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Contract Research Organization “Building clinical research with you”

Zeta Research contract research organisation clinical studies

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cro4Q is the Zeta Research's 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. cro4Q offers complete service that follow experiments, clinical and pharmaceutical researches in the following sectors: medicine, biomedicine, biotechnology and medical devices. Quality support and tools are offered to the client: methodological and normative adequacy, protocol design, biostatistical services for protocol (SAP), data management, statistical analysis, medical writing and reporting.

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  • 1. Building clinical research with you Contract Research Organization
  • 2. 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. Statistical and methodological consulting 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 Zeta Research offers a custom-made Clinical Data Management, according to the clients needs. Data collection through CRF can be either on paper, or on line (web). For every study, a dedicated web site is provided for patients registration, general monitoring, randomization and adverse events management 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 postmarketing evaluation of effectiveness and security (product commonly used in the clinical practice). 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.
  • 3. Planning and management of observational/experimental clinical studies of devices/drugs 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, Clinical Data Management and Medical Writing: data collection & data entry, documentation for Ethics Committees (EC). CRF and e-CRF processing, Trial and Site Management and Monitoring: data validation and verification, site recruitment, data transfer and codification, start-up activity , data monitoring, ethics committees: authorization requests and management, statistical analysis, administrative authorizations, start-up and monitoring of on-site and remote clinical experimentations, monitoring, study reporting, scientific posters and paper. process control and follow-up. Medical writing: abstracts, scientific papers, reviews, presentation tools for conferences 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. Surveys for the medical sector 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. Your best partner for Data Intelligence & Statistical Solution
  • 4. Articles and Congresses 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, UK12-15 May 2013 Experimental Biology 2013Boston, USA20-24 April 2013 30th Annual Scientific Meeting of Obesity Society : Obesity 2012 San Antonio, Texas, USA20-24 September 2012 ESPO AMSTERDAM, 11th International Congress of the European Society of Pediatric OtorhinolaryngologyAmsterdam, Holland20-23 May 2012 19th European Congress on Obesity ECO-2012-Lyon, France9-12 May 2012 Word Nutrition, Knowledge Policy ActionRio de Janeiro, Brazil27-30 April 2012 Experimental Biology 2012San Diego, USA21-25 April 2012 OBESITY 2011Orlando, USA1-5 October 2011 EUROSAFE 2011Budapest, 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 - 812 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, Sweden28 June 1 July 2009 XIX WORLD CONGRESS OF OTO-RHINO-LARYNGOLOGY - So 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 Kong9 March 2011 The Hong Kong International Workshop on Nutritional Profiles - Hong Kong26 February 2010 Workshop Prevencion de accidentes de asfixia en nios: una practica fundamental para la comunidad latinoamericana - Rosario Argentina1 September 2012 Workshop Preveno de acidentes de asfixia em crianas: um papel fundamental a desempenhar para a comunidade LatinoAmericanaSo Paulo Brazil 3 September 2012 Workshop Obesidade infantil na perspectiva Latino Americana -Brasilia- Brazil 20 November 2012 Data security Every year the company invests on new security systems aiming to guarantee the utmost care and discretion of the information we possess. The servers 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. BUILDING SCIENCE WITH YOU N 50 100 10601 REGISTERED AND OPERATIVE OFFICE: Via Caccia, 8 34129 Trieste, Italy www.zetaresearch.eu P.I. e C.F. : 01028800322 TEL. E FAX: +39 040 35 89 80