Clinical Trial design, Clinical Protocol consulting and Statistical support for pediatrics
Service Description
Consulting for designing Clinical Trials in a realistic pediatric environment. Keywords: Ethical commettee documentation; Pediatric environment; Clinical trial roadmap; Statistics; best trial type determination;
Offerings:
Ethics & Regulatory Affairs
Conformity & Compliance (certification, audit, corrective and preventive action, documentation, gap & risk analysis, etc.)
Clinical Investigation Support (clinical studies & trials, coordination, design, feasibility, documentation, compliance, operations support)
Development of conformity evaluation standards, protocols & tools
TEF-Health Use Case Domain:
all
Provider & Contact
Provider Organisation
Istituto Giannina Gaslini (IGG)
Provider Country
Italy
Published Email
davidecangelosi@gaslini.org
Pricing is available to registered users. SMEs receive significant state-aid reductions (GBER) — or, depending on the call, free services during the funded project. Sign in or register to see the price for your organisation.
Sign in or register to see pricingOperational Details
Service Inputs
Technical file of the medical device (intended use, technical specifications, user manual, risk analysis,...)
Service Outputs
Clinical protocol synopsis
Dependencies & Restrictions
AI act; MDR; GDPR
Certification Support
Not applicable
Service Standards
EU Regulation 2017/745
Good Clinical Practise
- EU Regulation 2017/745
- Good Clinical Practise