Our services in Biofortis

Thanks to our Clinical Investigation Unit and Central Laboratory, Biofortis offers global and continuous solutions to help you substantiate your products and maximize their market impact.

We offer a full range of services

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Clinical Expertise

Full clinical trial management on mono and multicentric studies to assess effectiveness, safety and tolerance of your product.

For food, biotech, pharma and cosmetics industries : ingredients, food supplements, functional foods, food for specific medical purposes, medical devices, drug candidates, etc. 

How ?

A database of more than 15,000 volunteers is managed by our experts in our dedicated Call Centre.

Two Clinical Investigation Units located in Paris and Nantes fully equipped (storage room for study products, rooms for clinical exams, etc.) with a unique access in Europe to a Dual-energy X-ray Absorptiometry (DXA) imagining platform able to determine body composition and perform osteodensitometry mesurements.  

Metabolic and physiological exploration through an internal Central Lab with over 250 parameters in routine use & next generation sequencing platform.

Who ?

A qualified clinical team dedicated to conducting and managing clinical trials from ideation to the clinical study report / publication: clinical and laboratory project managers, methodologists, clinical research associates, physicians, and data managers. 

A Clinical Investigation Unit with our dedicated senior investigators, technicians and study nurses. 

An important network of general practitioners and specialists (pediatricians, gastroenterologists, gynecologists, etc.) and several collaborations with private or public institutions in France, Europe, China and the USA.

Why ?

A strong expertise with over 500 clinical projects conducted in the last 15 years.

Diversity of nutrition expertise: gastroenterology, metabolism, infant nutrition, weight management, sleep issues, women health, immunity, etc.

Maximize and improve your market impact by presenting scientific assessments of your product.

Microbiome

Human and animal studies on multiple microbiomes: gut, oral, skin, urine, vaginal, …

More than 100 pre-clinical and clinical protocols integrating a microbiome component designed and conducted by Biofortis.

How ?

In-house NGS platform to:

  • assess microbiome diversity and composition with metabarcoding (Illumina MiSeq)
  • add functionality with shotgun metagenomics (Illumina NextSeq)
  • get down to strain level characterization with Whole Genome Sequencing of bacterial isolates (SNP and wgMSLT calling on Illumina ISeq & MiSeq).

More than 250 routine and specific assays available (IL, IgAs, TNF, CBC, SCFA, lipid profile, hepatic function, inflammation…) to complete your exploration of the microbiome-host interaction.

Microbiome studies supported by a full service Central Lab (site management, sampling kit logistics, study documentation, biobanking).

Who ?

A dedicated team including both technicians, biologists, molecular biologists, bioinformaticians, data scientists and statisticians.

They total over 10 years of experience in microbiome study and are connected to a scientific network including microbiome experts, clinicians & scientists.

Why ?

Because your product:

  • might act on/through microbiome
  • might be impacted by microbiome
  • might be microbiome friendly

Biofortis, as the only integrated microbiome services provider, can help you with valuable customized outputs: from raw data to study report, slideshow, scientific poster/paper.

Central Lab

A full service Central Lab which routinely supports around 100 investigation sites worldwide (site management, sampling kit logistics, study documentation, analyses, biobanking) in a high quality environnement with full traceability process under ISO9001 certification and GCLP compliance.

How ?

Sampling kit logistics entirely supported in-house from delivery to centralisation for biobanking or analysis.

An analytical catalog of more than 300 routine and specific assays available (IL, IgAs, TNF, CBC, SCFA, lipid profile, hepatic function, inflammation…) and a strong expertise in microbiome exploration.

Who ?

A dedicated team of Lab technicians and Lab Project Managers strongly connected to all other Biofortis teams (QM, IT, scientific support, R&D, data, bioinformatics & statistics).

Why ?

Customized services:

  • ad hoc sampling kit for all population types (adult, infant, animal)
  • Study documentation (laboratory manual, technical instructions, pocket cards…)
  • Centralisation of all analytical requests in-house or through a strong network of fully validated analytical partners.

Historical expertise with an implication in more than 200 pre-clinical and clinical studies worldwide.

Data Analytics

Dedicated team of experts, transversal support for our activities, able to intervene at each step of the data life cycle, from your working hypotheses, to the generation, the centralisation and leveraging of value of your data.

How ?

Data Management: data collection, checking and cleaning to ensure high quality and robust inputs for deeper investigations. CRF and other internationally recognised digital tools.

Data visualisation: one of the first steps of data mining by exploring data through custom static or interactive intuitive graphical representations.

Statistical Analysis: from the earliest phases of your project, including insights into your experimental design, sample size calculation, randomisation schedule, Statistical Analysis Plan (SAP), SAS/R programming of advanced statistical methodologies and meta-analyses.

Artificial intelligence: aggregate and analyse multi-source data using machine learning approaches.

Bioinformatics: in the omics field, development of tailored bioinformatic pipelines combining well referenced algorithms and in-house custom scripts.

Who ?

Highly trained and experienced collaborators with complementary skills: statistical programmers, biostatisticians, bioinformaticians and data scientists.

Why ?

Our Data Analytics task force to support you in the understanding and valorisation of your data (marketing insights, scientific publications, data-driven decisions), in the framework of preclinical studies, clinical trials (observational, interventional or epidemiological) or in the omics field.