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)
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
Biological sample extraction, processing and storing area Radiology
Bone densitometry
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
70 60 50 40 30 20 10 0 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