CLINICAL OUTCOMES SOLUTIONS Innovative science to capture the patient voice

Our team of experts will provide you with

the most effective clinical outcome solution

to help you make the right patient care value

decisions. We have expertise in qualitative

and quantitative research that will result in

actionable evidence to support your clinical

and regulatory strategy for both the US and

European markets.

Innovative science to capture the patient voice

@cos_coainfo@clinoutsolutions.com www.clinoutsolutions.com

Tara SymondsChief Science Officer & Strategic Lead,

Clinical Outcome Assessments

• Chief Science Officer with over 20 years

of pharmaceutical industry, academic

and consulting experience.

• Most recent industry post was as Head

PRO Centre of Excellence, Global

Market Access, Primary Care Business

Unit, Pfizer Ltd, UK.

• Expertise in COA development with

a focus on qualitative research,

ePRO and comparative effectiveness

research. Leads a team of 17 qualitative

researchers, a team of 5 in study

coordination and a team of 4 in

Medical Communications.

• Published more than 60 peer

reviewed articles and is co-author

of Cappelleri et al (2014) Patient

Reported Outcomes: Measurement,

Implementation and Interpretation,

CRC Press.

Stacie Hudgens

Chief Executive Officer, Strategic Lead

Regulatory & Access

• Chief Executive Officer with over

20 years of experience working in

quantitative science in industry,

consulting and academia.

• Expertise in research design and

statistical and psychometric analysis

for US and European regulatory

submissions including recent work

on use of mixed methods for small

sample size psychometric and statistical

analyses.

• Founder and co-leader of the

Oncology Outcomes: Strategic Advisory

Partnership.

• Founder of the Consensus Panel

for Outcomes Measurement and

Psychometrics: Advancing the Scientific

Standards (COMPASS) – co-sponsored

by COS, the Critical Path Institute and

the University of Arizona.

Helen DollStrategic Lead, Quantitative Science

Claire BurbridgeStrategic Lead, Clinical Outcome Assessments

Louise NewtonSenior Director, Clinical Outcome Assessments

Alex BarsdorfDirector, Clinical Outcome Assessments

Chad GreenDirector, Medical Communications

T H E L E A D E R S H I P T E A MOur senior research leadership team includes highly-skilled qualitative and quantitative

experts. Our philosophy is to be responsive, honest, and efficient thus, alongside Tara

and Stacie, our strategic leaders work hands-on with the project teams to provide

dedicated, continuous support across all facets of clinical outcomes research.

The COS Leadership

team above is supported

by depth and experience

of these research team

members

3 x Associate Director 1 x Senior Research Scientist 2 x Research Scientist 6 x Senior Research Associate 4 x Research Associate 2 x Research Assistant

COA

1 x Associate Director 1 x Lead Study Coordinator 3 x Study Coordinator

Study Coordination

Libby FlodenSenior Director,Biostatistics

@cos_coainfo@clinoutsolutions.com www.clinoutsolutions.com

Jamie CarrollDirector, Medical Communications

1 x Senior Medical Writer 1 x Medical Writer

Med Comms1 x Associate Director 1 x Principal Scientist 1 x SAS Programmer2 x Lead Programmer1 x Senior Research Associate1 x Research Associate 2 x Senior Research Scientist

Quantitative Science PDMA Team 1 x Principal Scientist 1 x Data Management & Collection Lead1 x Research Associate

Jennifer BeaumontSenior Director, Quantitative Science

European Office

Folkestone, UK T: (+44) 1303 661026

United States Offices

Tucson AZT: (+1) 520-325-9510

Chicago IL T: (+1) 312-465-2443

K E Y S E R V I C E S

Clinical Outcome Assessment Strategy: We provide extensive regulatory and payer support

in the US and EU from document development

and submission to meeting attendance and

presentations.

O N C O L O G Y O U T C O M E S

Strategic Advisory Partnership

The oncology-focused research partnership led by Stacie Hudgens, provides our

clients with cutting edge solutions and methodologies in all areas of oncology and

delivers the most innovative patient-related strategies.

Our team of oncology outcome experts will support you on every step of the

journey: from early development to post-approval, including real world surveillance.

We understand what you will need to demonstrate the value (or clinical benefit)

of your product to key stakeholders including patients, providers, regulators, and

reimbursement authorities and we have the expertise to ensure the optimal solution

is provided to you.

STRATEGIC ADVISORY PARTNERSHIP

OncologyOutcomes

L O C A T I O N S

Clinical Outcome Assessment Methods: We have experience of conducting different types

of studies e.g. Prospective real world, exit interviews

and mixed methods.

Outcome Analytics: We offer psychometric and statistical support, COA

evidence generation. Examples include COA analytic

strategy, quantitative prospective studies, outcome

analytics for payer evidence, clinical trial protocol

and SAP development.

Medical Communications: We offer personalized support of medical

communications development from a senior

scientific perspective.

@cos_coainfo@clinoutsolutions.com www.clinoutsolutions.com

Looking for further information? See our website or contact us via email.

Innovative science to capture the patient voice

In 2020, we are celebrating seven years at the forefront of continuous, dedicated support across all facets of clinical outcomes research which informs patient care value decisions.