Presentation Cir Ec
9
1 CiRec A clinical site dedicated exclusively to industry- sponsored trials Because your timelines matter and patient recruitment is a global challenge we have created
-
Upload
elcoloortiz -
Category
Documents
-
view
570 -
download
0
Transcript of Presentation Cir Ec
1
CiRec A clinical site dedicated
exclusively to industry-
sponsored trials
Because your timelines matter and patient recruitment is a global challenge we have created
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
3 Located in Rosario, the third largest city of Argentina with a population of 1,2 M inhabitants
CiRec Location
4
A state of the art intelligent building for ambulatory medicine
Trials at CiRec and ANMAT • CiRec is the clinical trials unit at CiR a 10-
storey medical building in Rosario
• CiR is one of the largest ambulatory clinics in Rosario with over 100 physicians in 70 offices 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
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
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)
Neurology: (2)
Urology: (5)
Traumatology: (5)
Between 300-500 ambulatory visits a day
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
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
9
CiRec Contacts Lic. Guillermo Ortiz, COO
+54 9 341 503 8610
Dr. Sergio Fuster, Medical Director
0810 7770 CiR (247) int.704
Dr. Juana Corte, Study Coordinator
0810 7770 CiR (247) int.705
www.consultoriosintegrados.org
