RC-AVP Design of quality clinical studies

— What is the experience and expertise of Direct Epidemio-Statistics in the design of clinical studies?

The team members have a solid academic background, with advanced degrees in machine learning and postdoctoral experience in epidemio-statistics. Team members have published in leading journals. And the company is CIR approved by the Ministry of National Education and Research in France (2022-23-24). This combination of education, training and professional experience gives the team a high level of expertise in the design of clinical studies and in epidemio-statistics to improve the design of these studies.

— How does advice from Direct Epidemio-Statistics improve the design of clinical studies?

Our guidance aims to improve the design of clinical studies through a series of elements, including study target and clarity of purpose, appropriate choice of study type, calculation of optimal study size sample, identification and definition of key variables, improvement of the quality of arguments and support throughout the design process. By focusing on these key points, we help our clients design more reliable, valid and impactful clinical studies, and contribute to the proper planning and execution of studies.

— What specific services does the consulting service offer to improve the design of clinical studies?

Direct Epidemio-Statistics provides a range of services to improve the quality and impact of clinical research projects submitted to calls for projects. These services may include assistance in defining the research question, selecting the appropriate study design and sample size, identifying and defining key variables, reviewing and providing feedback on the project, developing a strong research argument, provide training and support in data analysis and visualization, and provide guidance on effective communication of the project and results. By leveraging our expertise in epidemio-statistics and clinical research design, these consulting services can help you increase the chances of your projects being accepted and funded.

— How do you meet specific needs and goals?

Direct Epidemio-Statistics adapts to each clinical research project by working closely with the client to understand their specific needs and objectives, and by customizing the services offered to meet their needs. This personalization can manifest itself in special training or support, a personalized plan improving the design of the project, advice on key points such as the definition of the research question, the appropriate choice of the type of study and the size of the sample, the identification and definition of key variables, or the development of a solid research argument. By adapting to your specific needs, Direct Epidemio-Statistics helps you achieve the desired results and increase your chances of success.

— What is the cost of consulting services?

Pricing for Direct Epidemio-Statistics services varies depending on several factors, including whether it is a one-time consultation or an ongoing contract, the budget of the clinical research project, and the nature of the client. For example, a single consultation is usually more expensive than a consultation that is part of a longer collaboration with multiple consultations because a longer collaboration involves time and resources that can be spread over a longer period, while a one-time consultation requires a more intensive and focused effort, resulting in a higher one-time cost. Also, the price is affected by the involvement or not of the consultants in the dissemination of the results in scientific journals and the visibility that this brings.

— How do we stay up to date with the latest developments?

Direct Epidemio-Statistics maintains its up-to-date knowledge in the field of clinical research by working with experts and using resources such as academic journals and industry publications.

— How does Direct Epidemio-Statistics communicate and work with its clients to ensure their needs are met and advice is effective and efficient?

Direct Epidemio-Statistics ensures your needs are met by discussing progress with you, using online management and collaboration tools and techniques, collecting your feedback, and setting clear goals for the consultation. We adapt and revise the plans if necessary.

— How does billing work in a public hospital?

Direct Epidemio-Statistics understands that billing processes can be complex, especially for public hospitals. In France, your public hospital most certainly uses CHORUS, the national portal of the State which simplifies and accelerates the process of payment of service providers by public administrations including hospitals. Billing requires the principal investigator (PI) to be authorized to sign a quote (if applicable, add someone with this authority such as a department head). Then, all you have to do is tell us the target service to route the digital invoice to. In terms of VAT, the amount is generally not relevant for the decision of expenditure and budget because hospitals are also VAT collectors.

— What are the deliverables?

A summary document (PDF in English or/and French) summarizing the epidemio-statistical and methodological contributions will be submitted. Depending on the scope of the mission, certain contributions can be made directly in the documents of the file (word, spreadsheet). Each complete mission includes an on-site restitution. Depending on the distance with Rennes, a kilometer participation can be added.

— How long does it take?

For a normal project it takes 14-28 calendar days. This deadline depends on the scope of the mission (complete, partial), our familiarity with the subject treated, our load plan, and your needs. In general, any mission starts when the order is signed and ends no later than the date of submission of the call for projects.

— What are the prerequisites for the mission?

The mission requires to estimate the order of magnitude of the project budget in EUR-TTC, to define the duration of the project (12, 18, 24, 36 months or more), to be a statistical and method contributor to the project, to know any element influencing the collection of data in terms of costs or risks, and to know any element influencing the epidemio-statistical analysis in terms of working hypotheses, sampling, power, or correlation, etc.