Zeta Research offers a complete service that follows clinical and pharmaceutical research in the following sectors: medicine, biomedicine, nutrition, biotechnology, and medical devices.
Clinical planning and management - Administrative authorizations; - Cost-efficiency and risk-benefit analysis; - Documentation for Ethics Committees (EC); - Methodological and normative adequacy; - Notification to the Competent Authorities; - Process control and follow-up; - Protocol drafting; - Research planning; - Site recuitment; - Start-up clinical experimentations; - Submission to the Ethics Committees; - Treatment allocation.
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.
Medical writing and reporting - Development Safety Update Report (DSUR) drafting; - Scientific papers; - Scientific posters; - Study reporting; - 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 post-marketing evaluation of effectiveness and security (product commonly used in the clinical practice).