Anticipation of all ethical and regulatory constraints, at the national and European levels, to guarantee that the clinical investigation complies strictly with the legal framework:

• Preparation of regulatory submission documents
• Communication with official agencies
• Insurance, etc.

We can customise and design CRFs and e-CRFs to optimise the quality of the data collection in line with the study aims:

• Draw up specifications in collaboration with the sponsor and the investigator to ensure optimum customisation of the e-CRF or CRF
• Team training
• Data archiving

Reporting to one of our clinical project managers, we will perform the operational management of your study, from organising the set-up of the investigating centres to the study close-out and the promotion of the results:

•     Opening of each centre
•     Staff training and co-ordination
•     Study close-out
•     Interim and final reports

On-site and remote monitoring

Monitoring, including on-site and/or remote visits, adapted to the specific study monitoring plan to:

• Ensure that the rights of individuals are respected, particularly with regard to the anonymity of the information collected
• Guarantee the reliability and traceability of data
• Ensure that the study is conducted correctly and complies with the protocol, good practice, and applicable clinical regulations
• Anticipate and quickly identify problems to avoid critical issues with study compliance

IC@dom is a contract research organisation (CRO) authorised by the Agence Régionale de Santé Auvergne-Rhône-Alpes to carry out research involving human subjects. This allows us to evaluate individuals who are suitable for research in their real-life environments: at home.

Here are a few examples of the services we provide within the home:

• Electronic consent signing (e-consent)
• Technical procedures at home (blood tests, polysomnography, actimetry, etc.)
• Follow-up home visits by nurses, physiotherapists, technicians, etc.
• Telephone follow-up
• Logistical management of equipment: storage, maintenance, disinfection, etc.

To guarantee the monitoring and safety of the study by collecting all events and, if necessary, reporting them to the relevant health authorities:

• Event monitoring
• Reporting to the health authorities
• Sending safety reports, etc.

Statistical analysis of the data according to the study objectives:

• Data management and database freezing
• Statistical analysis plan (SAP)
• Statistical analysis report

Communicating the results of the study to ensure their visibility in medical and scientific circles:

• Writing articles
• Abstracts and posters
• Presentation of results at conferences and symposia

Written and oral communications