Contract Research Organization

“Building clinical research with you”

Zeta Research joins and supports manufacturers, researchers and institutions in assessing the feasibility of a study and in

building experimental/observational clinical trials.

It also offers solutions for data collection and statistical processing (statistical analysis, production of statistical reports).

Data collection with paper / web support, data entry

Statistical and methodological consulting

For every study, a dedicated web site is provided for

patients registration, general monitoring,

randomization and adverse events management

Zeta Research always guarantees the highest ethical standards and scientific quality of clinical trials, in

compliance with the GCP (Good Clinical Practice) and the SOPs (Standard Operating Procedure) standards.

Thanks to the use of new information system technologies and web services, Zeta Research can manage

clinical trials in many parts of the world, from South America to Asia, always ensuring the quality of collected

data, data monitoring and queries resolution. Furthermore, a qualified team produces rigorous scientific

documentation and report to clearly and concisely present results, matched by the evaluation of their clinical

relevance.

Every stage of internal processes undergoes a thorough quality control to ensure accuracy and consistency of

the processed data.

Zeta Research is a CRO (Contract Research Organization) registered at AIFA (Italian

Medicines Agency) that develops professional researches in the scientific and

statistics field. Since over a decade Zeta Research is offering scientific, technical and

statistics consulting services for the medical and clinical sectors.

Zeta Research follows its clients in every step both in the Pharmaceutical product

and Medical Device planning and developing, and in the building of the clinical

researches.

Quality support and tools are offered to the client: methodological and normative

adequacy, protocol design, study statistical plan, detection tools with ITC solutions,

cost and risk analysis, medical writing and reporting and quality control.

A synergic group of professionals belonging to different fields work in team in order to offer specific replies to the specific

needs of the client.

Technical document writing & management

Zeta Research, according to EU regulatory system, offers a complete service of technical document

writing and management, both for Medical Devices EC marking or medicines registration (Clinical

Evaluation Report, Expertise, Position Paper and Risk Analysis) and for clinical studies and for post-

marketing evaluation of effectiveness and security (product commonly used in the clinical practice).

Zeta Research offers a custom-made Clinical Data Management, according to the

client’s needs. Data collection through CRF can be either on paper, or on line

(web).

Planning and management of

observational/experimental clinical studies of devices/drugs

Zeta Research has a great experience both in the industrial and in the private and in the academic research, and has a wide and rich curriculum in scientific writing of international level.

Zeta Research can easily produce:

scientific abstracts and posters,

papers for international scientific journals,

presentation materials and tools for national/international conferences,

literature reviews and research material,

meta-analysis,

study reports, integrated clinical trials reports.

Your best partner for Data Intelligence & Statistical Solution

Medical writing: abstracts, scientific papers, reviews, presentation tools for conferences

Zeta Research offers high quality telephone survey services for the medical sector. It uses the classic methods of market

research and opinion polls applied to medical sciences service.

Surveys rely on several technical solutions: CATI methodology (Computer Assisted Telephone Interview), CAWI methodology

(Computer A Web Interviewing) , postal or face-to-face interviews, SMS system, web solutions, touch system.

Zeta Research can also develop wider services, including focus group and preparatory researches, to offer multidisciplinary and

structured results, guaranteeing as well reliability and confidentiality.

Surveys for the medical sector

Clinical Planning & Management:

research planning,

methodological and normative adequacy,

protocol design,

statistical plan, sample design and size,

end-point definition,

ITC (Information and Communication Technologies) solutions for randomizing,

treatment allocation,

data collection,

cost-efficiency and risk-benefit analysis,

statistical methodology design,

design and realization of paper CRF (Case Report Form) on paper / electronic support,

documentation for Ethics Committees (EC).

Trial and Site Management and Monitoring:

site recruitment,

start-up activity ,

ethics committees: authorization requests and management,

administrative authorizations,

start-up and monitoring of on-site and remote clinical experimentations,

monitoring,

process control and follow-up.

Clinical Data Management and Medical Writing:

data collection & data entry,

CRF and e-CRF processing,

data validation and verification,

data transfer and codification,

data monitoring,

statistical analysis,

study reporting,

scientific posters and paper.

Articles and Congresses

BUILDING SCIENCE WITH YOU

Data security

Some important events we took part since 2003 by presenting oral presentations and posters or by participating in round table discussions:

20th European Congress on Obesity ECO-2013-Liverpool, UK—12-15 May 2013 Experimental Biology 2013—Boston, USA—20-24 April 2013 30th Annual Scientific Meeting of Obesity Society : Obesity 2012 San Antonio, Texas, USA—20-24 September 2012 ESPO AMSTERDAM, 11th International Congress of the European Society of Pediatric Otorhinolaryngology—Amsterdam, Holland—20-23

May 2012 19th European Congress on Obesity ECO-2012-Lyon, France—9-12 May 2012 Word Nutrition, Knowledge Policy Action—Rio de Janeiro, Brazil—27-30 April 2012 Experimental Biology 2012—San Diego, USA—21-25 April 2012 OBESITY 2011—Orlando, USA—1-5 October 2011 EUROSAFE 2011—Budapest, Hungary - 15-17 June 2011 18th European Congress on Obesity ECO-2011— Istanbul, Turkey - 25-28 May 2011 Experimental Biology 2011- Washingtan, USA - 9-13 April 2011 OBESITY 2010— San Diego, USA - 8—12 October2010 SCT 31 st Annual Meeting— Baltimore, USA, 16-19 May 2010 OBESITY 2009 – Washington, USA, 24-28 October 2009 ESPR 2009 (50° ANNUAL MEETING OF THE EUROPEAN SOCIETY for PEADIATRIC RESEARCH) - Hamburg, Germany 9-12 October 2009 SRA EUROPE 2009 ANNUAL MEETING, From the everyday to the extraordinary: challenges for risk analysis and management - Karlstad,

Sweden—28 June – 1 July 2009 XIX WORLD CONGRESS OF OTO-RHINO-LARYNGOLOGY - São Paulo, Brazil - 1 – 5 June 2009 EAP 2008 (2nd Congress of the European academy of paediatrics) - Nizza, France - 24 – 28 October 2008 SafeKids worldwide 2008 Child injury prevention conference - Washington, USA - 15-18 October 2008 2nd European conference on injury prevention and safety promotion - Paris, France - 9-10 October 2008 OBESITY 2008 - Phoenix, USA - 3 -7 October 2008 Expert meeting on estimating the size of high-risk population - New York City, USA - 3-4 September 2008 2007 Joint Statistical Meeting - Salt Lake City, USA - 29 July – 2 August 2007 2006 Joint Statistical Meeting— Seattle, USA - 6-10 July 2006

Events we organized:

The Hong Kong International Workshop on Multifunctional foods and traditional ingredients: a competitive marriage? - Hong Kong—9 March 2011

The Hong Kong International Workshop on Nutritional Profiles - Hong Kong—26 February 2010 Workshop “Prevencion de accidentes de asfixia en niños: una practica fundamental para la comunidad latinoamericana” - Rosario–

Argentina—1 September 2012 Workshop “Prevenção de acidentes de asfixia em crianças: um papel fundamental a desempenhar para a comunidade Latino-

Americana“—São Paulo– Brazil– 3 September 2012 Workshop “Obesidade infantil na perspectiva Latino Americana” -Brasilia- Brazil– 20 November 2012

N° 50 100 10601

P.I. e C.F. : 01028800322

TEL. E FAX: +39 040 35 89 80

Every year the company invests on new security systems aiming to guarantee the utmost care and discretion of the information

we possess. The server’s management provides a constant monitoring of all activities performed by users, preventing any risk

of data loss or external leak, restricting information to the pool of authenticated users directly involved in the projects. The

servers present in our CED room are continuously monitored by an internal specialized staff that guarantees a programmed up

keeping as well as the full operativeness of our systems.

REGISTERED AND OPERATIVE OFFICE:

Via Caccia, 8 34129 Trieste, Italy

www.zetaresearch.euwww.zetaresearch.eu