Clinical studies
Clinical studies
- Category 1 and 2 interventional research
- Observational studies: descriptive and/or analytical studies, medico-economic or epidemiological studies based on the SNDS.
- • Support and advice on methodological aspects
• Assessment of study feasibility
• Development of the statistical analysis plan, headcount calculation
• Selection of investigative sites based on our network
• Drafting of essential study documents : protocol, information notice and consent forms, etc.
• Support for your regulatory procedures (ANSM, CPP, CNIL)
• Creation of your electronic CRF
- • Selection visits to investigative sites
• Visits to set up the study
• Training in the protocol and good clinical practices for investigative staff
• Configuring your eCRF
- • Management and coordination of monitoring visits throughout the study (on site/off site)
• Support and management of investigative sites
• Continuous reporting & database management
• Suggest solutions to any difficulties encountered during the study (recruitment rate, compliance, queries, etc.).
• Audits of investigation sites
- • Closing site visits
• Structuring, cleaning and validation of the database
• Statistical analyzes of data collected using programming in SAS and/or R
• Medical & biostatistical writing & review of the final study report
• Presentation of the results : editing abstracts, posters and scientific publications
For more details :
1. Feasibility and study start-up
The clinical research process begins with a feasibility study, where we use our expertise to support you. Once objectives of the clinical study are clearly defined, we provide support and methodological advice for the implementation of the project.
Thanks to our network, we select the most appropriate investigative sites for your study. We work closely with you to develop the protocol, the statistical analysis plan and determine the sample size needed for the study. We also take care of the drafting of essential documents such as the protocol, the investigator brochure, the information leaflet and consent forms, etc.
In addition, we assist you in regulatory procedures with the ANSM, CPP and CNIL, thus ensuring full compliance with regulatory requirements. We are also implementing the electronic Case Report Form (eCRF) to facilitate the collection and management of data from your clinical research project.
1. Feasibility and study start-up
The clinical research process begins with a feasibility study, where we use our expertise to support you. Once objectives of the clinical study are clearly defined, we provide support and methodological advice for the implementation of the project.
Thanks to our network, we select the most appropriate investigative sites for your study. We work closely with you to develop the protocol, the statistical analysis plan and determine the sample size needed for the study. We also take care of the drafting of essential documents such as the protocol, the investigator brochure, the information leaflet and consent forms, etc.
In addition, we assist you in regulatory procedures with the ANSM, CPP and CNIL, thus ensuring full compliance with regulatory requirements. We are also implementing the electronic Case Report Form (eCRF) to facilitate the collection and management of data from your clinical research project.
2. Setting up the clinical study
Setting up a study includes several key steps, including conducting screening visits to investigator sites to assess their regulatory suitability and compliance with a research study requirements. We also conduct set-up visits to ensure each site is operational for the start of the clinical trial.
Our team can help in training the investigation staff regarding the specific protocol of the clinical reseach, as well as Good Clinical Practices (GCP). This trainings aims to ensure complete understanding and compliant execution. We also set up the eCRF to facilitate efficient data collection and processing, ensuring the reliability and quality of the information collected throughout the study.
2. Setting up the clinical study
Setting up a study includes several key steps, including conducting screening visits to investigator sites to assess their regulatory suitability and compliance with a research study requirements. We also conduct set-up visits to ensure each site is operational for the start of the clinical trial.
Our team can help in training the investigation staff regarding the specific protocol of the clinical reseach, as well as Good Clinical Practices (GCP). This trainings aims to ensure complete understanding and compliant execution. We also set up the eCRF to facilitate efficient data collection and processing, ensuring the reliability and quality of the information collected throughout the study.
3. Data monitoring and management phase
During the monitoring phase of clinical trials, our team ensures the management and coordination of monitoring visits, both on site and remotely. We support and manage the investigator sites by offering continuous reporting and managing the clinical study database.
To cope with any eventual difficulties encountered, such as low recruitment rates or questions/deviations from the protocol, we offer effective solutions to maintain the smooth running of the study. In addition, we conduct audits of the investigation sites or service providers involved in the research, to ensure compliance with the protocol and regulations, thus guaranteeing the quality and compliance of the clinical study.
3. Data monitoring and management phase
During the monitoring phase of clinical trials, our team ensures the management and coordination of monitoring visits, both on site and remotely. We support and manage the investigator sites by offering continuous reporting and managing the clinical study database.
To cope with any eventual difficulties encountered, such as low recruitment rates or questions/deviations from the protocol, we offer effective solutions to maintain the smooth running of the study. In addition, we conduct audits of the investigation sites or service providers involved in the research, to ensure compliance with the protocol and regulations, thus guaranteeing the quality and compliance of the clinical study.
4. Reporting and statistical analyzes
Site closure marks the start of the reporting and statistics phase, where we structure, clean and validate the database. Statistical analysis of the collected data is carried out using SAS and/or R programming. For more details, see our Biometrics services.
We write or review the final study report from a medical and biostatistical point of view, ensuring a clear and accurate presentation of the clinical reseach results . Finally, we prepare abstracts, posters and scientific publications to share and promote the results of the study.
4. Reporting and statistical analyzes
Closing the sites marks the start of the reporting and statistics phase where we structure, clean, and validate the database. Statistical analyzes of the data collected are carried out using programming in SAS and/or R. For more details, consult our Biometrics services.
We write or revise the final report of the study from a medical and biostatistical point of view and ensure a clear and precise presentation of the results obtained. Finally, we prepare abstracts, posters and scientific publications to share and
promote the results of the study.
By choosing Axelys Santé to manage your clinical trials, you are opting for an expert partner who places quality and compliance at the heart of its priorities. We are available to help you achieve your clinical objectives with expertise, integrity and ongoing commitment.
To find out more about how Axelys Santé can facilitate the success of your clinical research, do not hesitate to consult our services and contact our team of experts directly.
