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Clinical Research Unit 7- Clinical operations monitoring/vigilance

TEF-Health Service
Physical Consulting
Pricing/Discount Options: Call #2
Unique Identifier: b14b84d7-4039-4477-b152-7432822d09ea

Service Description

Overview

Providing comprehensive monitoring and vigilance services throughout the clinical study. Our team supports SMEs in the planning, coordination ensuring that the study is conducted in accordance with the Clinical Investigation Plan (CIP), applicable local regulatory requirements, Good Clinical Practice (GCP) principles, and relevant standards. This service includes monitoring of study and compliance, safety and vigilance activities (adverse events...), identification and management of deviations, and support with regulatory documentation and reporting throughout the study lifecycle

How can the service help you?

The service supports SMEs in the monitoring and vigilance activities of their clinical studies.

How will the service be delivered?

The service can be delivered remotely through meetings with clinical sites and/or SME. Study monitoring is preferably conducted on-site but can also be performed remotely.

Technical details

The tasks will be carried out in accordance with the specifications of the Clinical Investigation Plan (CIP) and particularly monitoring and data management plan approved by the SME. 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

The service can be customized according to the SME’s specific needs. The Clinical Investigation Plan (CIP) must have been approved by the relevant local regulatory authorities and the Ethics Committee.

Keywords: clinical study monitoring vigilance
Service categories: Clinical Investigation Support (clinical studies & trials, coordination, design, feasibility, documentation, compliance, operations support, etc.) Testing Facility Real-World (ER, OR, ICU, office, ambulance, ward, patient home, etc.) Clinical Investigation Support (coordination, design, feasibility, documentation,compliance, operations support, etc.)
TEF-Health Use Case Domain: all
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Provider & Contact

Provider Organisation Centre Hospitalier Universitaire De Grenoble (CHUGA)
Provider Country France
Ask about this service
Billing: per hour
Full Price 55–135 EUR
Reduced Price 45–135 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 protocol approved by regulatory authorities (Ethical committee, ANSM)
Service Outputs data from the clinical study monitored and adverse events tracked
Service Standards
  • EU Regulation 2017/745
  • Good Clinical Practices
  • ISO 14155

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