1. Opera: presentation December, 10th 2009

2. Opera CRO: Company profile
Opera is a Contract Research Organization founded in Its offices are in Genoa, Rome and in Bucharest
Opera works throughout Europe and the Middle East
Opera supports Pharmaceutical Companies in conducting clinical trials from phase I to phase IV
Opera is also involved with the development and validation of Medical Devices
Opera develops and finalizes each contract in accordance with the Project Management methodology

3. 2 Management Dionisio Franco Barattini (CEO) Opera Consulting Srl
Opera is a private company formed by two partners:
Dionisio Franco Barattini (CEO)
Opera Consulting Srl
Opera is legally recognized by Italian law
and is reported as CRO in the “Osservatorio Nazionale della Salute”of Italian Ministry of Health
Offices:
- Genoa (Headquarters)
- Rome
- Bucharest 2
partners

4. Opera’s Staff Medical Director Dott. Dionisio Franco Barattini
Scientific Director Dott.ssa Laura Michellini
Administrative Director Dott. Enrico Serafini

5. 25 18 Opera’s Staff 2 Scientific Directors 1 Quality Assurance Manager
3 Project Manager
9 Clinical Research Associates
2 Statisticians
2 Data Managers
1 Biologist Lab. Manager
3 Clinical Research Assistants
2 Administrative Managers
25 full time personnel
Clinical Research Associates and Project Leaders are full time employees 25 18
people

6. Clinical Trials in the last 12 months Pharmaceutical Companies as Sponsor
Therapeutic Area
Cardiovascular System
Respiratory System .
Endocrinology - Metabolism
Oncology
Neuroscience
Rheumatology
Immunology
Gastroenterology
Dermatology
Medical Devices 12
months

7. Clinical Trials in Central Nervous System Public Institutions as Sponsor (no profit studies)
Pathology Center No. Subject No. Sponsor
Parkinson Limpe Onlus
Multiple Sclerosis Università degli Studi di Bari
Multiple Sclerosis Università degli Studi di Roma “La Sapienza”
Multiple Sclerosis Fondazione San Raffaele Monte Tabor, Milano
Multiple Sclerosis Università degli Studi di Napoli “Federico II” 12
months

8. 12 Opera’s Partners Opera’s partners over the last 12 months:
ABBOTT Spa
ASTRAZENECA Spa
CYATHUS GmbH
FIDIA FARMACEUTICI Spa
IBI Spa
MERCKSERONO SA
VALEANT Spa 12
months

9. Clinical Activity I Opera is able to carry out:
Phase I, II, III and IV Studies sponsorized by Pharmaceutical Companies
Epidemiological Studies
Specific studies for Scientific Associations

10. Clinical Activity II
Clinical tasks which can be performed in accordance with the study requirements
Clinical Centers Evaluation and Selection
Ethical and Administrative Procedures for study approval
Management of Clinical Documentation for Health Authorities approval
Writing and Printing of Protocol and CRFs
Clinical Trial Management (Monitoring Visits: pre-study, initial, interim and closure visit)
Project Management
Investigator Meeting
Clinical Documentation Centralized Archiving
Data Management
Statistical Analysis
Medical Writing
Training (for Investigators, Clinical Monitors and Project Leaders)
Communication (Web Sites, Newsletter and Graphic)

11. Areas where studies have been carried out
WEST EUROPE Areas covered by CRA based in Genoa and in Rome
EAST EUROPE Areas covered by CRA based in Bucharest
MEDDLE EAST Areas covered by CRA based in Tel Aviv

12. Collaborations
Bioingineering Department, University of Genoa for the development of Medical and Clinical Devices
Dilogix (Rome) for the development of systems for capturing and transmitting digital photographs in trials (ie MR)

13. Q Quality AUDIT BY SPONSOR STUDY SITES INTERNAL QUALITY SYSTEM
COMPANY’S SYSTEM
AUDIT BY SPONSOR
STUDY SITES
INTERNAL QUALITY SYSTEM
(SOP, QA)
ISO 9001 : 2000
(Quality management Systems)
SA : 2001
(Social Accountability) Q

14. Our most important resource is our personnel
ll Clinical Personel hold medical or scientific degree
Each year Opera invests in additional training to keep its Staff updated with the current clinical trial metodologies
Clinical training courses provided by Opera to its Staff:
ACRP Courses
SSFA Courses
Masters (University of Milan and Rome)
Post-Degree Courses (University of Pavia )
Opera Internal Course, 360 hours for a beginning Clinical Research Associate
Opera Internal Course, 80 hours for a intermediate Clinical Research Associate

15. Thanks for your kind attention
Presentation by Opera Srl - Communication Department