Transform Real World Data Collection for Clinical Trials and Research Studies

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A Google Cloud implementation partner for the FDA MyStudies Platform

We built the FDA MyStudies platform.
Since the launch, we have gained insights into delivering successful engagements along the way. We continue to work with Google and the FDA to make it easier for organizations to enrich their RWD collection efforts.

Work with BTC to realize the full
potential of the FDA MyStudies Platform

Faster 'time to market'. Secure and compliant deployment. Repeatable.

  • Creating branding for the mobile app(s) and across the platform.
  • Publishing the mobile app(s).
  • Deployment of GCP components.
  • Installing and configuring MyStudies platform on GCP.

Customization and enhancements to meet your study requirements.

  • Reusable and extensible feature design.
  • Development, testing and release of customization or a new feature.
  • Faster delivery, fewer defects, and lower cost as we leverage our experience.
Testing-Services

Testing Services

  • Functional, technical, deployment, security and compliance testing.
  • Testing resources to ensure a stable and compliant deployment.
  • Faster time to go-live with standardized QA practices and automated test suites.

Managed Services for Google Cloud Components. Application Support Services.

  • Issue response and analysis, issue fixes, testing and deployment.
  • Maintenance, backup, compliance reporting.
  • Faster resolution of issues, ease of app upgrades.

Analyze the collected data. Gain insights.

  • Extract and combine data meaningfully across various data stores, both internal and external.
  • Build a data engine that churns out transformed data to be fed into analytics tools.

End-to-end Consulting

  • Business, compliance, and technical consulting services
  • Recommendations on infrastructure scaling, costing, and monitoring.

To support COVID-19 frontline workers, UNC in collaboration with Google developed 'Heroes Health' app built on the FDA MyStudies platform. The app collects real-world data to understand how to best support frontline workers’ mental health.

Read the case study

PRO data and mobile technologies are increasingly important.

Familiarity with wearable devices

Introduction of wearable devices and healthcare mobile apps has amplified the awareness and willingness to use mobile for recording and reporting of health data.

Increase in usage of mobile internet

Majority of these smartphone users rely on the device's internet data.

Increase in usage of mobile devices

77% of US adults own smartphones; it was 35% in 2011.

Current ePRO platforms are falling short of meeting needs.

Flexibility and customization

Companies want a platform which they can adapt to their requirements - in terms of customising instruments, integrating with existing systems and data sets.

Enterprise integration

Companies don’t want to have unique or siloed solutions for each study.

Ease of deployment

Companies intend to leverage cloud native technologies for their solutions - containerization, dynamic management, automation and orchestration.

FDA MyStudies on Google Cloud - a regulatory compliant platform for collecting real world data

Study Builder

Study configuration and content management

Participant Mobile App(s)

ePRO, PerfO collection.

Participant Manager

Support Participant enrollment.

Participant Datastore

Store participant PII, enrollment and consent information

Response Datastore

Stores response data, and participant activity data.

Originally built for the FDA, now available on Google Cloud.

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Realize significant benefits for your clinical trials and research studies using the FDA MyStudies Platform on Google Cloud

Enhanced study design and protocol development

  • Enables virtual trials.
  • Enhanced study design focused on patients.
  • Supports all decentralized RWD models.

Improved patient recruitment, enrollment and retention

  • Allows for innovative ways to capture patient data.
  • Improves intervention timelines leading to increased care.
  • Accelerates the process at every step of data collection.

Study Builder

  • Enable multiple types of studies with minimal software development.
  • Dynamically author content for every new study.
  • Allows for faster intervention in updating and releasing study instruments.

Standard framework for mobile apps.

  • ResearchKit (iOS), ResearchStack (Android).
  • Easy to customize and extend the app functionality.
  • Improved patient experience and flexibility in instrument design.

Patient-registry based approach to recruiting

  • More options for patients to find trials and engage.
  • Run multiple studies through one gateway app or a standalone one.
  • Easier administration, security and data access management.

Customizable multi-study platform

  • Customize content per study.
  • Easy to set up new studies and mobile apps.

Built-in security and configurable privacy controls

  • More safeguards in the ownership and management of study data.
  • Speedier enrollment via digital eligibility and electronic consent process

Existing and possible integrations with GCP services

  • Healthcare API - Integration / FHIR format.
  • BigQuery, Looker - Data Warehouse, Data Analytics and Visualization, AI & ML.
  • Google Kubernetes Engine - Scalable deployments.

For FDA MyStudies and More

Digital & Tech. Strategy

  • Digital and Technology Thought Leadership
  • Collaborative Digital, Technology Strategy and Solution Architecture
  • Product Roadmapping

Technology Development

  • Technology Development and Delivery
  • Program Management and Delivery Oversight
  • Augmenting Execution Teams
  • Execution through our US and Global Centers.

Managed Services

  • Platform Customization and Functionality Extension
  • Infrastructure Setup and Validation Support
  • Platform Deployment, Validation and Launch Support
  • Infrastructure and Platform Maintenance and Support.

Your healthcare program deserves
all the advantages that digital technology delivers.