Clinical trials services
From study design and protocol writing to reports and publications, Biofortis manages all steps of clinical trial management to assess effectiveness, safety and tolerance of your product. Supported by our two own private Clinical Investigation Units in Nantes and Paris (France) and an international network of key partners, Biofortis as SMO, has access to all required tools to accompany you in your trials.
from standard services
to custom approaches
GLOBAL NETWORK OF PARTNERS:
EUROPE / usa / ASIA
For foodtech and biotech industries : ingredients, food supplements, functional foods, infant formula, food for specific medical purposes, medical devices, drug candidates, etc.
OUR PROCESS IN CLINICAL TRIALS
Study design & feasibility
Biofortis assists customers in the development of study designs and feasibility studies in accordance with ICH GCP Standards and all regulations in force.
Once the customer needs are well understood, Biofortis provides provides sample size calculation using published data or results from existing studies. For the feasibility study, Biofortis gathers relevant information for the execution of the study: logistics, recruitment sites in specified geographic areas, the desired criteria for sites, investigator experience and qualifications (e.g. sites led by key opinion leaders).
✔ Feasibility study
✔ Protocol writing
✔ Submission to the competent authorities
✔ SITE MANAGEMENT
✔ METHODOLOGICAL SUPPORT
Biofortis specialists in regulatory affairs provide a wide range of services to companies in food supplements, ingredients, medical devices, pharmaceutics and biotechnology. We have extensive experience in regulatory document preparation as well as client-focused project management, with a strong track record of successful outcomes (National Competent Authority, Ethical committee, GDPR, CNIL, EFSA). We provide timely strategic advice to facilitate the development and maintenance of our clients product life cycle.
Our Clinical Investigation Unit in Nantes, France
Biofortis has two Clinical Investigation Units located in Paris and Nantes which are fully equipped (rooms for clinical exams, product storage, …) and with a Dual-energy X-ray Absorptiometry (DXA) imaging platform able to determine body composition and perform osteodensitometry measurements, unique in Europe.
clinical Investigation units: Nantes / Paris
volunteers in our database
Management of volunteer indemnities
Investigational visits including clinical assessments in accordance with the protocol, safety monitoring in compliance with Good Clinical Practices (GCPs)
In situ support by our clinical study technicians
Collection of biological samples
Management of product/treatment units (storage, dispensation, destruction)
Clinical trial coordination
Biofortis dedicates a specific project team to all steps of your project during the entire study. This specific project team takes care of:
✓ Regulatory follow-up (mandatory declarations to the authorities)
✓ Sample logistics
✓ Clinical monitoring: Initiation visit, audit of volunteer records (Source Data Verification), monitoring reports, closing visit
✓ Site Management
✓ Blind review, Blind review report
✓ Validation of statistical outputs
✓ Writing of the final study report in ICH format
investigations sites supported worldwide
Full service & GLP-compliant central lab capabilities for all clinical trials. At our ISO 9001:2015 and GCLP-compliant cutting-edge laboratory facilities, our Central Lab routinely supports 100+ investigation sites worldwide for sampling kits, sample logistics, study documentation, centralized analyses with hundreds of biological parameters in our catalog, and biobanking services.
DATA MANAGEMENT & BIOSTATISTICS
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.
SCIENTIFIC & 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) *
✔ 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…
- Multidisciplinary team
- Compliance with standards and regulations
Feasibility check and financial risk reduction of data exploration
ASK OUR EXPERTS
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