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Contract Research Organization

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Presentation on theme: "Contract Research Organization"— Presentation transcript:

1 Contract Research Organization
Opera Contract Research Organization Note: 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 Note:

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. Note:

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

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. Note:

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 Note:

7 C.R.O. Opera Clients Opera’s Clients over the last 12 months:

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. Note:

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. Note:

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. Note:

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 Note:

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 Note:

COMPANY’S SYSTEM AUDIT BY SPONSOR TRIAL SITES INTERNAL QUALITY SYSTEM (SOP, QA) ISO 9001 : 2000 (Quality management System) SA : 2001 (Social Accountability) Note:

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. Note:

15 Thanks for your kind attention
C.R.O. Opera Srl Contract Research Organization Via Sampierdarena 33/ Genoa; Italy phone: fax: Note:

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