- Clinical Trials in Latin America -

Our Mission

• To provide professional, cost- effective and timely assistance to our Clients to contribute to their drug development efforts

• To guarantee the collection of high-quality clinical data in Latin America, in compliance with research ethics, international standards and local regulations that warrant subject protection.

• To become the leading experts in clinical trials in Latin America due to our quality services, the guarantee of study subject protection, our reliability in providing outstanding results and establishing long-term, trusting relationships with our Clients.

Our Vision

Who We Are - Management

Pablo Liuboschitz, BS, MBA Founder & CEO •Pablo is a Bachelor in Science and holds a Master in Business Administration. •He was co-founder of Research & Development CRO in 1993. •He was a clinical research advisor since 1995 and was also a researcher and CRA. •He is currently the CEO of Research & Development CRO. •Current Secretary of Argentine Chamber of CROs.

Santiago Liuboschitz, MD Founder, VP & Medical Affairs Manager •Santiago is a physician, graduated in 1961 from the University of Buenos Aires. He specialized in Internal Medicine and since 1972 held leadership roles in several multinational companies. •He was the Medical Director at Merck Sharp & Dhome between 1972 and 1980. He later became the Head of Clinical Research at Ciba-Geigy Argentina until 1992. In 1993 he took the Southern Cone Regional Medical Director position at SmithKline Beecham until 2000. •He founded Research & Development CRO in 1993 and was President until 2008. •He is currently the Vice-President and the Medical Affairs Manager.

Who We Are - Management

Evolution and Expansion to Latin America

We are the only local CRO with more than 20 years of experience and continuity in the clinical research enterprise in Argentina & Latin

America.

1993 2000 2001 2009 2014

Brazil Mexico

& Chile

Uruguay Global Consortium

Argentina

Why Latin America for Your Clinical Trials?

Why choose Latin America?

• Large, urban and naïve patient population (~80% concentrated in urban centers)

• High patient enrollment and retention rates • Highly experienced investigators, with GCP

training • Fewer trials competing for the same patients

(more patients per site) • Regulations and laws for clinical research aligned

with international standards • Disease profiles and therapeutic standards that

resemble those of US and Europe

• Area: 21,069,051 sq. km • Population: 569 million (est 2008) • Longer life expectancy (around 74 years) • High fertility rates • Pharma market value of $80bn in 2013, up

from $50bn in 2010 • Only 2 languages: Spanish and Portuguese. • Similar time Zone as the USA/Europe (0 – 5

hours difference)

• Proven high-quality data. Most of the research conducted in the region belongs to multinational, industry-sponsored trials for FDA/EMA submissions.

• Laboratory staff with IATA certification/PK experience • English language literacy • Expertise in working with IWRS and EDC systems • Quality proven regional vendors for support services • Seasonal reversal, enabling continuous enrolment

Our Sponsors

Our Strengths & Values

HIGHLIGHTS • “Boutique Services”

• Expert Team Assigned to Each Project • Roles & Staff Number Adjustable to Project’s Needs and In-House Staff Number/

Availability or Global CRO • Easy Process for Scope Changes & Implementation of Upgrades & Downgrades • No Red Tape. • Team Players + Open Communication + Mid-Size Structure= Quick-Decision Making Process

Global Affiliates

HIGHLIGHTS • Clear and Open in Our Communications • Full Visibility of Our Clinical Trial Operations to Our Clients • Facilitates Sponsor Oversight of the Project

HIGHLIGHTS • > 20 Years of Experience in the Region • Vast Experience in Project Management & Regulatory Strategy • Proven Quality • Senior Staff Assignment with Low Turnover • Large & Reliable Investigator Network • True Partnerships with Clients and Site Staff

Clinical Trial Services (Phases I to IV) • Clinical Study Feasibilities • Project Management and

Strategic Planning • Regulatory Study

Management • Budget Negotiations • Investigator Agreements • Clinical Trial Monitoring • Safety and Pharmacovigilance • Quality Assurance • Insurance for Clinical Trials • Import/ Export Licenses • Legal Representation

• Development of Study Documents • Data Management • Statistics • Medical Writing • Patient Services (Recruitment &

Retention) • Clinical Trial Logistics (Drug

Storage, Distribution & Destruction, Collection of Study Samples, Cold-Chain Logistics, etc.)

• Vendor Selection, Qualification and Oversight

Other Services • Bioequivalence Studies

– Complete package or partial services – BE studies performed at the facilities in Argentina,

Brazil & India are accepted by Regulatory Authorities In Argentina, Brazil, Chile and Perú

• Product Registration – Medical & regulatory advise and expert support

for product registration in Latin America

Areas of Main Expertise

Oncology

Cardiovascular Diseases

Ophthalmology

Pulmonary Hypertension

Infectious Diseases

Metabolic Diseases

Others (Medical Devices, Rheumatology, CNS)

35% 20%

15% 13% 9%

5%

3%

More than 20 years working in Argentina and other Latin American Countries for North American and European Pharmaceutical /Biotechnology Companies, in several diseases and phases of investigation.

Through our wide experience, quality standards, fluid communication, and highly qualified

staff we will develop your clinical programs successfully, in a cost-efficient way and in compliance with all applicable regulations.

Fully aware about the research regulations in place, the peculiarities, the culture, the

healthcare and the clinical research medical environment in every country in Latin America. This allows for a strategic regulatory vision and for the anticipation of potential challenges for each project so that preventive actions are implemented.

Due to our flexibility and emphasis in close and clear communications, we will fit in swiftly

and integrate to your R&D study team, reducing the burden or work overload generated in-house when the vendor is a large CRO.

Added Value of Research & Development RA SA

Any questions? Reach us Anytime! Pablo Liuboschitz, BSc - MBA

CEO pabloliuboschitz@rd-latam.com + 5411- 4772-3924/4771-4600

Skype: @pabloliuboschitz www.rd-latam.com