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Opera: presentation December, 10 th 2009. Opera CRO: Company profile Opera is a Contract Research Organization founded in 1995. Its offices are in Genoa,

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Presentation on theme: "Opera: presentation December, 10 th 2009. Opera CRO: Company profile Opera is a Contract Research Organization founded in 1995. Its offices are in Genoa,"— Presentation transcript:

1 Opera: presentation December, 10 th 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 Management 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 Saluteof Italian Ministry of Health Offices: - Genoa (Headquarters) - Genoa (Headquarters) - Rome - Rome - Bucharest - Bucharest 2 partners

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

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

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

7 Clinical Trials in Central Nervous System Public Institutions as Sponsor (no profit studies) 12 months Pathology Center No. Subject No. Sponsor Parkinson10100Limpe Onlus Multiple Sclerosis1242 Università degli Studi di Bari Multiple Sclerosis 1442 Università degli Studi di Roma La Sapienza Multiple Sclerosis 20100Fondazione San Raffaele Monte Tabor, Milano Multiple Sclerosis 458 Università degli Studi di Napoli Federico II

8 Operas Partners Operas partners over the last 12 months: ABBOTT Spa ABBOTT Spa ASTRAZENECA Spa ASTRAZENECA Spa CYATHUS GmbH CYATHUS GmbH FIDIA FARMACEUTICI Spa FIDIA FARMACEUTICI Spa IBI Spa IBI Spa MERCKSERONO SA MERCKSERONO SA VALEANT Spa 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 Phase I, II, III and IV Studies sponsorized by Pharmaceutical Companies Epidemiological Studies Epidemiological Studies Specific studies for Scientific Associations 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 Clinical Centers Evaluation and Selection Ethical and Administrative Procedures for study approval Ethical and Administrative Procedures for study approval Management of Clinical Documentation for Health Authorities approval Management of Clinical Documentation for Health Authorities approval Writing and Printing of Protocol and CRFs Writing and Printing of Protocol and CRFs Clinical Trial Management (Monitoring Visits: pre-study, initial, interim and closure visit) Clinical Trial Management (Monitoring Visits: pre-study, initial, interim and closure visit) Project Management Project Management Investigator Meeting Investigator Meeting Clinical Documentation Centralized Archiving Clinical Documentation Centralized Archiving Data Management Data Management Statistical Analysis Statistical Analysis Medical Writing Medical Writing Training (for Investigators, Clinical Monitors and Project Leaders) Training (for Investigators, Clinical Monitors and Project Leaders) Communication (Web Sites, Newsletter and Graphic) 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 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) Dilogix (Rome) for the development of systems for capturing and transmitting digital photographs in trials (ie MR)

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

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 ACRP Courses SSFA Courses SSFA Courses Masters (University of Milan and Rome) Masters (University of Milan and Rome) Post-Degree Courses (University of Pavia ) Post-Degree Courses (University of Pavia ) Opera Internal Course, 360 hours for a beginning Clinical Research Associate Opera Internal Course, 360 hours for a beginning Clinical Research Associate Opera Internal Course, 80 hours for a intermediate Clinical Research Associate Opera Internal Course, 80 hours for a intermediate Clinical Research Associate

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


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