These ten last years, the number of laboratory assays used in clinical trials has significantly increased.
Biofortis offers full service & GLP-compliant central laboratory capabilities for all clinical trials with a wide spectrum of routine analyses dedicated to the food, biotechnology and pharmaceutical industries.
Besides their scientific skills in lipid metabolism, microbiology, and molecular biology, our central laboratory staff combines expertise in project management and logistics to permanently deliver high quality flexible solutions in line with the performance and timelines needed for a successful completion of your project.
Biofortis has also developed a strong know-how in the management of complex research projects, involving either multiple investigative sites or specialized testing .
Clinical trials have become complex, especially due to their multicenter nature. Consequently, samples logistics is now one major issue to address and central lab logistics is crucial.
Our Biofortis central lab staff, which shows a strong knowledge in clinical trial issues, perfectly knows the importance of a solid and high performing Logistics and that samples have to be shipped according to timelines issues and sample integrity. For that, our team has reviewed appropriate courier and continuously manages courier performance, cost and transit times for a cost effective and appropriated service.
The validated sampling collection method and dedicated kits preparation.
- Customized kits (e.g. pediatrics kits)
- Preclinical and clinical studies
- Shipment of kits supplies on demand
- Samples centralization
- Blood, stools, urines
- Dedicated analytical platform
- Routine and specialized biology
- NGS platform for microbiota analyses
- Strong expertise in sample prep
- R&D team, supporting methods validation and innovation
Central Laboratory Parameters.pdf
- ISO 9001 certified
- ICH, GCPs and GCLPs compliance
- CAP certified
- Étude mono et multi-sites
- Gestion logistique des kits et échantillons
- Équipe projet dédiée
- Expertise clinique
- Résultats transmissibles en plate-forme web
- Études prospectives : collecte d’échantillons frais à façon (CEBH)
- Centre d’Investigation Clinique interne Biofortis (infirmier, médecin…)
- Système informatique de gestion des biocollections
- Sample reconciliation
- Dedicated and secure interface for biological data
- Audit trail
- In-house LIMS for lab and web portal for lab reports
- Data base transfer according to sponsor requirements