• 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)
Provided by RARE DISEASE COHORTS (RADICO) / FRENCH NATIONAL PROGRAMME ON RARE DISEASE COHORTS
RaDiCo supports the implementation of national programs in any country that would need it, by sharing its expertise in database management and implementation of national cohorts on rare diseases. Beyond its own projects, RaDiCo promotes the commitment of French actors to European and international projects needing the implementation of borderless cohorts. We advise and support you for the setting up of propositions and for the management of your programs in this field..).
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• data centre certification program (audits European, non-commercial data centres using ECRIN IT/DM standards, to confirm their ability to provide compliant, effective, and efficient data management services for controlled clinical trials)
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PedCRIN developed a series of tools (WP3) and procedures to support the setup and the management of multinational neonatal and paediatric clinical trials in Europe. These tools are developed to train and support researchers and clinicians so they can establish, run, and manage both paediatric and neonatal multinational clinical trials in a more effective and easier way. The removal of barriers to trial management will speed up the evaluation of new and improved therapies.
Visit websiteProvided by EUROPEAN RESEARCH INFRASTRUCTURE ON HIGHLY PATHOGENIC AGENTS (ERINHA)
The services offered by ERINHA includea.o.
• Access to state of art European high containment (BSL4 & BSL3) and complementary facilities to advance research on high-consequence pathogens. In-vivo testing with a variety of animal models (including small rodents, ferrets, and non-human primates). In-vitro experiments using highly pathogenic agents with both in-person and remote access possibilities.
Mapi Research Trust’s PROVIDE services are a unique resource for the scientific community. This full-range support is critical for anyone involved in the field of Clinical Outcomes Assessments (COAs).
PROVIDE, which is available on an ad-hoc basis or within the context of annual subscriptions, includes the following in-house easily accessible services (non-exhaustive list):
Copyright for measures (who owns the measure)
Available translated versions & methodology to translate
Translation Certificates
Providing of scoring manuals
Licensing process / permission to use measures
Find measures in a specific therapeutic indication/on-going clinical trials
Original and review copies of thousands of COAs and translations
List of COA concepts
List of recommended COAs from guidelines
PRO Claims: a study of competitor products and COA Labeling claims
Provide reports that come from PROQOLID / PROLabels
Developer contact (for conditions of use, scoring, translation, etc.)
Bibliographic references
See content validity documentation, availability, psychometric properties, etc.
Provided by EUROPEAN RESEARCH INFRASTRUCTURE ON HIGHLY PATHOGENIC AGENTS (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
Provided by EURORDIS - EUROPEAN ORGANISATION FOR RARE DISEASES ASSOCIATION
* Mechanism of Coordinated Access to orphan medicinal products (MoCA): is a platform where companies’ issues around reimbursement or financing schemes can be discussed with a variety of jurisdictions and societal perspectives. It provides a mechanism for European countries to collaborate on coordinated access to orphan medicines in a voluntary, dialogue-based approach, intended to create a fluid set of interactions between key stakeholders, across all aspects of a product.
Visit websiteProvided by EUROPEAN RESEARCH INFRASTRUCTURE ON HIGHLY PATHOGENIC AGENTS (ERINHA)
ERINHA offers training for:
* Working safely in high containment laboratories
* General Biosecurity Training
* Operations of a Biosafety Laboratory
* Other trainings related to high containment research facilities
Provided by EURORDIS - EUROPEAN ORGANISATION FOR RARE DISEASES ASSOCIATION
*The EURORDIS Open Academy brings together all EURORDIS trainings with the goal of building the capacity of rare disease patient advocates.
Through the EURORDIS Open Academy capacity-building programmes, EURORDIS empowers patient advocates to have the confidence and knowledge needed to bring their expertise to discussions on health care, research and medicines development.
