal

Influenza (injection)

Influenza (cellular)

Meningococcal A,C,Y,W-135

Meningococcal B

Lyme Disease

Parainfluenza

Pneumococcal

DTaP/IPV/Hep B (Pediarix)

Haemophilus influenza type B

Hepatitis A

Hepatitis B

Human Papillomavirus

Plague

Respiratory Syncytial Virus (RSV)

Anthrax

Diphtherial/Pertussis/Polio/Tetanus

Meningococcal A,C,W,Y

MMRV

Herpes Simplex Virus

Hepatitis AB

PIV3RSV

Dtap/Hib/IPV (Pentacel)

PPR has conducted numerous vaccine trials including:

Page 13: PPR Capabilities

Asthma

Osteoporosis

Osteoarthritis

Obesity

Herpes simplex

Antivirals

Diabetes

Strep throat

Antipyretics

Lipids

Influenza

Pharmacokinetics

Migraine

Atrial Fibrillation

Topical Otologicals

Topical Ophthalmologics

Contraceptives

Arthritis

Back pain

Pharyngitis

Acute bronchitis

Chronic bronchitis

Sinusitis

Pneumonia

Otitis media

Bacterial vaginosis

Infant formula

Hypoactive Sexual Desire

Disorder

PPR has conducted numerous therapeutic and nutritional trials:

Page 14: PPR Capabilities

Our Clients

Page 15: PPR Capabilities

Note: The above is meant to show PPR’s substantial client base developed over time. It should be noted that some of the above listed clients have

since merged, been acquired or otherwise joined with competitors.

Aventis

Abbott

Advancis

Alcon

Allergan

Almirall

Prodesfarma

Aviron

BioCryst

Bristol Myers

Squibb

Cephalon

Chiron

Dimethaid

Dynavax

Dynport

Genentech

Gilead Sciences

GlaxoSmithKline

GlaxoWelcome

Inspire

Iomai

Johnson & Johnson

KV Pharma

Eli Lilly

Mead Johnson &

Company

MedImmune

Merck

NABI Pharmaceutical

Novartis

Ortho-McNeil

Osiris Therapeutics

Pfizer

Pharmacia

Protein Sciences

Roche

RWJ

Sanofi

Sanofi Aventis

Sanofi Pasteur

Sepracor

Schering-Plough

Shire

Takeda

VaxGen

ViroPharma

Wyeth

PPR has a strong history with numerous pharmaceutical companies:

Page 16: PPR Capabilities

Advanced Biologics

Covance

I3 research

Icon

MDS

OmnicareCR

Parexel

Pharmanet

PPD

Quintiles

United Biosource Corp

PPR is proud of its working relationships with government agencies

The National Institutes of Health

Working on protocols that have been initiated by the NIH

The Department of Defense

Worked on vaccines to protect military men and women over the last 5 years

The Division of Microbiology and Infectious Diseases (DMID)

Approved by the DMID to work on vaccine trials in collaboration with NIH and VTEU sites

Created QA/QC program that has been approved by the DMID

Subcontractor for the Vaccine and Treatment Evaluation Units (VTEU) program

Partner with the University of Saint Louis to work with them in numerous vaccine trials

PPR has strong relationships with CROs and others:

Page 17: PPR Capabilities

PPR provides:

Experienced leadership oversees the key functions supporting trial success

Clinical staff receives extensive training and is dedicated solely to conducting

research

Consistent and strong enrollment

Quality data

A team dedicated to delighting our clients!

Page 18: PPR Capabilities

PRESIDENT & CEO

Paul E. Curley

Phone :412-257-4461 ext 212

Cell: 610-745-9155

[email protected]

EXECUTIVE DIRECTOR, COMMERCIAL OPERATIONS

Carol L. Miller, LPN, CCRC

Phone :412-257-4461 ext 127

Cell: 724-518-9531

[email protected]

BUSINESS DEVELOPMENT

Corry Knuth

Phone :412-257-4461 ext 126

Cell: 724-570-4798

[email protected]

Our clinical research team:

Primary Physicians Research welcomes the opportunity to speak with you to provide more

information about our experience conducting clinical trials or for the opportunity to conduct a

clinical trial for you. Please contact us: