the power of knowledge. the value of understanding. · 2019-06-25 · all staˇ 85 doctorate104...

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Page 1: The power of knowledge. The value of understanding. · 2019-06-25 · All Staˇ 85 Doctorate104 Master’s Our researchers with advanced degrees 85% 189 Advanced Degrees 169 of our

The power of knowledge.The value of understanding.

Page 2: The power of knowledge. The value of understanding. · 2019-06-25 · All Staˇ 85 Doctorate104 Master’s Our researchers with advanced degrees 85% 189 Advanced Degrees 169 of our

Clinical and Medical Services (CMS) 58 yearsHealth Preference Assessment (HPA) 153 years

Health Economics (HE) 822 years

Biostatistics (STATS) 307 years

Pharmacoepidemiology and Risk Management (EPI) 719 years

Patient-Centered Outcomes Assessment (PCOA) 543 years

Market Access and Outcomes Strategy (MAOS) 443 years

Surveys and Observational Studies (SOS) 267 years

Years of Experience3,300With a team that has over 3,300 combined years of research experience, we provide robust scientific knowledge and the highest ethical standards to help ensure your results will hold up to scrutiny.

Page 3: The power of knowledge. The value of understanding. · 2019-06-25 · All Staˇ 85 Doctorate104 Master’s Our researchers with advanced degrees 85% 189 Advanced Degrees 169 of our

All Sta�

85Doctorate104

Master’s

Our

rese

arch

ers

with

adv

ance

d de

gree

s

85%

Advanced Degrees189169 of our 200 researchers hold advanced degrees, so you can trust that your projects will be staffed by well-educated professionals who use state-of-the-art approaches and proven methods.

Page 4: The power of knowledge. The value of understanding. · 2019-06-25 · All Staˇ 85 Doctorate104 Master’s Our researchers with advanced degrees 85% 189 Advanced Degrees 169 of our

Sta� Retention

43%

22%

35%0–5 years

5–10 years

10–15+ years*

* Includes sta� who started with parent company, RTI International, prior to 2000.

Low employee turnover creates stable project teams—even on multi-year studies. We can provide research continuity on your studies and as your product goes through its development lifecycle.

>5 Years at RTI-HS57%

Page 5: The power of knowledge. The value of understanding. · 2019-06-25 · All Staˇ 85 Doctorate104 Master’s Our researchers with advanced degrees 85% 189 Advanced Degrees 169 of our

Academic Specialties*156+From medicine to industrial engineering, we look at problems from diverse points of view, which brings fresh thinking to your research questions.

English

Public Health

Epidemiology

Psychology

Statistics

Economics

Mathematics

PharmacyBiology

Biostatistics

Business Administration

Industrial Engineering

Accounting

Medicine

Health Policy

Operations Research

Physiology

Biochemistry

Chemistry

Microbiology

Political Science

Health Economics

Nursing

Journalism

Marketing

Sociology

Finance

Law

Clinical Psychology

Applied Statistics

Applied Science

Ecology

Neuroscience

CommunicationPublic Policy Analysis

Pharmacy Administration

Zoology

Veterinary Medicine

Computer and Information Science

Biomathematics

Quantitative Psychology

Pharmaceutical Sciences

Human Resources Management

Molecular Biology

Physics

French

Advertising Education

Chemical Engineering

History

Pharmacology

Animal Science

BusinessManagement

Organic Chemistry

Health Administration

Secretarial ScienceComputer Science

Library Science

Engineering

Biotechnology

Anthropology

Technical Communication

Asian-American Studies

Biological Chemistry

Interdisciplinary Studies

Environmental Economics

Clinical Studies

Neurobiology

Health Behavior / Health Education

Health Psychology

Entomology

Archeology

Paralegal Technology

Counseling

Developmental Psychology

Botany

Business

Clinical Laboratory Science

Electrical Engineering

Information Technology

Systems Engineering

Applied Economics

Bioengineering

Health Science

Mathematical Sciences

Marketing Management

Molecular Genetics

Liberal Arts

Pharmacology-Molecular and Cellular

Medicine and Translational Research

Public Administration

Criminal Justice

Math and Psychology

Voice Music

Health Services and Administration

Public A�airs

* For research staff, including bachelor’s degrees and higher.

Page 6: The power of knowledge. The value of understanding. · 2019-06-25 · All Staˇ 85 Doctorate104 Master’s Our researchers with advanced degrees 85% 189 Advanced Degrees 169 of our

Publications6,500+Our research holds up to the standards of scientific publishing—over the past 5 years, our researchers have published an average of 198 peer-reviewed research articles and another 227 research posters and presentations per year.

ABSTRACTSand Conference Presentations

198averageper year

BOOKS

ARTICLESCHAPTERS

227 average per year

Page 7: The power of knowledge. The value of understanding. · 2019-06-25 · All Staˇ 85 Doctorate104 Master’s Our researchers with advanced degrees 85% 189 Advanced Degrees 169 of our

Projects

With every new project, we build upon our 18 years of company experience across nearly all therapeutic areas. The most studied therapeutic areas are below:

345Psychiatry

1,186Oncology

517CNS/Neurology

338Gastroenterology

192Pain

306Respiratory

108Autoimmune

Diseases

127Vaccines

196Women's Health

104Hepatic

195Hematology

265Diabetes & Endocrine

Disorders

?

326Cardiovascular

?

195Rheumatology

334Dermatology

405Infectious Disease

6,600+

Page 8: The power of knowledge. The value of understanding. · 2019-06-25 · All Staˇ 85 Doctorate104 Master’s Our researchers with advanced degrees 85% 189 Advanced Degrees 169 of our

[email protected]

With rigorous scientific practices and deep industry experience, we help reveal the benefits, risks, value, and potential of your products.

Let our experts help you generate knowledge and greater understanding so that you—and those who regulate, pay for, prescribe, and use your products—can make better decisions.

“Research is to see what everybody else has seen and think what nobody has thought.”

– Albert Szent-Györgyi, MD, PhD Nobel Prize Recipient

Page 9: The power of knowledge. The value of understanding. · 2019-06-25 · All Staˇ 85 Doctorate104 Master’s Our researchers with advanced degrees 85% 189 Advanced Degrees 169 of our

Assess disease and treatment outcomes from the perspective of your patients, caregivers, and health care professionals.

Case StudyTo develop novel PRO measures for use in future clinical trials for irritable bowel syndrome, we collaborated with the Critical Path Institute’s (C-Path) PRO Consortium, three pharmaceutical sponsors, clinical experts, and the FDA. We also collaborated with another client to support the revision and qualification of an existing measure.

Patient-Centered Outcomes Assessment

Measurement StrategiesInstrument DevelopmentPsychometric Evaluation

Utility AssessmentMarket Research

Regulatory Guidance & Support

Page 10: The power of knowledge. The value of understanding. · 2019-06-25 · All Staˇ 85 Doctorate104 Master’s Our researchers with advanced degrees 85% 189 Advanced Degrees 169 of our

Demonstrate your products’ global economic value and impact in the context of health outcomes.

Case StudyWe worked with a manufacturer on a novel drug that has been shown to reduce the consumption of alcohol by alcohol-dependent patients. In close collaboration with the manufacturer, we conducted the cost-effectiveness and budget impact analyses needed to support the drug’s launch across a large number of European markets. This collaborative approach allowed for efficient knowledge transfer between markets and ultimately facilitated earlier treatment access.

Health Economics

Decision Analytic Modeling

Retrospective Health Care Data Analyses

Medical Chart Abstraction

HEOR Evidence Generation & Section 114 Consulting

Interactive Communication Tools

Literature Reviews & Meta-Analyses

Heterogeneity of Treatment Effect Analyses

Page 11: The power of knowledge. The value of understanding. · 2019-06-25 · All Staˇ 85 Doctorate104 Master’s Our researchers with advanced degrees 85% 189 Advanced Degrees 169 of our

Quantify the effects of health care outcomes and interventions on the satisfaction, utility, and behavior of patients, physicians, and other decision makers using stated-preference studies.

Case StudyWe conducted a preference study that allowed for systematically quantifying the tradeoffs patients are willing to make among benefits, harms, and other features of weight loss devices. Designed to provide scientific data on patient preferences to inform clinical trial design for obesity devices, the study resulted in sufficient data to inform FDA regulatory decision-making on a new device.

Health PreferenceAssessment

Discrete Choice Experiments & Conjoint AnalysisBenefit-Risk AssessmentsWillingness-to-Pay Studies

Multi-Criteria Decision Analysis

Page 12: The power of knowledge. The value of understanding. · 2019-06-25 · All Staˇ 85 Doctorate104 Master’s Our researchers with advanced degrees 85% 189 Advanced Degrees 169 of our

Develop and implement value-driven strategies and outcomes research plans throughout all stages of drug development to help you differentiate your product, gain market access, and achieve commercial success.

Case StudyWe collaborated with a client to create a global value dossier for an advanced non-small cell lung cancer treatment that assisted country affiliates in formulating local submission documents and preparing for market access and reimbursement activities. The dossier included a robust value story with evidence-driven messages and key information that effectively communicated the clinical, humanistic, and economic value of the product.

Market Access and Outcomes Strategy

Global Value Dossiers & Other Value Communication Materials

Market Access Strategies

Payer Research

Systematic & Other Literature Reviews

Reimbursement Dossiers & HTA Submissions

Page 13: The power of knowledge. The value of understanding. · 2019-06-25 · All Staˇ 85 Doctorate104 Master’s Our researchers with advanced degrees 85% 189 Advanced Degrees 169 of our

Execute customized real-world observational studies and survey research using robust methodologies to support regulatory commitments, product development, and market access.

Case StudyWe conducted an observational study to understand real-world treatment patterns, health care resource use, health-related quality of life, and indirect costs associated with a dermatological condition. Data collection occurred via medical record abstractions, surveys, and diaries from approximately 700 patients across seven countries.

Surveys and Observational Studies

Patient, Caregiver, & Provider SurveysProspective Studies

Multi-Site & Multi-National Observational Studies

Medical Record AbstractionsNatural History & Registry Studies

Page 14: The power of knowledge. The value of understanding. · 2019-06-25 · All Staˇ 85 Doctorate104 Master’s Our researchers with advanced degrees 85% 189 Advanced Degrees 169 of our

Benefit from our impartial interpretation of your data—from clinical trials to post-marketing studies—so you can trust the results and your stakeholders can confidently act upon them.

Case StudyBased on our experience with patient registries and advanced technical capabilities, we were chosen as a statistical coordinating center for a multi-year patient cancer registry. We developed the statistical analysis plan, provided routine reports, participated on the external advisory board, and helped present data at scientific meetings.

Biostatistics

Clinical Trial Analyses

Observational Study Analyses

Outcomes Research Analyses

Meta-Analyses

Page 15: The power of knowledge. The value of understanding. · 2019-06-25 · All Staˇ 85 Doctorate104 Master’s Our researchers with advanced degrees 85% 189 Advanced Degrees 169 of our

Reduce the uncertainty of risks to patients by investigating disease epidemiology, drug outcome associations, and usage in routine clinical practice and by designing and evaluating the effectiveness of risk management strategies.

Case StudyIn response to a signal in animal studies of a potential association between a medication to treat osteoporosis and osteosarcoma, we are leading a 15-year surveillance study. As part of the surveillance program and to meet a regulatory commitment, we are also conducting a long-term registry linking patient information with cancer registries.

Pharmacoepidemiology and Risk Management

ConsultingDatabase Studies, including Multi-Database

Research ProgramsNon-Interventional Field-Based

Studies & SurveysLiterature Reviews

Page 16: The power of knowledge. The value of understanding. · 2019-06-25 · All Staˇ 85 Doctorate104 Master’s Our researchers with advanced degrees 85% 189 Advanced Degrees 169 of our

Rely on our therapeutic experts—including Dr. Allen Mangel (gastroenterology)—and our experienced CMS team to design and implement clinical studies for your products in any therapeutic area.

Case StudyFollowing the successful completion of a phase 2b study, we designed and implemented a phase 3, 215-center study for the same irritable bowel syndrome drug. We led the FDA negotiations, wrote the study protocol, developed the specifications for the interactive voice and web response system, and designed the CRF. We were responsible for site recruitment, site monitoring, and overall project management, including oversight of the data management and central laboratory vendors. Our biostatistics team wrote the SAP and analyzed the data, and we wrote the clinical study report.

Clinical and Medical Services

Strategic Planning

Study Design

Study Implementation

Analysis & Reporting