IC@dom, a team of clinical research experts at every stage of your project
Are you looking for comprehensive support for the development of new medical devices or new treatments, from the design of the clinical study through to the evaluation of the results? Or are you simply looking for expert support to help you complete a specific stage of your clinical trial?
We’re here to help.
IC@dom’s multidisciplinary team can provide you with personalised support: we can take complete charge of your clinical study or provide specific services according to your needs.
A question, a quote? Please do not hesitate to contact us.
A full range of expertise
Our teams work closely with the sponsor and the investigator to co-design the project and to precisely define its scope. This upstream phase is crucial to the quality of the whole study:
- Methodological support, sample size calculation
- Selection of centres
- Drafting the clinical investigation plan and other documents relating to the study (information and consent forms, support documents, etc.)
- Risk analysis (impact analysis, RGPD)
- Training in good clinical practice (GCP), etc.
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
Designing the project
Design and preparation of the CRF and e-CRF (Case Report Form)
On-site and remote monitoring
Clinical investigation within the person’s home
Promoting the results