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Opera: presentation December, 10th 2009

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Presentation on theme: "Opera: presentation December, 10th 2009"— Presentation transcript:

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:

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)

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

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