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April 2011

April 2011. Opera Contract Research Organization. Opera CRO: Company profile. C.R.O. 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)

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April 2011

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  1. April 2011 Opera Contract Research Organization

  2. Opera CRO: Company profile C.R.O. • 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

  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.

  4. Opera Team C.R.O. Medical Director Dr. Dionisio Franco Barattini Scientific Director Dr. Laura Michellini Administrative Director Dr. Enrico Serafini

  5. Opera Team 2 Scientific Directors 1 Quality AssuranceResponsible 4 Project Managers 11 Clinical Research Associates 3 Start-upManagers 2 Statisticians 2 Data Managers 1 Laboratory Biologist 3 Clinical Research Assistants 2 AdministrationAssistants C.R.O.

  6. Clinical Trials in the last 12 months Sponsor - Pharmaceutical Companies C.R.O. • Therapeutic Area: • CNS • Oncology • InfectiveDisease • Ophthalmology • Rheumatology • Psychiatry • Vaccines • Medical Devices

  7. Opera Clients • Opera’s Clientsover 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.

  8. Opera Clients (Non Profit) • Opera’s Clientsover 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.

  9. Clinical Activity I • Opera isable to carry out: • Phase I-IV Clinical Trials sponsorizedbyPharmaceuticalCompanies • EpidemiologicalStudies • Specific Clinical Trials for Scientific Associations • Clinical Trials for Medical Devices C.R.O.

  10. Clinical Activity II • Clinical taskswhich can beperformed in accordance with the study requirements • Clinical SitesEvaluation and Selection • Ethical and Administrative Procedures for Trial approval • Management of Clinical DocumentationforHealthAuthoritiesapproval • Writing and Printing of Protocol and CRFs • Clinical Trial Management (Monitoring Visits: pre-study, initial, interim and closurevisit) • Project Management • Investigator Meeting • Clinical DocumentationCentralizedArchiving • Data Management • Statistical Analysis • Medical Writing • Training (forInvestigators, Clinical Monitors and Project Leaders) C.R.O.

  11. Areas where Clinical Trials have been carried out C.R.O. WEST EUROPE Area coveredby CRA based in Genoa, Rome and Milano EAST EUROPE Area coveredby CRA based in Bucharest BRAZIL Area coveredby CRA based in São Paulo MIDDLE EAST Area coveredby CRA based in Tel Aviv

  12. Collaborations C.R.O. • BioengineeringDepartment, University of Genoa for the Development of Medical and Clinical Devices • Linkverse (Rome) for the development of systemsforCapturing and transmittingdigitalimmages in clinical trials trials (ie MR) • PHSE (Milan) courierdedicated to biologicalsamples • Laboraf (Milan) Central Laboratory San Raffaele Hospital

  13. Quality C.R.O. COMPANY’S SYSTEM AUDIT BY SPONSOR TRIAL SITES INTERNAL QUALITY SYSTEM (SOP, QA) ISO 9001 : 2000 (Quality management System) SA - 8000 : 2001 (Social Accountability)

  14. Our most important resource is our personnel • ll Clinical Personnel holdmedical or scientificdegree • Eachyear Opera invests in additional training to • keepits Staff updated with the current clinical trial • regulations • Clinical training coursesprovidedby Opera to its Staff: • ACRP Courses • SSFA Courses • Masters (University of Milan and Rome) • Post-DegreeCourses (University of Pavia) • Opera InternalCourse, 360 hoursfor a beginning Clinical Research Associate • Opera InternalCourse, 80 hoursfor a intermediate Clinical Research Associate C.R.O.

  15. C.R.O. Opera Srl Contract Research OrganizationVia Sampierdarena 33/216149 Genoa; Italyinfo@operacro.comphone: +39 010 469 9623fax: +39 010 659 1120www.operacro.com Thanks for your kind attention

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