CER Medical Institute is a private organization dedicated to the prevention, diagnosis, treatment and research of prevalent diseases.

2. Jorge Velasco Zamora
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)

5. 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

6. 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)

7. 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

8. 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.

9. 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

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

11. Trained researchers in
 Onconlogy
 Rheumatology
 Osteology
 Gastroenterology
 Cardiology
 Infectology
 Neurology
 Psychiatry
(8 researchers have masters
in clinical trials)

12. 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

13. 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)

14. 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

15. 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

16. Biological sample
extraction,
processing and
storing area
Radiology
Bone densitometry

17. 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

18. Auditorium
• Central air conditioning
• Seating capacity: 80
• Multimedia availability
General
 Six medical office
 Confortable waiting room
 Art gallery
 Central air conditioned
 Wi-fi

19. Future
We are working together with an
architect in a new front

20. In-house advertising and books

22. Monthly meeting with patients
and voluteers in our auditorium

23. Media meeting and lectures

24. Performance 2011
Status Feasib. Regulat. Started
65 18 20
70
60
50
40
30
20
10
0
feasib. regulatory started

25. Biotechnology projects:
novel receptor in the
pathogenesis
of rheumatoid arthritis

26. CER institute SWOT analysis
Strengths
Trained human resources
Adequate infrastructure
Professional management
Access to a significant number of patients
Appropriate location

27. 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

28. 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

29. 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

30. 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

31. Thank you
Jorge Velasco Zamora