Precision Digital Health created SUMMA™, a self-service Real-World Evidence platform, that delivers automation that helps transform the way companies conduct clinical research.
SUMMA™ is a configurable solution that allows researchers to generate new insights by integrating large disparate real-world data sources such as electronic health records (EHR), historical clinical trails data, EDC, eCOA, ePRO’s, claims data, disease registries, labs, medical devices, wearables, and Health IOT.
PDH technology and solutions reinforce the FDAs directive to employ RWD in order to improve efficiencies for clinical research, drug development and health-related outcomes.
“Digital Fingerprint” – Creating 360° clinical view of patients requires multiple data sources in near real-time to empower clinical decision making.
With the use of mobile health applications, medical devices and wearables, we create a longitudinal view of the patient with greater frequency, as well as visualize their journey over time.
Our solution enables clients to combine various data sources like wearables, sensors and medical devices with other clinical data to advance time to market in clinical research.
PDH’s end-to-end solution provides a patient-centric approach using medical devices and wearables:
Recent global events have underscored the need for better access and engagement strategies in clinical research and healthcare at large. Decentralized Trails provide a solution that adheres to social and health requirements and safety consideratioins without disrupting research progress.
Decentralized Trails increase engagement and broaden enrollment due to increased patient access. This model reduces patient, caregiver and researcher burden through the use of mobile devices:
PDH facilitates this model of remote data capture by developing a configurable solution to meet research protocol while maintaining the stringent regulatory compliance (FDA/GDPR) required in the clinical trials environment.
Patients move in and out of healthcare systems making it difficult to understand the longitudinal patient view. Key challenges in understanding the patient journey are real-time access to multiple data assets and complaint, secure linking of multiple patient health records.
PDH facilitates patient linking process meets regulatory compliance and mitigates any privacy risks through the de-identification of patient data and creation of a unique patient token. This process of “tokenization” eliminates patient identification, is IRB approved and meets both HIPAA and FDA requirements.
Linking patient data from multiple sources securely:
Given the volume and intricacies of disparate data sources, Machine Learning (ML) and Artificial Intelligence (AI) are necessary to reveal patterns in large, complex data not visible to the human eye.
SUMMA™ automates these advanced techniques across large volumes of linked data, leading to broader impact in less time to establish new patterns and insights for clinical discovery. These patterns can lead to more targeted outcomes while decreasing cost, time and resources.
SUMMA™ can effectively solve a variety of clinical challenges:
SUMMA™ enables the integration of large real-world patient data sources into one repository or Data Lake. The platform has the capability to ingest these RWD assets and standardization of these disparate data into a common data model (e.g. CDISC, OMOP).
What sets SUMMA™ apart from other data lake providers is the emphasis placed on data harmonization and curation with processes such as:
This configurable Data lake creates cohesiveness across entie organization by breaking down silos and supporting a “Center of Excellence” approach for uniform and accessible enterprise-wide data utilization.
Creating one central repository with automated functions allows for many operational efficiencies in an organization: