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Opera: presentation December, 10 th 200 9

Opera: presentation December, 10 th 200 9. Opera CRO: Company profile. Opera is a Contract Research Organization founded in 1995. Its offices are in Genoa, Rome and in Bucharest Opera works throughout Europe and the Middle East

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Opera: presentation December, 10 th 200 9

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  1. Opera:presentationDecember, 10th 2009

  2. Opera CRO: Company profile Opera is a ContractResearchOrganizationfounded in 1995. Itsoffices are in Genoa, Rome and in Bucharest Opera worksthroughoutEurope and the Middle East Opera supportsPharmaceuticalCompanies in conductingclinicaltrialsfromphase I tophase IV Opera isalsoinvolvedwith the development and validationofMedicalDevices Opera develops and finalizeseachcontract in accordancewith the Project Management methodology

  3. Management 2 Opera is a private company formedbytwopartners: Dionisio Franco Barattini (CEO) Opera Consulting Srl Opera islegallyrecognizedbyItalianlaw and isreportedas CRO in the “Osservatorio Nazionale della Salute”ofItalianMinistryofHealth Offices: - Genoa (Headquarters) - Rome - Bucharest partners

  4. Opera’s Staff MedicalDirector Dott. Dionisio Franco Barattini ScientificDirector Dott.ssa Laura Michellini AdministrativeDirector Dott. Enrico Serafini

  5. Opera’s Staff 2 ScientificDirectors 1 QualityAssurance Manager 3 Project Manager 9 ClinicalResearchAssociates 2 Statisticians 2 Data Managers 1 BiologistLab. Manager 3 ClinicalResearchAssistants 2 AdministrativeManagers 25 full time personnel Clinical Research Associates and Project Leaders are full time employees 25 18 people

  6. ClinicalTrials in the last 12 monthsPharmaceuticalCompaniesas Sponsor • Therapeutic Area • Cardiovascular System • Respiratory System . • Endocrinology - Metabolism • Oncology • Neuroscience • Rheumatology • Immunology • Gastroenterology • Dermatology • MedicalDevices 12 months

  7. ClinicalTrials in CentralNervous SystemPublic Institutionsas Sponsor (no profit studies) Pathology Center No. Subject No. Sponsor Parkinson 10 100 Limpe Onlus Multiple Sclerosis 12 42 Università degli Studi di Bari Multiple Sclerosis 14 42 Università degli Studi di Roma “La Sapienza” Multiple Sclerosis 20 100 Fondazione San Raffaele Monte Tabor, Milano Multiple Sclerosis 4 58 Università degli Studi di Napoli “Federico II” 12 months

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

  9. ClinicalActivity I • Opera isabletocarry out: • Phase I, II, III and IV StudiessponsorizedbyPharmaceuticalCompanies • EpidemiologicalStudies • SpecificstudiesforScientificAssociations

  10. ClinicalActivity II • Clinicaltaskswhich can beperformed in accordancewith the studyrequirements • ClinicalCentersEvaluation and Selection • Ethical and AdministrativeProceduresforstudyapproval • Management ofClinicalDocumentationforHealthAuthoritiesapproval • Writing and PrintingofProtocol and CRFs • Clinical Trial Management (MonitoringVisits: pre-study, initial, interim and closurevisit) • Project Management • Investigator Meeting • ClinicalDocumentationCentralizedArchiving • Data Management • StatisticalAnalysis • MedicalWriting • Training (forInvestigators, ClinicalMonitors and Project Leaders) • Communication (Web Sites, Newsletter and Graphic)

  11. Areaswherestudieshavebeencarried out WEST EUROPE Areascoveredby CRA based in Genoa and in Rome EAST EUROPE Areascoveredby CRA based in Bucharest MEDDLE EAST Areascoveredby CRA based in Tel Aviv

  12. Collaborations BioingineeringDepartment, Universityof Genoa for the developmentofMedical and ClinicalDevices Dilogix (Rome) for the developmentofsystemsforcapturing and transmittingdigitalphotographs in trials (ie MR)

  13. Quality COMPANY’S SYSTEM AUDIT BY SPONSOR STUDY SITES INTERNAL QUALITY SYSTEM (SOP, QA) ISO 9001 : 2000 (Quality management Systems) SA - 8000 : 2001 (Social Accountability) Q

  14. Ourmostimportantresourceisourpersonnel • llClinicalPersonelholdmedical or scientificdegree • Eachyear Opera invests in additional training tokeepits Staff updatedwith the currentclinicaltrial metodologies • Clinicaltraining coursesprovidedby Opera toits Staff: • ACRP Courses • SSFA Courses • Masters (Universityof Milan and Rome) • Post-DegreeCourses (Universityof Pavia ) • Opera InternalCourse, 360 hoursfor a beginningClinicalResearch Associate • Opera InternalCourse, 80 hoursfor a intermediate ClinicalResearch Associate

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

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