Real World Data (RWD) - OMOP
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 principal investigator 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 (such as RedCap, OpenClinica and many others), pharmaceutical prescriptions and hospital discharge forms.
The harmonization of clinical Big Data in the OMOP COMMON DATA MODEL format (and in the main coding standards ICD-9,ICD-10, ICD-11, ICD-0 3, SNOMED, MedDRA) collected in heterogeneous hospital databases makes it possible to analyze a large amount of data relating to a specific pathology, contributing to the improvement of clinical research, evaluating the safety and efficacy of interventions in normal clinical practice and providing support for the planning of personalized treatment 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 clinical data harmonization according to OMOP COMMON DATA MODEL and for 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).
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.
Development of Decentralized Clinical Trials (DCT)
DataRiver’s software solutions enable the development of Decentralized Clinical Trials (DCT), 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.
RELATED CASES
Case Studies
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