Women’s HealthWomen’s Health encompasses a wide range of conditions and diseases. At Syneos Health our clinical women’s health expertise spans early-phase development through successful regulatory submission. We have more than 200 clinical experts with women’s health experience on our team. Our solid experience and therapeutically aligned team experts ensure innovative strategies and solutions for your unique trials.

© 2019 Syneos Health™. All rights reserved.

Women’s Health Experience

A dedicated Women’s Health department

88 Trials

5,269 Sites

47,131 Patients

“The only man who behaved sensibly was my tailor; he took my measure anew every time he saw me, while all the rest went on with their old measurements and expected them to fit me.” — George Bernard Shaw

We leverage our experience but understand each program needs an individual strategy that is tailored to your specific needs.

Over 200 clinical staff with Women’s Health experience

Five full-time, in-house OB-GYN physicians

ContraceptionEndometriosisUterine FibroidsOsteoporosisLabor InductionFertility

Breast AugmentationPrevention of Pre-Term LaborOvulation StimulationMultiple SclerosisHIV

100% delivery of key milestones and on-time enrollment performance within the last five years

Picked as a Preferred Provider with a mid-size sponsor focusing on Female Reproductive Health.

“ We picked you because you deliver, and your teams are willing to be flexible when we need to think outside the box for solutions.”

— Project Manager, mid-size Pharma

including

Trials span six continents

© 2019 Syneos Health™. All rights reserved.

All Women’s Health Studies within the last five years have

met or exceeded all milestone and deliverables

Patient Centricity Isn’t Just for Sponsors

Women’s Health studies go far beyond the health of just the women enrolled in the trial. They touch family members in every branch of our family tree. I not only have been involved in the management of clinical trials in this indication, I have been a subject on a trial and I am passionate about giving something back.

Project Director Women’s Health (GBR)

Women’s Health at a Glance

A dedicated Women’s Health department within our General

Medicine Business Unit.

Over 200 clinical staff with Women’s Health experience

Five full-time, in-house

OB-GYN physicians

96%retention rate

Over 46,000 female subjects enrolled in Syneos Health managed Women’s Health Only trials in the last five years

Understanding DiversityConsidering the diverse disciplines that intersect with women’s health studies, we frequently collaborate with other therapeutic departments within Syneos Health to ensure we have considered your trial needs from every angle. For example, we recently conducted a small vaccine trial in pregnant women. We leveraged the extensive vaccine experience of our infectious disease colleagues. The ability to partner with Syneos Health’s therapeutic authorities allows you to receive the most holistic therapeutic expertise for your clinical trials.

Unique-ityThere is never a “one size fits all” outsourcing plan for a clinical trial. This is especially true in the women’s health space, our therapeutically aligned experts listen to your needs and work with you to tailor the design from providing protocol considerations to helping define your risk-based monitoring strategy. We will remain nimble and flexible in order to deliver your study with the maximum speed while preserving data integrity.

© 2019 Syneos Health™. All rights reserved.

Patient Centricity Isn’t Just for PharmaWe focus on finding the right patients for your studies. Our team’s in-depth therapeutic and operational knowledge, combined with their understanding of the nuances in various regions, is paramount in designing operational study plans, prescreening/screening processes, monitoring strategies and more. This is especially true when you are enrolling patients for an

infertility trial, where the condition prevalence is high and the patients are motivated to participate. Yet, often, very specific protocol inclusion/exclusions and medical history requirements can significantly reduce the eligible patient pool. Similar challenges may be found in sexual health trials, again the prevalence is high but the etiology is multivaried and inclusion criteria are stringent.

Asia Pacific Europe North America

Latin America

MENA

24

5350

1411

PHASE I23%

PHASE II24%

PHASE III36%

PHASE OTHER10%

PHASE IV7%

© 2019 Syneos Health™. All rights reserved.

WOMEN’S HEALTH EXPERIENCE SINCE 2013Studies by region and phase

REPRODUCTIVEHEALTH

FEMALE SEXUAL DYSFUNCTION

SEXUALLY TRANSMITTED

INFECTIONSCONTRACEPTION ENDOMETRIOSIS OSTEOPOROSIS

INDICATIONS OF FOCUS

© 2019 Syneos Health™. All rights reserved.

Leadership Team

• Started in Women’s Health as a Site Coordinator in Osteoporosis and Bone Metabolism in 1999

• Over 19 years of experience in Phase I First In Human to Phase III Clinical Drug Development in Pharma Industry and CROs

• Ms. Johnson has had a broad range of responsibilities in clinical research contributing to all aspects of clinical development program planning and study conduct, including site coordinating, monitoring, site management, monitoring management, strategic alliance vendor and CRO management

Women’s Health Global Reach

Job Title APAC EMEAF LATAM North America TOTAL

CRAs 42 110 17 196 365

LCRAs 5 21 4 41 71

Project Managers 14 49 5 64 132

Project Directors 2 4 0 5 11

TOTAL 63 184 26 306 579

Susan JohnsonExecutive Director, Clinical Development

A Dedicated Focus on Improving Women’s Health

Syneos Health™ is very active in supporting biopharmaceutical companies developing innovative solutions in women’s health. Our expertise encompasses:

• Successful design, implementation and execution of 88 women’s health clinical trials since 2013, treating 47,131 patients at 5,269 sites globally

• 14 studies with a fertility focus since 2013, treating 7,726 patients at 373 sites globally

• A dedicated women’s health group within the General Medicine Business Unit (BU) comprised of more than 200 clinical, scientific and regulatory professionals, including five full-time, in-house OB-GYN physicians; executives seasoned in running women’s health trials; accomplished project directors; project managers; and clinical research associates (CRAs)

Considering the diverse disciplines that intersect with women’s health studies, we frequently collaborate across our integrated network of clinical and commercial subject matter experts within Syneos Health to ensure we have considered your trial needs from every possible angle. For example, while recently conducting a tightly defined vaccine trial with pregnant women, we leveraged the

extensive vaccine experience of our infectious disease colleagues to ensure the optimal protocol development for this highly targeted patient population. The unique ability to tap into Syneos Health expertise from across the clinical and commercial continuum allows you to receive the most holistic planning, management and oversight for your clinical trials at every stage.

There is never a “one size fits all” outsourcing plan for a clinical trial. This is especially true in the women’s health space. Our therapeutically aligned experts listen to your needs and work with you to tailor the design from providing protocol considerations to helping define your risk-based monitoring strategy. We will remain nimble and flexible in order to deliver your study with the maximum efficiency while maintaining data integrity.

88Trials

47,131Patients

5,269Sites

© 2019 Syneos Health™. All rights reserved.

About Syneos HealthSyneos Health™ (Nasdaq:SYNH) is the only fully integrated biopharmaceutical solutions organization. The Company, including a Contract Research Organization (CRO) and Contract Commercial Organization (CCO), is purpose-built to accelerate customer performance to address modern market realities. Learn more about how we are shortening the distance from lab to life® at syneoshealth.com.

© 2019 Syneos Health™. All rights reserved.