1. Contract Research Organization
Opera
Contract Research Organization
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April 2011

2. Opera CRO: Company profile
Opera is a Contract Research Organization founded in 1995.
Offices:
Genoa (Headquarters)
Rome
Milano
Bucharest
Opera is a private company formed by two partners:
Dionisio Franco Barattini (CEO)
Opera Consulting Srl
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3. Opera CRO: Company profile
Opera is Contract Research Organization legally recognized by Italian law and is registered in the “Osservatorio Nazionale della Salute”of Italian Ministry of Health
Opera works throughout Europe, Brazil and Middle East
Opera supports Pharmaceutical Companies in conducting clinical trials from Phase I to Phase IV
Opera is also involved in the development and validation of Medical Devices
Opera develops and finalizes each contract in accordance with the Project Management methodology
C.R.O.
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4. C.R.O. Opera Team Medical Director Dr. Dionisio Franco Barattini
Scientific Director Dr. Laura Michellini
Administrative Director Dr. Enrico Serafini
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5. C.R.O. Opera Team 2 Scientific Directors
1 Quality Assurance Responsible
4 Project Managers
11 Clinical Research Associates
3 Start-up Managers
2 Statisticians
2 Data Managers
1 Laboratory Biologist
3 Clinical Research Assistants
2 Administration Assistants
C.R.O.
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6. C.R.O. Clinical Trials in the last 12 months
Sponsor - Pharmaceutical Companies
C.R.O.
Therapeutic Area:
CNS
Oncology
Infective Disease
Ophthalmology
Rheumatology
Psychiatry
Vaccines
Medical Devices
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7. C.R.O. Opera Clients Opera’s Clients over the last 12 months:
ABBOTT SpA
ASTRAZENECA SpA
CT FARMACEUTICI Srl
CYATHUS GmbH
FARMILA THEA SpA
FIDIA FARMACEUTICI SpA
MERCKSERONO SA
NOVARTIS VACCINES
RICHERPHARMA
C.R.O.
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8. C.R.O. Opera Clients (Non Profit)
Opera’s Clients over the last 12 months:
Istituto Superiore Di Sanità’ (ISS)
Fderazione Italiana Sclerosi Multipla (FISM)
Fondazione IRCCS Istituto Dei Tumori, Milano
Fondazione San Raffaele del Monte Tabor, Milano
Italian Trials In Medical Oncology (ITMO)
Policlinico S. Matteo, Pavia
Ser.T Carpaccio, AUSL Bologna
Vascular Independent Research and Education European Organisation
C.R.O.
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9. C.R.O. Clinical Activity I Opera is able to carry out:
Phase I-IV Clinical Trials sponsorized by Pharmaceutical Companies
Epidemiological Studies
Specific Clinical Trials for Scientific Associations
Clinical Trials for Medical Devices
C.R.O.
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10. C.R.O. Clinical Activity II
Clinical tasks which can be performed in accordance with the study requirements
Clinical Sites Evaluation and Selection
Ethical and Administrative Procedures for Trial 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)
C.R.O.
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11. Areas where Clinical Trials
have been carried out
C.R.O.
WEST EUROPE Area covered by CRA based in Genoa, Rome and Milano
EAST EUROPE Area covered by CRA based in Bucharest
BRAZIL Area covered by CRA based in São Paulo
MIDDLE EAST Area covered by CRA based in Tel Aviv
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12. Collaborations
C.R.O.
Bioengineering Department, University of Genoa for the Development of Medical and Clinical Devices
Linkverse (Rome) for the development of systems for Capturing and transmitting digital immages in clinical trials trials (ie MR)
PHSE (Milan) courier dedicated to biological samples
Laboraf (Milan) Central Laboratory San Raffaele Hospital
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13. C.R.O. Quality AUDIT BY SPONSOR TRIAL SITES INTERNAL QUALITY SYSTEM
COMPANY’S SYSTEM
AUDIT BY SPONSOR
TRIAL SITES
INTERNAL QUALITY SYSTEM
(SOP, QA)
ISO 9001 : 2000
(Quality management System)
SA : 2001
(Social Accountability)
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14. C.R.O. Our most important resource is our personnel
ll Clinical Personnel hold medical or scientific degree
Each year Opera invests in additional training to
keep its Staff updated with the current clinical trial
regulations
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
C.R.O.
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15. Thanks for your kind attention
C.R.O.
Opera Srl Contract Research Organization Via Sampierdarena 33/ Genoa; Italy phone: fax:
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