Technology unit Clinical operations
Our purpose is to give you access to well characterized, tailored high value human biological samples to accelerate your health product development projects
Access to well characterized and documented samples is a key factor to enable you to conduct health innovative product development. Challenges often met by you to access high quality human samples are :
- Quick identification of relevant clinical partners who are expert in your field, • Fast access to relevant and well characterized human samples from preparation to analysis,
- Availability of human samples whose sampling methods and storage conditions are suitable with analytical technologies that fit your quality standards,
- Organization of reliable database integrating patient clinical data, microbiological data and complex molecular data (e.g. high content readouts) generated from samples of interest,
- Human samples collection and personal data processing meet ethical principles and regulations.
Our Clinical Operations team offers you an integrated and customized approach according to the specificities of your biological question with the following assets:
- Access to a strong and global clinical network involving clinical partners from hospitals, biological resources centers, central labs, samples hubs or key opinions leaders with whom we build solid collaborations. These partnerships enable us to provide human samples solutions with high reactivity.
- Solid expertise with regulatory requirements involving human samples.
We capitalize on successful international retrospective and prospective studies and are able to provide expertise and support to your team through the regulatory procedures, from evidence research to authorities approval. Moreover, we manage human samples logistics issues of and support for international samples importation/exportation files required for authorizations.
- Implementation and coordination of prospective interventional and non-interventional clinical studies (Health product excepted) sponsored by BIOASTER to adapt to your sampling methods and storage conditions constrains.
Your project added values include:
- At your side, we are involved from the project design, to the appropriate clinical protocol writing and relevant samples acquisition.
- We identify the most suitable clinical partners for your needs and have avery close relationship with them throughout the studies,
- Our clinical studies are conducted under Good Clinical Practices (GCP) environment within ISO9001 standards,
- We ensure the clinical documentation writing: Protocol, Inform Consent Form (ICF), electronical Case Report Form (eCRF) and Standard Operational Procedures (SOP),
- We carry out the regulatory submission to the Ethical committees and competent authorities and ensure samples logistics.
Once collected and processed, samples are analyzed and characterized through our cutting-edge technologies to answer multiple biological questions, in the four main fields of applied microbiology (Vaccine, Diagnostic, Microbiota, Antimicrobials). Lien avec l’offre et les 4 “programmes”
- Implementation of retrospective studies if existing samples are identified in our network. Retrospective samples can be provided from existing cohorts or collections initially collected for diagnostic purposes can be requalified for research applications. We ensure samples selection according to the project requirements and expected quality criteria, manage the regulatory procedures and Material Transfert Agreement signature.
- Integration of clinical and microbiological data with (multi)omics data sets with high content immunology readouts to generate comprehensive integrated and actionable data reporting for our partners. eCRF solutions are implemented in our prospective studies to ensure quality data collection, controls and traceability. Personal data are shared with your team safely and confidentially using our secured solutions. Our processes comply with the standard methodologies from the French Data Protection Authority and GDPR.
- Provide biobanking capabilities for secured storage of high-value samples collected throughout our collaborative projects. We offer an efficient samples tracking solution thanks to our Laboratory Information Management System (LIMS), within high quality standard ISO9001 environment.