CONTRACT RESEARCH ORGANIZATION (CRO)
Italian Medicine Agency
DataRiver is self-certified as Contract Research Organization (CRO) at Italian Medicine Agency (AIFA) for Clinical Data Management and Statistical Analysis in clinical trials, in accordance with the Italian Ministry of Health Decree DM 15/11/2011. DataRiver operates according to Standard Operating Procedures (SOP) in line with the standards for Good Clinical Practice (ICH-GCP).
UNI EN ISO 13485:2021 CERTIFICATION
Quality Management System for Medical Devices
DataRiver’s quality management system complies with UNI EN ISO 13485:2021 , the international standard for the medical device industry. This certification, issued by TÜV Rheinland Italia S.r.l., ensures full compliance throughout the software lifecycle, from design to post-market surveillance.
Adhering to this standard guarantees maximum reliability in SaMD (Software as a Medical Device) development, ensuring high clinical safety and risk management standards in full compliance with MDR (EU) 2017/745 regulatory requirements.
ISO/IEC 27001:2022 CERTIFICATION, ISO/IEC 27017:2015 AND ISO/IEC 27018:2019 GUIDELINES
Information Security Management System Certificate
DataRiver’s management system complies with the requirements of the ISO/IEC 27001:2022 standard, an international benchmark recognizing the implementation of an effective Information Security Management System (ISMS). The certification, issued by KIWA CERMET Italia S.p.A., integrated with the ISO/IEC 27017:2015 and ISO/IEC 27018:2019 guidelines, confirms the company’s commitment to protecting data integrity. Through a systematic and proactive risk management approach, we ensure the confidentiality, integrity, and availability of information, minimizing the risk of security breaches.
CONFINDUSTRIA DISPOSITIVI MEDICI
TRANSPARENCY OBLIGATIONS - CONFINDUSTRIA DISPOSITIVI MEDICI
Data are presented in aggregate form at this link.
The transfers were made in compliance with current tax regulations, currency in euro (€).
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IMI EHDEN CONSORTIUM
SME CERTIFIED BY IMI EHDEN CONSORTIUM
DataRiver is a certified SME by the IMI EHDEN consortium (https://www.ehden.eu/) for the support to healthcare facilities in the process of standardizing health data with respect to the OMOP Common Data Model standard and provide additional services in the EHDEN and OHDSI ecosystem.
DataRiver can support Data Partners who receive funding through the Data Partner call https://www.ehden.eu/data-partner-calls/
AICRO
DataRiver is a member of AICRO (Italian Association of Contract Research Organization) https://www.aicro.it/en/.
AICRO, member of the European Contract Research Federation EUCROF, operates in the field of applied clinical research with the aim of promoting the use of G.C.P. in clinical trials and other reference standards (GLP, GMP, etc.), ensure quality standards in the practice of members, represent member companies before regulatory authorities both nationally and internationally, promote training of personnel involved in clinical research and to collaborate with other competent authorities and/or recognized Orders and Associations in order to further develop clinical research, taking particular account of drug safety.
EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK (ECRIN)
DataRiver is a member of the European Clinical Research Infrastructure Network (ECRIN) https://ecrin.org/, not-for-profit organisation that supports the conduct of independent, multinational clinical trials.
DataRiver, as a member of the itaCRIN network (ITAlian Clinical Research Infrastructure Network), aims to make its contribution to supporting clinical research through its expertise in the development of hybrid and remote clinical trials, retrospective clinical trials involving the integration of data collected directly from clinical databases (such as EHRs, Hospital Information Systems, Pathology Registries, Laboratory databases), and its expertise in the field of Clinical Real World Data, Big Data Integration and Data Harmonization.
BI-REX INDUSTRY 4.0 COMPETENCE CENTER
BIG DATA
DataRiver is one of the founding members of the BI-REX (Big Data Innovation & Research EXcellence) Industry 4.0 Competence Center (https://bi-rex.it/en/home-page-eng/), a highly specialized competence center on Industry 4.0 technologies. DataRiver operates as a Technology and Service Provider, providing tools and innovative solutions in Big Data integration and analysis of the Industry 4.0 field.
EMILIA ROMAGNA HIGH TECHNOLOGY NETWORK
INDUSTRIAL RESEARCH LAB
DataRiver is accredited as an Industrial Research Lab of the High Technology Network of the Emilia-Romagna Region (https://www.retealtatecnologia.it/en)and is a founder member of the Emilia Romagna Clust-ER on “Health and Wellness Industries“, involving pharmaceutical companies, biomedical companies, universities, research laboratories and private enterprises and Clust-ER on “Service Innovation”, aimed at conceiving innovative services based on Big Data Analytics and IoT
INNOVATIVE SME
RESEARCH AND INNOVATION CENTER
The Company is registred as SME in the special section dedicated to innovative SMEs of “Registro Imprese”, the Italian Business Register.
DataRiver is also registered as a Research and Innovation Center (CRTT) at QuestIO (Quality Evaluation in Science and Technology for Innovation Opportunity), an instrument created by the Lombardy Region to promote the innovation ecosystem, intended as a combination of different subjects active in research and innovation.