Expertise & support

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  2. Expertise & support
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Call for cohort proposal

Provided by RARE DISEASE COHORTS (RADICO) / FRENCH NATIONAL PROGRAMME ON RARE DISEASE COHORTS

Radico

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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Paediatric clinical trial management

Provided by PedCRIN

PEDCRIN

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.

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Clinical Outcome Assessments support services

Provided by Mapi Trust

MAPI trust

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.

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Mechanism of Coordinated Access to orphan medicinal products (MoCA)

Provided by EURORDIS - EUROPEAN ORGANISATION FOR RARE DISEASES ASSOCIATION

Eurordis

* 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.

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Training on translational medicine for patient advocates

Provided by EURORDIS - EUROPEAN ORGANISATION FOR RARE DISEASES ASSOCIATION

Eurordis

*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.

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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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Services to patients

Provided by EURORDIS - EUROPEAN ORGANISATION FOR RARE DISEASES ASSOCIATION

Eurordis

EURORDIS promotes the implementation of services adapted to the needs of people living with a rare disease and provides:
* Connect with a patient organisation
* Rare disease helplines: offer social, psychological and information solutions to people living with a rare disease.Specialised Social Services are instrumental to the empowerment of people living with rare diseases and essential to the improvement of their well-being and health.
* Find a specialised Social Service
* Medical expertise

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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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