Biostatistics

Q: What is a Statistical Analysis Plan (SAP), and what is it used for?

The SAP is the document that, prior to database lock, details all the statistical methods planned for analyzing a clinical trial: endpoints, estimands, analysis methods, and handling of missing data.

Q: What is the difference between the SDTM and ADaM standards in clinical research?

The SDTM organizes the raw data collected during the study into a standardized format, while ADaM organizes this data to directly generate the statistical analyses and deliverables (TLFs) required by regulatory authorities.

Q: What is the difference between an interventional study and an observational study?

An interventional study (Phase I–IV clinical trial) involves an intervention defined by the protocol, whereas an observational study analyzes existing or newly collected data without altering patient care, for descriptive or association purposes.

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What is biostatistics, and why is it essential in clinical research?

Our biostatisticians support your clinical research and real-world data generation projects, from study design through analysis and interpretation of results. Whether it’s interventional clinical trials, observational studies, primary or secondary data, or medical-administrative databases, we tailor our statistical strategy to the nature of your data and your scientific and regulatory objectives.

Drawing on our expertise in SAS®, R, and Python, we produce robust analyses and deliverables tailored to your needs, ranging from sponsor-specific formats to the CDISC standards required for certain international regulatory submissions.

A robust scientific basis

We get involved right from the study’s conception phase to define a statistical strategy that is consistent with the scientific objectives, the study design, and the available data.

Study Design and Statistical Methodology: Defining the study design, outcome measures, and estimands; calculating sample size and statistical power; selecting analytical methods; and drafting the Statistical Analysis Plan (SAP)

Anticipating statistical challenges: Identifying potential biases, managing missing data, defining sensitivity analyses, and selecting methods appropriate for the study context.

Statistical guidance throughout the project: Methodological support from the drafting of the protocol through the interpretation of results and scientific or regulatory discussions.

Expertise tailored to each type of study

Statistical methodology cannot be the same for every study. Our teams tailor the analytical methods to the study design, the source of the data, and the research question—whether the goal is to demonstrate efficacy, assess an association, or generate real-world data—in a manner consistent with the scientific objectives, the study design, and the available data.

Interventional Clinical Trials: Support for Phase I through IV trials, from sample size calculation through final, interim, and sensitivity analyses, taking into account applicable regulatory requirements.

Observational studies & primary data collection: Analyses of prospective or retrospective studies based on data specifically collected to address the research question: cohort studies, registries, care pathway studies, or real-world studies.

Secondary Data & Real-World Data: Analysis of existing data from medical-administrative databases, medical records, registries, or other health data sources, using methodologies tailored to address biases, confounding factors, and the characteristics of observational data.

Studies on the SNDS: Definition of study populations and analysis criteria; descriptive and comparative analyses; longitudinal and survival analyses; adjustment for confounding factors; and statistical analysis of large-scale data.

Data tailored to your needs and CDISC standards

We produce your datasets and statistical deliverables in accordance with the standards defined with your organization or with the international standards required for your regulatory projects. Our teams can therefore work with data in its sponsor-provided format as well as standardize it according to CDISC guidelines.

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Formats Tailored to the Sponsor’s Needs: Production of analytical datasets and statistical deliverables in formats agreed upon with the client, enabling direct use of the data and results.

CDISC Standards – SDTM & ADaM: Structuring and programming data in accordance with the SDTM standard for tabulation data and the ADaM standard for analysis datasets, ensuring standardization, traceability, and reproducibility.

Conversion of existing data: Mapping and conversion of historical databases or sponsor formats to CDISC standards when required for a submission or to harmonize a development program.

Actionable results ready to be put to use

Beyond statistical analysis, we transform the results into clear, traceable deliverables that can be directly utilized by clinical, medical, and regulatory teams.

Statistical Programming & TLFs: Production and quality control of tables, listings, and figures; automation of programs in SAS® and R; and generation of reproducible deliverables.

Reporting & Visualization: Statistical reports, visualizations, and dashboards designed to facilitate the interpretation, monitoring, and communication of results.

Support for scientific and regulatory deliverables: Statistical contributions to Clinical Study Reports (CSRs), publications, scientific presentations, integrated analyses, or other documents necessary for the interpretation and submission of results.

Statistical Management of Clinical Trials

In addition to study design and analysis, our biostatisticians support sponsors through the key statistical steps necessary to ensure the safety and proper conduct of clinical trials, in accordance with the protocol and regulatory requirements.

Biostatistics Rigorous analysis and interpretation

Randomization: Design of randomization schemes, definition of stratification and blocking methods, generation and monitoring of randomization lists, and management of blinding-related constraints.

Interim Analyses: Planning and conducting the interim analyses specified in the protocol, including the implementation of appropriate statistical methods and the production of secure and traceable deliverables.

DSMB / Data Safety Monitoring Board: Statistical support for independent data safety monitoring boards: preparation of statistical analyses and reports, production of the outputs required for data review, and participation in the DSMB process throughout the study.

Expertise and quality teams

Our team members combine scientific expertise, methodological rigor, and practical experience. Each of them is committed to ensuring the reliability, compliance, and success of your projects through their professionalism. Driven by a strong culture of quality and teamwork, our experts are fully dedicated to shaping new approaches to medical care.

Statistical expertise at the service of your studies
clinical studies to inform your decisions

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Compliance & Security

Our services comply with the most stringent regulatory frameworks governing health data.

Your clinical data is hosted exclusively by providers certified as Health Data Hosts (HDS), in accordance with the requirements of the ANS and Article L.1111-8 of the Public Health Code.

Your personal data is processed in accordance with the GDPR and the CNIL's best practices.

Frequently Asked Questions

What is a Statistical Analysis Plan (SAP), and what is it used for?

The SAP is the document that details, prior to the database lock, all of the statistical methods planned for analyzing a clinical trial: endpoints, estimands, analysis methods, and handling of missing data.

What is the difference between the SDTM and ADaM standards in clinical research?

The SDTM structures the raw data collected during the study according to a standardized format, while ADaM organizes this data to directly generate the statistical analyses and deliverables (TLFs) required by regulatory authorities.

What is the SNDS, and how is it used in biostatistics?

The SNDS (National Health Data System) is a French medical-administrative database that compiles reimbursement and hospitalization data. It enables large-scale descriptive, comparative, and survival analyses to be conducted on real-world populations.

What is a DSMB, and what is its role in a clinical trial?

A DSMB (Data Safety Monitoring Board) is an independent committee responsible for monitoring participant safety and data validity during a clinical trial, based on regular statistical analyses.

What statistical tools does MultiHealth Group use for its analyses?

Our biostatisticians work with SAS®, R, and Python, which allows us to support both sponsor-specific formats and the international CDISC standards required for certain regulatory submissions.

What is the difference between an interventional study and an observational study?

An interventional study (Phase I through IV clinical trial) involves an intervention defined by the protocol, whereas an observational study analyzes existing data or data collected without altering patient care, for descriptive or association purposes.

Our teams are at your service

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