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Clinical Research Unit 4- Data management

TEF-Health Service
Physical Consulting
Pricing/Discount Options: Call #2
Unique Identifier: 25e0cfe3-89b1-4f75-86f1-04f45fac1112

Service Description

Overview

Design and development of a Case Report Form (CRF or e-CRF) tailored to the specific requirements of the clinical investigation. The service includes the identification and structuring of the data to be collected, ensuring alignment with the Clinical Investigation Plan, study objectives, endpoints, and statistical analysis requirements. The CRF/e-CRF will be designed to facilitate accurate, consistent, and efficient data collection at clinical sites while supporting data quality and traceability throughout the study.

How can the service help you?

The service helps SMEs ensure high-quality and consistent data collection throughout their clinical investigation. A well-designed CRF/e-CRF facilitates data collection at clinical sites, supports data quality and traceability, and ensures that the data collected are aligned with the study objectives, endpoints, and statistical analysis requirements.

How will the service be delivered?

The service can be delivered remotely through meetings with the data managers from CHUGA.

Technical details

The work will be conducted in accordance with

  • ICH Guideline for Good Clinical Practice (GCP) E6(R3)
  • EU regulation MDR 2017/745
  • ISO 14155:2026 standard.

Service customization

A clinical investigation plan (CIP) must have been validated in advance.

Keywords: CRF eCRF
Service categories: 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
Provider Logo

Provider & Contact

Provider Organisation Centre Hospitalier Universitaire De Grenoble (CHUGA)
Provider Country France
Ask about this service
Billing: per project
Full Price 6000–15000 EUR
Reduced Price 4000–10000 EUR
Pricing Detail

Prices are subject to change and are indicative only. The final price will be determined by a quote based on SME's needs, and it wil be validated by the contract between the service provider and the applicant.

Operational Details

Service Inputs Clinical Investigation protocol, Data monitoring plan, statistical analysis plan…
Service Outputs Case Report Form (CRF or e-CRF)
Service Standards
  • EU Regulation 2017/745
  • Good Clinical Practices
  • ISO 14155

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