RC-AVP Design of quality clinical studies

Direct Epidemio-Statistics helps medical specialists and healthcare industry to design high quality clinical studies. We provide advice and expertise in all aspects of the design, including the analysis of the problem studied, the selection of the type of study, and the development of the statistical analysis plan.

RC-AVP / Addictions (psychiatrie)
RISK-SCO / Accident de la route
CIR / Agrément 2022, 23, 24
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What is our advisory service?

We help you at every stage of the design of your study

The points on which the consulting mission of Direct Epidemio-Statistics focuses are the question and the objectives, the choice of the type of study, the sample size, the key variables, the statistical analysis plan, the argumentation, and the support.

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Examine the issue and its objectives

We carefully review the research question and the objectives of the clinical research project, to ensure that they are clearly defined and achievable. Given our focus on epidemio-statistics, we analyze how the research project answers questions such as:

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  • Is the question clearly defined and targeted?
  • Is the research feasible?
  • Is the question important and relevant?
  • Does the question fill a knowledge gap?
  • Is the method ethical or compliant with applicable regulations and guidelines?
  • Will the research design be able to answer the question and the objectives?
  • Are the data collection and analysis methods appropriate?

Choose the appropriate type of study

We work with the clinical research team to identify the most appropriate study design for the project, taking into account the research question, available resources, and ethical considerations. In particular, we will look at whether the choice of the study:

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  • Allows you to best answer the question
  • Is feasible given the resources (time, funding, personnel)
  • Is ethically sound and follows human subject protection guidelines
  • Enables the appropriate collection of data to answer the question
  • Enables proper data analysis
  • Is realistic and feasible to implement

Calculate sample size

We work with the clinical research team to develop a sample size calculation based on statistical power and precision requirements. The size of the sample depends in particular on:

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  • Type of study
  • Desired precision
  • Estimated effect size
  • Desired statistical significance
  • The variability of the population studied
  • Available resources, such as funding or staff

Define key variables

We work with the clinical research team to identify and define the key variables that will be measured and analyzed in the study. These key variables must in particular be:

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  • Relevant to the research question addressed in the study
  • Relevant to the characteristics of the population studied
  • Relevant to the design of the study used
  • Measurable using available measurement tools
  • Collectable and scannable given resources

Statistical analysis plan

We work with the clinical research team to develop a detailed statistical analysis plan that outlines the methods that will be used to analyze the data, including any multivariate statistical methods that may be required. This statistical analysis plan :

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  • Describes how the data will be analyzed to answer the question
  • Considers study design (type of data, sample size)
  • Specifies the statistical tests used to analyze key variables
  • Specifies the level of statistical significance used
  • Specifies the assumptions of the statistical tests used
  • Specifies how missing data will be handled

Improve argument quality

We review and revise the clinical research proposal to ensure that it is clearly written, well organized and includes all necessary information and details.

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  • Clarity, efficiency, and readability of the language used
  • Logic and consistency of presentation
  • Is the order of the sections appropriate?
  • Is the presentation of the study complete?
  • Are all relevant details included?
  • Are the facts and data in the document accurate and well interpreted?
  • Are informed consent and the protection of human subjects addressed?

Expert clinical research support

We remain available to provide ongoing support and guidance to the clinical research team throughout the study, including assistance with data analysis and interpretation. We provide support for:

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  • Develop the protocol, identify the study population, or select the measures
  • Develop data collection forms, train or assist in collecting accurate and consistent data
  • Assist in developing the statistical analysis plan or interpreting statistical results
  • Provide support and guidance as needed
  • Respond to questions and address challenges as they arise
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To design studies with

the best chance of success

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Direct Epidemio-Statistics provides you with comprehensive support throughout the design process of your clinical study.

Choose us as your partner to design a high-quality clinical study that meets your research objectives and has the best chance of success.

Direct Epidemio-Statistics support should help you:

  • Better target your study and have a clear objective
  • Improve the reliability and validity of results
  • Improve your chances of having significant results
  • Improve the quality of your data and the validity of conclusions
  • Improve the quality of your arguments and therefore the impact of your research
  • Ensure your study is well planned and executed
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What are our prices? How to exchange?

Contact us today for a first appointment or a personalized quote

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Contact form

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Frequently asked questions

— 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.

Need info? You have a project ?
So get in touch to tell us about your project to be set up.