Since the introduction of the new European Regulation 236/2014, some restrictions have applied to the traditional role of nonprofit foundations in the field of clinical trials, posing relevant limits regarding their possibility to conduct profit studies. In fact, at a European level, there is not such a distinction between profit and non-profit studies. This is the reason why Italian nonprofit organizations will have to come to terms with many constraints that may affect the way they can manage and conduct clinical trials.

To deal with such problems, EMN Trial Office (former EMN Research Italy) has been created. This company was founded in 2017 in Turin, and it is the first social company (from Italian jurisdiction “impresa sociale”) working in clinical research on multiple myeloma in Italy. Because of its nature, this social company is entitled to conduct profit studies, overcoming the limitations of nonprofit foundations in Italy. Consequently, results deriving from profit clinical trials can also be used by pharmaceutical companies to foster clinical research advances and to offer effective treatments to patients.

Various professionals have come together to create the EMN Trial Office in Italy: legal experts, labor consultants, accountants, as well as operative personnel already involved in the field of clinical trials on multiple myeloma. A distinctive feature of Italian social companies is that any profit derived from the conduction of clinical trials is not distributed to the company partners, but it is re-invested in the fundamental activities of the company, thus to further support clinical research.

EMN Trial Office

This department oversees the planning and execution of clinical trials, ensuring they are conducted effectively and in compliance with regulatory standards.

Clinical Trials Management

This department oversees the collection, management, and analysis of clinical data to ensure compliance and support pharmacovigilance activities.

Clinical Data Management

This department is responsible for the creation and management of medical documentation and clinical trial materials.

Medical Writing

This department manages the electronic Trial Master File processes and ensures compliance with regulatory standards.

eTMF Operations

This department is responsible for monitoring the safety of pharmaceutical products and ensuring compliance with regulatory standards.

EMN Trial Office

Org chart

Teams

Clinical Trials Management

Clinical Data Management

Medical Writing

eTMF Operations

Pharmacovigilance

Offices

EMN Trial Office

Org chart

Teams

Clinical Trials Management

Clinical Data Management

Medical Writing

eTMF Operations

Pharmacovigilance

Offices

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