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Clinical Research Services - Medical writing

Physical
Unique Identifier: c0091fe5-4ab7-466c-84cf-ea95f111cc17

Service Description

Creation and provision of essential documents required for clinical investigation implementation and performance: investigation protocol, synopis, Informed Consent Form, investigation agreement, logs, etc. Implementation of clinical investigation files : site master file, investigation sponsor files, etc.

HUmani can provide this service à la carte or with full sponsor role.

Offerings: Testing Clinical (investigation, trial, etc.) Clinical Investigation Support (clinical studies & trials, coordination, design, feasibility, documentation, compliance, operations support, etc.)
TEF-Health Use Case Domain: all
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Provider & Contact

Provider Organisation HUMANI SC - Hospital network (HUMANI)
Provider Country Belgium
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Billing: per hour
Full Price €70–265 EUR
Reduced Price €54–202 EUR

Operational Details

Service Inputs Medical device documentation; Feasability report; Preliminary synopis; Project draft; Clinical investigation protocol
Service Outputs Essential documents : clinical investigation protocol; informed consent form; Logs; etc; Clinical investigation files (site master file; investigation sponsor file); clinical investigation agreement draft
Dependencies & Restrictions  
Certification Support  
Service Standards
  • Artificial Intelligence Act
  • Belgian national laws
  • EU regulations: Medical Devices
  • GDPR
  • IATA
  • International regulations: Good Clinical Practice (ICH-GCP)
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