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, documented samples greatly enables innovative health-product development. The challenges that are often met when attempting to access high-quality human samples are:
- The rapid identification of relevant clinical partners who are experts in your field,
- The rapid access to relevant, well-characterized human samples from preparation to analysis,
- The availability of human samples that have been collected and stored in a way that is compatible with the desired analytical technologies and quality standards,
- The availability of a reliable database that integrates patient clinical data, microbiological data, and complex molecular data associated with the samples,
- The collection of the samples and associated personal data that are compliant with the appropriate ethical principles and regulations.
To help you accelerate your product development, our Clinical Operations team is at your side to overcome these challenges and provide you access to high-value and complex human samples that conform to quality standards (ISO 9001). We help your team obtain complex samples, such as samples from patients with rare or neglected diseases, strains isolated from specific matrices, highly pathogenic samples, samples from healthy volunteers, or samples for which there are regulatory or logistical challenges.
Our Clinical Operations team offers you an integrated and customized approach, according to the specifics of your biological question, making use of the following:
- Our access to a strong, global clinical network, including clinical partners in hospitals, biological resource centers, central labs, sample hubs, and key opinions leaders, with whom we build solid collaborations. These partnerships enable us to provide highly specific human sample solutions.
- Our expertise regarding the regulatory requirements for the use of human samples.
By capitalizing on our record of successful international retrospective and prospective studies, we are able to provide expertise and support for your team in negotiating regulatory procedures, from the search for evidence to approval by the appropriate authorities. Moreover, we manage the logistics associated with the use of human samples, including by providing support for the documents required for importation or exportation.
- Support for the implementation and coordination of prospective interventional and non-interventional clinical studies (health products excepted) sponsored by BIOASTER, tailored to the constraints on your sampling methods and storage conditions.
We add value to your project as follows:- At your side, we are involved in the project design, the writing of an appropriate clinical protocol, and the acquisition of relevant samples.
- We identify the most suitable clinical partners for your needs and maintain a close relationship with them throughout the study.
- We ensure the clinical documentation writing: Protocol, Inform Consent Form (ICF), electronical Case Report Form (eCRF) and Standard Operational Procedures (SOP).
- We submit the documents to Ethics committees and competent authorities, and manage the logistics associated with the samples.
- Our clinical studies are conducted in a Good Clinical Practices (GCP) environment and in accordance with ISO9001 standards.
- The initiation of a retrospective study if pre-existing samples are identified within our network. Samples can be provided from existing cohorts or collections that were initially obtained for diagnostic purposes and can be repurposed for research applications. We ensure that the samples are selected according to the project requirements and the quality criteria, manage the regulatory procedures and complete Material Transfer Agreements.
- The integration of clinical and microbiological data with (multi)omics datasets and high-content immunology readouts, to facilitate the generation of comprehensive, integrated, and actionable data for our partners. eCRF solutions are implemented in our prospective studies to ensure the collection of quality data, the use of appropriate controls, and traceability. Personal data are shared with your team safely and confidentially using our secure solutions. Our processes are compliant with the standard methodologies of the French Data Protection Authority and GDPR.
- The provision of biobanking solutions for the secure storage of high-value samples collected through our collaborative projects. We offer efficient sample-tracking solutions through our Laboratory Information Management System (LIMS), within a high-quality ISO9001 standard environment.
Once collected and processed, samples are analyzed and characterized using our cutting-edge technologies, in order to answer questions, in the four principal fields of applied microbiology : Vaccines, Diagnostics, Microbiota, and Antimicrobials.
To help you accelerate your product development, our Clinical Operations team is at your side to overcome these challenges and provide you access to high-value and complex human samples that conform to quality standards (ISO 9001). We help your team obtain complex samples, such as samples from patients with rare or neglected diseases, strains isolated from specific matrices, highly pathogenic samples, samples from healthy volunteers, or samples for which there are regulatory or logistical challenges.
- The initiation of a retrospective study if pre-existing samples are identified within our network. Samples can be provided from existing cohorts or collections that were initially obtained for diagnostic purposes and can be repurposed for research applications. We ensure that the samples are selected according to the project requirements and the quality criteria, manage the regulatory procedures and complete Material Transfer Agreements.
- The integration of clinical and microbiological data with (multi)omics datasets and high-content immunology readouts, to facilitate the generation of comprehensive, integrated, and actionable data for our partners. eCRF solutions are implemented in our prospective studies to ensure the collection of quality data, the use of appropriate controls, and traceability. Personal data are shared with your team safely and confidentially using our secure solutions. Our processes are compliant with the standard methodologies of the French Data Protection Authority and GDPR.
- The provision of biobanking solutions for the secure storage of high-value samples collected through our collaborative projects. We offer efficient sample-tracking solutions through our Laboratory Information Management System (LIMS), within a high-quality ISO9001 standard environment.
Once collected and processed, samples are analyzed and characterized using our cutting-edge technologies, in order to answer questions, in the four principal fields of applied microbiology : Vaccines, Diagnostic, Microbiota, and Antimicrobials.