Biometrics & Data Science
With a wide range of skills, our internal experts in the field of data and scientific interpretation will support your projects in order to extract maximum value and insights from your biological data and maximize your return on investment.
our global offer
Data Management
Provide reliable data
Collect, check and share are the main activities of our Data Management department, with a unique objective: to provide the most accurate database for the final statistical analysis. Our internal dedicated Data Managers conduct these activities under high-quality and standardized process (SOPs) and by using in-house dedicated tools (eCRF, …) and SAS® software.
- CRF/eCRF Design
- Database validation
- Access account management
- Data Entry plan
- Data Acquisition: Data entry and Data import
- Data Validation, based on a Data Validation Plan (DVP)
- Data Coding: MEDRA, WHODrug
- Blind review & Database finalization: Unblinding database lock
- Secured data transfer to the Sponsor
our "plus"
✔ Multiple Data acquisition interfaces (clinical or not)
✔ Health Data Hosting infrastructure: data security and privacy
✔ Custom internal database developments
✔ Flexible Electronic Data Capture systems (eCRF, ePRO (Patient Reported Outcomes, …)
Biostatistics
DESIGN, DESCRIBE & MODELIZE
Biostatistics department gathers highly experienced statistical programmers and biostatisticians trained in advanced statistical methodologies and standard good clinical practices involved in randomized clinical trials and observational studies. Statistical programming is carried out using SAS® software for most of the clinical projects and can be adapted to other statistical languages such as R according to your needs.
The Biostatistics department is involved, in randomized clinical trials and observational studies.
In the earliest phases of the project
- Insights into experimental design and study protocol writing
- Sample size calculation
- Randomisation schedule
- Statistical Analysis Plan (SAP)
STATISTICAL ANALYSIS AND REPORTING OF RESULTS
- Preparation of the data review
- Production of TFLs (Tables, Figures and Listings)
- Graphical visualizations and descriptive statistics
- Comparative analyses and statistical modeling
- Meta-analyses
- Support for publication writing
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OUR PLUS
– Highly qualified team (Master’s or PhD in statistics) with extensive experience in a broad range of clinical and health science settings.
– Methodology: literature review, continuous training and internal R&D to provide up-to-date methodologies
– Knowledge of methodological international standards in planning, analysis and reporting of clinical trials (ICH, EFSA, CONSORT, STROBE AND PRISMA)
– Support for your internal R&D projects
Bioinformatics
Develop & optimize
In the omics field, bioinformatics provides for the development of tailored pipelines combining well referenced algorithms and in-house custom scripts.
Our expertise covers both metabarcoding (16S, ITS) and metagenomics (Shotgun) but also Whole Genome Sequencing (WGS), as well as ad hoc work. We have full control of our IT infrastructure to ensure fast and reproducible analyses.
Our “Plus”
– Highly experienced with NGS data related to microbiome analysis
– Access to internal and external high performance computational resources
– Customized services: adaptation of current practices and workflows to customer feedback and needs
– Expert network in bioinformatics
Other main services
– Workflow automation / Pipeline implementation
– Support for article writing
Internal applications:
Data Science
ARTIFICIAL INTELLIGENCE/Machine learning
Our Data Science team proposes to have another angle of view on the data, using exploratory approaches leveraged by machine learning. Using data integration of your entire datasets, we would like to value the potential benefits observed in your clinical research and biological data, by characterizing the best responders, identifying new marketing insights from discovered hidden patterns, and possibly, learn how to optimize a future clinical trial design.
What do we do ?
✔ Valorization of unsuccessful trials
✔ Multi-source data integration
✔ Advanced analysis of microbiome and multi-omics data
✔ Responder characterization
✔ Biomarker discovery and microbiome signatures
Our approach
✔ Starter Exploration Pack: minimal set of exploratory analysis to bring first insights on trends
✔ Sequential step by step approach with Go/ No Go checkpoints
✔ A flexible and collaborative approach
✔ Feasibility checking and financial risk reduction of data exploration
added value of data science
✔ Deeper scientific understanding of underlying phenomena
✔ New marketing insights from discovered hidden patterns
✔ Optimization of clinical trial design
✔ Improved recruitment from refined inclusion / exclusion criteria
our "plus"
✔ Flexible, collaborative framework with customers
✔ Exclusive dedication to project – TAT
✔ Analytic methods adapted to data features and sample size
Medical Writing
Embedded in a clinical trial project or as a stand-alone project, our team of scientists and medical writers support sponsors to create value from their ideas and data.
Bring your ideas and data to light with the help of our scientists & medical writers.
PROOF OF CONCEPT
✔ Bibliographic research on your topics of interest (product category, health condition or disease, …)
✔ Advise on study design: refinement of objectives and targeted populations, definition of study endpoints and identification of biases
CONDUCT OF CLINICAL TRIALS
Writing of all clinical study materials including:
✔ Study synopsis and protocol,
✔ Information leaflet,
✔ Case report form,
✔ Clinical study report (ICH E3 compliant) *
valorisation
✔ Help in scientific result interpretation
✔ Participation in all types of support of valorization and dissemination of your results: marketing presentations, scientific posters, oral communications, peer-reviewed articles…
Our “Plus”
- Multidisciplinary team
- Compliance with standards and regulations
Our approach
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Customized solutions
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Open-minded interactions
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Feasibility check and financial risk reduction of data exploration