Zeta Research is a CRO (Contract Research Organization) self-certified at the Italian Pharmaceutical Agency (AIFA) for statistical analysis and management of data from interventional drug studies, according to DM 15 November 2011.
The data obtained by the internal procedures implemented by Zeta Research meet the specific regulatory requirements and international guidelines (application of Good Clinical Practices, Annex 11, Code of Federal Regulations Title 21 part 11, Privacy Regulation and standards SCDM, GCDMP e CDISC).
Data Collection & Data Management
- Breaking the blind;
- Data Collection;
- Data Entry;
- Design and realization of Case Rerport Form;
- ITC (Information and Communication Technologies) solution for randomizing;
- Management randomization;
- Medical coding;
- Transfer and data encryption;
- Validation and verification of data.
Statistical and Metodological Consulting
- Endpoints identification and quantification;
- Sample design and size;
- Statistical analysis;
- Statistical Analysis Plan;
- Statistical Metodology design;
- Statistics sections for the clinical study protocol;
- Study design choice.