Real World Data

The software solutions developed by DataRiver for clinical data management combine the most advanced technologies in Big Data Integration & Harmonisation and Real World Data (RWD) management. This enables clinical trialists and hospital managers to attain a unified and comprehensive view of patient information contained in various clinical and administrative databases, such as electronic health records (EHR), pathology registries, laboratory databases, eCRF systems for clinical trial management, pharmaceutical prescriptions and hospital discharge forms.
The integration and harmonisation of the clinical Big Data contained in the various hospital databases makes it possible to analyse a large amount of data related to a specific pathology, contributing to the improvement of clinical research, assessing the safety and effectiveness of interventions in normal clinical practice and providing support for the planning of personalised care pathways.

WHO IS IT FOR?

PHARMACEUTICAL SECTOR, BIOMEDICAL, INDEPENDENT CLINICAL RESEARCH

The correct use of the great potential provided by Real World Data (RWD) allows Hospital Managers and medical staff to acquire new information on patients to support diagnostic/therapeutic decisions, by integrating and analysing the data on a specific pathology contained in the various hospital databases with data and information collected directly from patients through the use of medical devices, wearable devices and the administration of ePRO.
The standardisation of clinical data in a shared format allows hospitals to further boost clinical research, enabling the promotion of international observational retrospective studies involving multiple clinical centres around the world, and making it possible to achieve a greater quantity and quality of data to be analysed in a specific pathology. The sharing of Big Data on a specific pathology among clinical facilities enables improved outcomes and a refinement of treatments and therapies.

Real World Data Standardization

DataRiver is a certified SME by the IMI EHDEN consortium (https://www.ehden.eu/) to support clinical and healthcare facilities in the process of standardising clinical data against the OMOP common data model and in the adoption of the main clinical data coding standards (ICD10, ICD-O-3, SNOMED, MedDRA). The standardisation of clinical data is an indispensable step in understanding Real World Data, interpreting its meaning, improving the results of translational research and providing additional support for decision-making leading to improved patient care. The ability to produce harmonised data according to international coding and standards is a prerequisite for participating in international clinical trials based on Real World Evidence (RWE).

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Development of retrospective clinical trials

DataRiver’s software solutions enable the development of retrospective observational clinical studies, making it possible to integrate, in an anonymised form, data collected in electronic health records, clinical registries, outpatient databases, laboratory databases, biobanks and clinical trial management systems used by hospital clinical facilities.
These type of studies make it possible to obtain more information and data on the effectiveness of therapies and patient care by exploiting the potential of the data already available in the various databases.

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Development of Hybrid & Remote Trials

DataRiver’s software solutions enable the development of patient-centred clinical trials, enabling patients’ physiological parameters to be monitored remotely through medical devices, and data to be collected on patients’ physical and rehabilitation activity through sensors and wearable devices. The software applications also allow the collection of ePROs, the use of a direct doctor-patient communication channel via ChatBot and Vocal Assistant, and the management of an electronic informed consent tool, thereby enabling the clinical centre to remotely monitor patients.

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RELATED TOOLS

The tools

MOMIS Dashboard

Mobile and Web Application allowing real-time viewing and monitoring of clinical trial data conducted and managed on heterogeneous software platforms