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Automated Self-Service RWE Platform

SUMMA™

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.

Other Our Solutions

Real World Evidence (RWE)

Harnessing disparate data sources for patient-centric view

Patient Linking

Connecting the healthcare gaps with patient privacy in mind.

Medical Devices/Wearables

Window into real time patient health and lifestyle.

Advanced Analytics and Machine Learning

Revealing patterns unnoticeable to the human eye

Decentralized Trails

Promote convenience and accessibility while maintaining integrity and security.

Data Lake

Transforming your Data Swamp into Data Lake.

Real World Evidence (RWE)

By bringing together various real-world data sources such as ePRO, electronic health records (EHR), claims and medical device, PDH fosters advancement of clinical trail research. The ability to integrate and harmonize large disparate RWD sources is vital to uncovering the complete patient journey.

PDH supports the FDA’s call for “next generation” clinical research providing mechanism for lowering cost of drug development and expanding patient access to treatment.

Examples of SUMMA™ RWE uses:

Hybrid Trails
  • Connect historical patient data and multiple RWD sources
  • Increase enrollment breadth and depth of usable data
  • Lower costs for site and subject
  • Reduce overall patient burden
Feasibility
  • Expedite cohort building
  • Find the right patient without involving IT
  • Protocol manipulation “on the fly”
  • Efficiently adjust inclusion/exclusion criteria
  • Reduce manual coding and extensive download time
Synthetic Cohort
  • Increase patient treatment access
  • Elimate enrollment hurdles
  • Truncates timelines and lower costs

Medical Devices/Wearables

“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:

  • Cloud-based device authorization with automated data ingestion
  • Data captured remotely to supplement Decentralized Trails
  • Self-service device tracking
  • Increased site management

Decentralized Trials

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:

  • E-Consent/enrollment
  • Linking (through e-consent) to additional data sources
  • Capturing eCOA, ePRO
  • Device/wearables data

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.

 

Patient Linking

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:

  • Increases the volume of eligible patients
  • Enhances patient profile
  • Lengthen the historical patient timeline
  • Eliminates associated PHI risk

 

Advanced Analytics And Machine Learning

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:

  • Segmentation and risk stratification – timely, accurate, diagnosis and treatment
  • Identification of gaps in care among specific patient or physician segments
  • Disease progression, treatment pathways and patient utilization and costs
  • Feasibility studies in trial design and implementation

Data Lake

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:

  • Auto-cataloging
  • Auto-fill
  • Elastic search

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:

  • Reduced IT complexity and costs
  • Increased efficiency of internal resources
  • Self-service – putting the power in the user’s hands
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