ZETA RESEARCH SRL

Company profile

Zeta Research is a CRO (Contract Research Organization) recognized by the AIFA (Italian Drug Agency) for the development of clinical trials (DM of November 15, 2011), operating nationally and internationally. The company offers scientific and statistical consulting services in the medical, clinical and nutritional sectors, in the design, development, and management of clinical, scientific and research projects.

Main products/services

The services offered have the regulatory requirements in the field of pharmacology and medical devices, as well as Nutrition (Groups 1 and 3). Services include: design of the study, drafting of the protocol and CRF (Case Report Form), document management, selection of the Centers, submission to the Ethics Committees, notification to the Competent Authorities, site for web data collection, data management, monitoring by remote and on-site, database cleaning with recoding, statistical data analysis, editing of scientific material.
Online data collection (EDC- Electronic Data Capture) takes place through the use of computer systems validated according to the CSV (Computer System Validation) (Group 2). All services meet the specific regulatory requirements and international guidelines ICH GCP (Good Clinical Practice), Annex 11, CFR part 11 (Code of Federal Regulations), Privacy Policy, and SCDM standards (Society for Clinical Data Management), GCDMP (Good Clinical Data Management Practices) & CDISC (Clinical Data Interchange Standards Consortium). The data collected, in validated databases, can be used for registration or marking of new products or for post-marketing supervision.

Partnerships and collaborations

Multinational Pharmaceutical, Electromedical and Food / Health Organizations, Medical Associations and European Authorities (EFSA). The company is also a partner in consortia with Italian Universities and Institutes for EU Calls.