A la carte services
Axelys Santé offers you its à la carte services.
A la carte services
Axelys Santé offers you its à la carte services.
Axelys Santé can assist you in setting up all types of clinical research:
- Clinical drug trials, clinical investigations of medical devices, performance studies of in vitro diagnostic medical devices ;
- Other category 1 and 2 interventional research
- Observational studies: descriptive and/or analytical studies, medico-economic or economic or epidemiological studies based on the SNDS.
We act as your reliable partner so that you can benefit from our complete expertise and personalized support in setting up and developing your clinical studies. Whether you need us to manage an entire project, or to carry out specific tasks such as biometrics or clinical trial monitoring.
A la carte services : Biometrics
Study set up
Methodological recommendations : design, size sample calculation and statistical analysis plan
Our team of scientific project managers and biostatisticians will support you in setting up your clinical research project by providing you with appropriate methodological recommendations. We’ll help you define your study objectives and endpoints, and calculate the required number of participants based on a literature review. In addition, we set up a rigorous statistical analysis plan, specifically adapted to your study, to guarantee accurate and reliable results.
Drafting documents and forms
We also handle the drafting of all documents required for the study. This includes the medical drafting of the protocol, as well as the information notes and consent forms for research subjects. We can also, for example, take part in the preparation, implementation and deployment of electronic forms and intended for study patients.
In addition, our services extend to surveys of healthcare professionals: data collection on the use of healthcare products, evaluation of professional practices, or any other relevant survey.
Data collection and data management
We offer a complete service for collecting, structuring and validating the data required for your study:
1. Data collection: We work with you to define the relevant variables and data to be collected for your study. Depending on your needs and the nature of the study, we can create and deploy appropriate Case Report Forms (CRFs), either an electronic form (eCRF) or paper. These CRFs are designed to capture the necessary information in a clear and systematic way.
2. Structuring and clearing the database : Once the data has been collected, we structure it so that it is ready for analysis. This involves organizing the data in a database according to a predefined layout, and clearing it to eliminate any errors or inconsistencies.
3. Data validation: We ensure that the data collected is reliable and accurate by carrying out rigorous validation. This may include consistency checks, feasibility analyses and comparisons with external sources. To formalize this process, we draw up a Data Validation Plan (DVP) and/or a Data Management Plan (DMP) at your request.
Statistical analysis
Our support extends to all aspects of statistical analysis, covering a wide range of technical areas such as correlation analysis, generalized linear models, logistic regressions, survival models, competitive hazard models, and much more. We mainly use two programming languages widely recognized for their power and flexibility: SAS and R.
These tools enable us to efficiently manipulate data, implement advanced analytical methods and produce reliable, reproducible results.
Whether for observational studies, clinical trials or other types of analysis, our rigorous approach ensures that your statistical analysis needs are fully addressed.
Presentation of the results
After conducting these in-depth statistical analyses, we provide an end-to-end report on the results. Axelys Santé will work with you to ensure that your results are presented in a clear and precise layout, both orally and in writing. Whether for public lectures or written documents, our expertise ensures that your analytical data are communicated in an effective and impactful way.
Contact us to discuss your specific needs in terms of biometrics or surveys for healthcare professionals.
A la carte services : Monitoring & Data Management
Explore our extensive range of Monitoring & Data Management services designed to meet your specific clinical trial management needs. With our proactive approach and commitment to excellence, you can be confident in our ability to conduct your clinical study successfully, from design to closure.
Monitoring & Data Management: Ensuring Data Quality
Ensuring data quality is fundamental to guaranteeing reliable results that comply with regulatory standards. We have validation processes designed to ensure that the data we collect is accurate and complete. Our expert team of pharmacists, clinical project managers and Clinical Research Associates are committed to the rigorous management of your study’s clinical data.
Management and Coordination of visits: continuous monitoring
Effective management of investigator sites’ visits is essential for the successful conduct of clinical trials. Our team coordinates monitoring visits throughout the study, whether on site or remotely, guaranteeing ongoing follow-up. Moreower, we are convinced that transparency and communication with investigator sites are essential to ensure that the study runs effectively and that any difficulties encountered are quickly resolved. Our experts also provide ongoing reporting to keep you updated on the status of your study and ensure efficient monitoring of your clinical trials.
Support and Management of Investigation Sites: Operational Excellence & Guarantee of Conformity
We offer full support and guidance of investigation sites (protocol training, Good Clinical Practices, etc.). As an essential part of our commitment to quality and compliance, we also conduct in-depth audits of investigation sites.
Solutions for Performance Optimization
Our experience enables us to offer customized recommendations to optimize your study’s performance. In addition to database management, we are committed to providing you with innovative solutions to any difficulties that may arise during the course of your clinical trial, such as recruitment issues, compliance, queries, and much more.
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.
A la carte services : Quality Management System
To meet the specific Quality Management System (QMS) needs of your company (pharmaceutical laboratory, start-up, biotech, medtech, etc.), our quality experts offer a range of services. These include analyzing your processes, identifying risks, reviewing your Quality Policy, planning your audits and, more generally, providing customized support to meet the requirements of the international ISO 9001 standard. We support you from the initial design to the implementation and maintenance of your QMS to ensure the quality and reliability of your internal processes.
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.
