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.

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our global offer

data management biofortis
biostatistics biofortis
medical writing biofortis
bioinformatics biofortis
data science biofortis

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 finalisation: 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 department gathers highly experienced statistical programmers and biostatisticians trained in advanced statistical methodologies and standard good clinical practices involved in randomised 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.

In the earliest phases of the project
  • Insights into experimental design and study protocol writing
  • Sample size calculation
  • Randomisation schedule
  • Statistical Analysis Plan (SAP)
  • Preparation of the data review
  • Production of TFLs (Tables, Figures and Listings)
  • Graphical visualisations and descriptive statistics 
  • Comparative analyses and statistical modeling 
  • Meta-analyses 
  • Support for publication writing 


    – A 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 international methodological standards in planning, analysis and reporting of clinical trials (ICH, EFSA, CONSORT, STROBE and PRISMA) 

    – Support for your internal R&D projects



    Develop & optimise

    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 analysis. 

    Our “Plus”

    A highly experienced with NGS data related to microbiome analysis

    – Access to internal and external high performance computational resources

    Customised 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: 

    shotgun wgs metabarcoding biofortis

    Medical Writing

    medical writing biofortis

    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.  


    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


    Writing of all clinical study materials including:

    ✔ Study synopsis and protocol,

    ✔ Information leaflet,

    ✔ Case report form,

    ✔ Clinical study report (ICH E3 compliant) * 


    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

    • Customized solutions

    • Open-minded interactions

    • Feasibility check and financial risk reduction of data exploration

    data science services