Dear Colleague, The purpose of this short presentation is to let you know that we have now a dedicated Division to execute clinical trials in Rosario, Argentina. CiR (Consultorios Integrados Rosario) is a state of the art facility with 70 doctor offices in which specialists and generalists work every day. CiRec (CiR Estudios Clinicos) offers GCP-trained coordinators and physicians who have conducted industry-sponsored and ANMAT-approved trials in the past. In addition, we have a steering committee who meets upon demand to tackle issues related to patient recruitment and we have quick access to Ethics Committees. We know how important rapid patient recruitment is, but in a strict safety environment where data are collected with high quality. If you have any questions or would like to arrange an official visit for a tour of the facilities please contact me directly. Many thanks Guillermo Ortiz

1. Because your timelines matter and patient recruitment is a global challenge we have created
CiRec
A clinical site dedicated
exclusively to industry-
sponsored trials
1

2. CiRec Background
 Location of CiRec
 History of trials and ANMAT certifications
 Clinical trials dedicated team
 Specialties and Patients
 Ethics Committee
 Advisory Board and Steering Committee
 Contact
2

3. CiRec Location
Located in Rosario, the third largest city of Argentina with a population of 1,2 M inhabitants
3

4. Trials at CiRec and ANMAT
• CiRec is the clinical trials unit at CiR a 10-
storey medical building in Rosario
 A state of the art intelligent
• CiR is one of the largest ambulatory clinics in building for ambulatory
Rosario with over 100 physicians in 70 offices medicine
and endoscopy suites
• Industry trials conducted under GCP were
originally in the GI space:
• - “A Randomized Double-Blind parallel Study of Rabeprazole
Extended-Release 50mg versus Esomeprazole 40mg for Healing
and symptomatic Relief of Moderate to Severe Erosive
Gastroesophageal Reflux Disease (GERD)” 2008
- “Comparison of the Efficacy and safety of Infliximab,as
Monotherapy or in Combination with Azathioprine, Versus
Azathioprine Monotherapy in Moderate to Severe Active
Ulcerative Colitis (Part 1)
Comparison of maintenance Versus Intermittetnt Infliximab
Treatment in Maintaining remission : A Follow-up of Efficacy
and Safety (Part 2)” 2008
• ANMAT (Argentina’s FDA) certified the site
on : December 2008
• Now CiR has expanded to many other
medical specialties
4

5. CiRec clinical trials team
 More than 100 physicians recruit subjects into
protocols
 GCP trained study coordinators
 Medical Director
 Ethics Committee
 Dedicated unit with pharmacy, local
laboratories, offices and archives for industry-
sponsored trials
 Own SOPs or sponsor SOPs are used
5

6. Medical Specialties (17) at CiRec
 Internal Medicine (14)
 Pediatrics (6 )
 Oncology (4)
 Cardiology: (6)
 Gastroenterology (7)
 Pulmonary (1)
 Gyn/Ob (12)
 Nutrition: (2)
 Allergy: (1)
 Surgery: (11)
 Dermatology: (5)
 Endocrinology: (7)
 Phlebology: (1)
 Hematology: (2) Between 300-500 ambulatory visits a day
 Neurology: (2)
 Urology: (5)
 Traumatology: (5)
6

7. Ethics Committees
 We use an independent external Ethics
Committee :
- CECOR
President: DR. Daniel Sarcuno, MD.
 We have our own Ethics Committee that meets
once a week
7

8. Advisory Board and Steering
Committee
 Meets on demand
 Tackles problems with recruitment and quality
 Seasoned industry experienced individuals
 All under CDA
 Local and International members
8

9. CiRec Contacts
 Lic. Guillermo Ortiz, COO
+54 9 341 503 8610
cirec@consultoriosintegrados.org
 Dr. Sergio Fuster, Medical Director
0810 7770 CiR (247) int.704
sergio.fuster@consultoriosintegrados.org
 Dr. Juana Corte, Study Coordinator
0810 7770 CiR (247) int.705
juanacorte@consultoriosintegrados.org
www.consultoriosintegrados.org
9