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Clinical Trial design, Clinical Protocol consulting and Statistical support for pediatrics

Consulting
Unique Identifier: 69047e63-3a4d-47d3-bc9a-19dd8a39f169

Service Description

Our service can provide consulting for designing Clinical Trials in a realistic pediatric environment; Ethical commettee documentation; Pediatric environment; Clinical trial roadmap; Statistics; best trial type determination. Prices are subject to change and are only indicative. The final price will be determined in the contract between the service provider and the applicant.

Offerings: Expert Medical Opinion Scientific & Medical Communication Development of conformity evaluation standards, protocols & tools Clinical Investigation Support (coordination, design, feasibility, documentation,compliance, operations support, etc.)
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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.

Operational Details

Service Inputs Technical file of the medical device (intended use, technical specifications, user manual, risk analysis,...)
Service Outputs Clinical protocol synopsis
Dependencies & Restrictions GDPR;AI Act;MDR;
Service Standards "EU Regulation 2017/745 Good Clinical Practise"
  • EU Regulation 2017/745
  • Good Clinical Practise