OperaOperaContract Research Contract Research

OrganizationOrganization

April 2011

Opera CRO: Company profileC

.R.O. Opera is a Contract Research Organization

founded in 1995.

Offices:Genoa (Headquarters) RomeMilanoBucharest

Opera is a private company formed by two partners: Dionisio Franco Barattini (CEO) Opera Consulting Srl

Opera CRO: Company profileC

.R.O.

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

Opera TeamC

.R.O.

Medical Director Dr. Dionisio Franco Barattini

Scientific Director Dr. Laura Michellini

Administrative Director Dr. Enrico Serafini

Opera TeamC

.R.O.

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

Clinical Trials in the last 12 monthsSponsor - Pharmaceutical Companies

C.R

.O.

Therapeutic Area:

CNS

Oncology

Infective Disease

Ophthalmology

Rheumatology

Psychiatry

Vaccines

Medical Devices

Opera ClientsC

.R.O.

Opera’s Clients over the last 12 months:

ABBOTT SpA

ASTRAZENECA SpA

CT FARMACEUTICI Srl

CYATHUS GmbH

FARMILA THEA SpA

FIDIA FARMACEUTICI SpA

MERCKSERONO SA

NOVARTIS VACCINES

RICHERPHARMA

Opera Clients (Non Profit)C

.R.O.

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

Clinical Activity IC

.R.O.

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

Clinical Activity IIC

.R.O.

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)

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

CollaborationsC

.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

QualityC

.R.O.

COMPANY’S SYSTEMAUDIT BY SPONSOR

TRIAL SITES

INTERNAL QUALITY SYSTEM(SOP, QA)

ISO 9001 : 2000(Quality management System)

SA - 8000 : 2001 (Social Accountability)

Our most important resource is our personnel

C.R

.O.

ll Clinical Personnel hold medical or scientific degree

Each year Opera invests in additional training tokeep its Staff updated with the current clinical trialregulations

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.

Opera Srl Contract Research OrganizationVia Sampierdarena 33/2

16149 Genoa; Italyinfo@operacro.com

phone: +39 010 469 9623fax: +39 010 659 1120

www.operacro.com

Thanks for your kind attention