Rheumatology Specialist Internal Medicine Specialist

Certified Physician Investigator (Academy of Pharmaceutical Physicians and Investigator)

Master in Business Administration Master of Pharmacology Clinical Research

Principal Investigator Author of book “On Clinical Trials and Magical

Realism" Articular Foundation President

(Science, Technology and Society)

Jorge Velasco Zamora

The city of Quilmes is located in the core of the

southeast suburbs, 17 km from Buenos Aires and 30

minutes from Ezeiza International Airport

With 3,5 M inhabitants, the area is part of Greater

Buenos Aires Agglomeration, whose population density

is the highest in our country and the second in South

America (after San Pablo)

A Brief History

CER Medical Institute was born in 1987

as a medical institution dedicated to

assistance, teaching and academic

research in the field of rheumatology

180 square feet were leased

The team included two rheumatologists,

a kinesiologist and a receptionist

Our own building was opened in 1994.

Had 750 square feet

A Brief History

First trial was iniciated in 1989

The research team included a PI, a SI,

a SC, a nurse and no experience.

in 2002 we attached a bordering

property, totaling about 2000 square

feet. The infrastructure was planned to

meet the needs of clinical research.

A Brief History

At the same time we began training and recruiting human resources according to skills required.

In 2004, with the incorporation of the oncology service, we became a multispecialty site

Then joined diabetes and HIV studies

In 2009 we created Articular Fundation, a non profit organization related with Science, Technology and Society

Today Several pharmaceutical and Biotech companies and CRO´s have trusted us

Trained researchers in

Onconlogy

Rheumatology

Osteology

Gastroenterology

Cardiology

Infectology

Neurology

Psychiatry

(8 researchers have masters

in clinical trials)

Today

Support human resources:

4 full time study coordinators

1 full time pharmacist

2 full time nurse

1 part time laboratorist

1 full time radiologist

2 full time administrators

Organizational processes

We work with SOP´s and written processes (value stream mapping) that allows us to improve our performance by identifying issues early

Quality assurance is performed by external consultants through an internal monitor and systematic audits

IRB with a structure and procedures designed in compliance with national and international recommendations (GCP compliant)

Facilities • Monitoring and coordination area

• Individual workstations

• Individual lockers for the storing

specific files

• Dedicated server

• Direct telephone lines (IP)

• Broadband Internet (Wi Fi)

• Photocopier

• Fax machine

• Individual lockers

• Power generator

Infusion area (day clinic)

Independent biological sample preparation area

Central oxygen supply

Crash cart

Infusion pumps

Six infusion recliners

Individual music

TV with cable connection

Handicapped WC

Agreement with mobile coronary care unit

Bone densitometry

Radiology

Biological sample

extraction,

processing and

storing area

Pharmacy Restricted access

Refrigerators and freezer -20º

(-4 ºF)

Controlled and constant room

temperature

Data logger with

programmable readings and

Remote temperature change

warning

Biosefty gabinet

Laminar flow

Auditorium • Central air conditioning

• Seating capacity: 80

• Multimedia availability

General Six medical office

Confortable waiting room

Art gallery

Central air conditioned

Wi-fi

Future We are working together with an

architect in a new front

In-house advertising and books

Monthly meeting with patients

and voluteers in our auditorium

Media meeting and lectures

Performance 2011

Status Feasib. Regulat. Started

65 18 20

0

10

20

30

40

50

60

70

feasib. regulatory started

Biotechnology projects:

novel receptor in the

pathogenesis

of rheumatoid arthritis

CER institute SWOT analysis

Strengths

Trained human resources

Adequate infrastructure

Professional management

Access to a significant number of patients

Appropriate location

Weaknesses Delayed growth (Example:

computerized medical records, more

square feet, etc)

Medical issues: difficult to switch

MD from assistance medicine to

research Medicine

We need to increase illness data

base

Oppotunities Latin America is positioned as a high potential clinical

research region

Argentina has a strong

research training offer

Relatively cheaper than other regions

(90%) Top ten CROs and top five big pharma

are located in Argentina

Regulations with a trend towards international harmonization

Adequate social and political perception

of clinical research

Threats

New regulation of an old law in the

Province of Buenos Aires

Misinformation about the new

regulation of the law.

We are facing one year of inflation

Working in LatAm Established presence in a region with a growing population of 600

million spread across 21 countries

74% of the population lives in Brazil, Mexico, Colombia and Argentina

Access to treatment-naïve patients in many different indications

Higher compliance and retention rates among clinical trial patients

Similar disease profile to North America and Europe, with complicated diseases such as hepatitis, tissue infection and HIV; age-related chronic diseases such as cancer, diabetes, and rheumatoid arthritis; tropical diseases; and infectious diseases

Medical professionals receive training locally as well as in the EU and United States, and are knowledgeable of ICH GCP guidelines

Thank you

Jorge Velasco Zamora