Expertise & support

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  2. Expertise & support
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Quality Management Services

Provided by EUROPEAN RESEARCH INFRASTRUCTURE CONSORTIUM (BBMRI-ERIC)

BBMRI-ERIC

Quality Management Services
– Knowledge Hub (Consulting on international standards relevant for biobanking and biomedical research; Quality management tasks in EU projects)
– Training & Support (In-house and online training, university courses, summer schools, short courses, workshops and consulting services covering various quality management systems relevant for biobanking and biomedical research )
– Auditing (The BBMRI-ERIC Self-Assessment Surveys (SAS) help to determine relevant requirements for work processes defined in international standards for biobanking and biomedical research). Audit programmes (Remote/on-site) (Quality check mark in Directory (assessment processes, including a remote or on-site audit, can lead to a Q-mark in the BBMRI-ERIC Directory))
– Quality assurance (define and provide biomarkers (intrinsic/ extrinsic) that allow standardized assessment of sample quality through engagement in biospecimen research.

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EORTC has developed a number of tailored tools and skills, enabling effective and qualitative management of increasingly diverse and complex clinical study data.
Clinical Trials tools, imaging tools, Molecular analysis tools, quality of life questionaires

Study tools


Our databases include information from multiple sources, including clinical, radiotherapy, diagnostic, molecular imaging and biological samples.

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Management of cross-functional projects

Provided by BIOTHERAPIES INSTITUTE

IDB

Managing cross-functional projects including:
Elaboration of non-clinical development plans in accordance with current regulations;
Coordination of the various stages of preclinical development with respect to timelines;
Identification of suppliers and the role of interface;
Establishment of budgets and allocation of resources.

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Clinical development and regulatory affairs

Provided by BIOTHERAPIES INSTITUTE

IDB

Clinical development and regulatory affairs: highly specialized expertise and experience for the conception, preparation and realization of clinical trials, in collaboration with hospital-based investigators, and conform to both French and international regulatory frameworks.

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Partnership and development

Provided by BIOTHERAPIES INSTITUTE

IDB

The Institute of Biotherapies is developing a partnership and valorization strategy which will allow it to take advantage of opportunities for co-development and co-exploitation.
Thus it has the following expertise which allow it to implement:
* An in-licensing strategy for technologies, savoir-faire and patents necessary for the development of projects for the Institute of Biotherapies;
* An out-licensing strategy for projects and technologies developed within the Institute of Biotherapies;
* A scientific and juridical expertise;
* An expertise towards transverse projects;
* A strategy for the development of international collaborations.

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Trial management support

Provided by EUROPEAN CLINICAL RESEARCH INFRASTRUCTURES NETWORK (ECRIN)

ECRIN

• trial management operations (interaction with competent authorities & ethics committees, project management, monitoring, vigilance, data management)
• clinical trial tools (outcome measures, regulatory database, site locations, risk-based monitoring)

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Transnational access Calls focussed on pathogenic agents

Provided by EUROPEAN RESEARCH INFRASTRUCTURE ON HIGHLY PATHOGENIC AGENTS (ERINHA)

Erinha

To facilitate Transnational access (TNA) to ERINHA’s member facilities, ERINHA periodically opens a call for applications. Free of charge TNA includes administrative & logistical support, remote use of ERINHA high containment facilities, and technical & scientific support.
Transnational Access is either:
– In person/on-site, and provided to selected Users that visit the facilities, on the necessary conditions that the users have appropriate background and successfully complete the required training
– Remote, through the provision of remote scientific services to selected Users
Note: Remote access will systematically apply for in vivo experiments

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