This document provides information about Research & Development RA SA, a clinical research organization operating in Latin America. It outlines their mission to provide high-quality clinical trials in the region according to international standards. The management team is described, including the founders Pablo and Santiago Liuboschitz. The company's experience conducting trials in Argentina and expanding to other Latin American countries since 1993 is also summarized. Services offered include clinical monitoring, data management, and logistics support for Phase I-IV trials across therapeutic areas.

1. - Clinical Trials in Latin America -

2. 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.

3. • 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

4. 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.

5. 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

6. 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

7. Why Latin America for Your
Clinical Trials?

8. 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

9. Our Sponsors

10. Our Strengths & Values

11. 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

12. Global Affiliates

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

14. 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

15. 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

16. 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

17. 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%

18.  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

19. 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