MYHEALTH PLATFORM FOR CLINICAL TRIALS AND DICOM IMAGES MANAGEMENT
Clinical Image and Molecular Data Repository
MyHealth features a secure and validated web repository (Computer System Validation) for managing clinical documentation, integrating web viewing tools specifically for high-definition radiology (DICOM) and digital pathology (WSI) diagnostic clinics, and produces quality reports on genomic data (FASTQ).
The platform allows you to upload entire files or folders, search and filter by file type, and supports customizable workflows for data anonymization and image processing.
For Radiology: the integrated web viewer has advanced features, including anatomical measurements and fine-tuning of brightness and contrast. It can generate 3D reconstructions from 2D DICOM series, and allows for simultaneous spatial assessment thanks to multiplanar navigation (axial, coronal, and sagittal planes).
For Digital Pathology and Histology: the viewer enables smooth, latency-free image exploration (deep zoom and pan), supported by a preview map for spatial orientation. Thanks to its vendor-neutral architecture, the solution is fully compatible with major Whole Slide Imaging formats, both standard and proprietary (including Hamamatsu, Leica, Philips, Aperio, and generic TIFF).
For genomic data, the system automatically performs quality control (QC) on the sequence. This process generates a detailed report that allows operators to immediately evaluate key metrics, assessing the integrity and quality of the material.
Clinical Natural Language Processing (NLP)
The repository integrates a clinical NLP engine for data extraction from unstructured data, such as clinical notes, mission letters, laboratory and radiology reports, extracting key information to accurately automate the completion of structured fields within eCRFs managed by the MyHealth platform.
Clinical Trials on Drugs, Medical Devices & Food Supplements
DataRiver has developed the “My Health eCRF” Web and Mobile Platform, for the management of clinical trials of Phase I – IV drugs, observational studies and trials on medical devices.
The My Health platform is validated (Computer System Validation) according to international standards and guidelines for clinical trials: ICH GCP, 21 CFR part 11 and IT security: OSSTMM, OWASP, NIST 800-115, ISO-IEC 27: 000 2016, ISO / IEC 27001: 2017, ISO / IEC 27002: 2013.
My Health eCRF allows to have a unified and complete view of information relating to patients enrolled in clinical trials, integrating the data collected through:
– a validated eCRF system for the management of Phase I – IV and observational clinical trials on drugs and clinical trials on medical devices
– app for administering patient questionnaires via smartphone and tablet
– wearable devices and sensors worn by patients to collect data on physical activity and rehabilitation performed
– medical devices for the collection of physiological parameters
- DICOM image management (including CT, MRI, ultrasound, X-ray, and PET)
MyHealth eCRF allows to optimize and reduce the workload of clinical centers during the course of the clinical trials through the use of several digital tools including an electronic informed consent management system and an eTMF system.