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Clinical Research Unit 3- Medical writing of clinical study documentation

TEF-Health Service
Physical Consulting
Pricing/Discount Options: Call #2
Unique Identifier: 9eecb9eb-5e1c-4cbf-9ac0-7ee7e493998f

Service Description

Overview

Providing comprehensive support in the preparation of the documentation required for clinical investigation and regulatory submissions. This service includes the drafting of key clinical documents, such as the Clinical Investigation Plan (CIP) and Patient Informed Consent documentation, in accordance with applicable regulatory requirements and the specific needs of the study. The service also includes support with the preparation and review of the technical documentation required for the regulatory submission, including the Investigator’s Brochure, where applicable. Technical documentation remains under the manufacturer’s responsibility, while our team provides scientific and clinical expertise to support its preparation, ensure consistency across documents, and facilitate the regulatory submission process.

How can the service help you?

The service provides SMEs with access to specialized medical, regulatory, and scientific expertise for the preparation of documentation required for clinical investigations and regulatory submissions. It ensures that documents are scientifically sound, consistent, and aligned with applicable regulatory requirements, while reducing the workload associated with their preparation and review. The service is tailored to the specific needs of the SME and the clinical investigation.

How will the service be delivered?

The service can be delivered remotely. A healthcare professional must be involved.

Technical details

The work will be conducted in accordance with

  • the ICH Guideline for Good Clinical Practice (GCP) E6(R3)
  • EU regulation MDR 2017/745
  • guidelines MDCG 2024-3, MDCG 2024-5
  • ISO 14155:2026 standard

Service customization

The documentation can be tailored to the specific requirements of the SME, the clinical investigation, and the applicable regulatory framework.

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 15000–20000 EUR
Reduced Price 10000–18000 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 Synopsis
Service Outputs - Clinical Investigation Plan (CIP) - Patient Informed Consent - Investigator brochure - Monitoring plan - Statistical analysis plan - (…)
Service Standards
  • EU Regulation 2017/745
  • Good Clinical Practices
  • ISO 14155
  • mdcg 2024-3
  • mdcg 2024-5

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