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CTTI

Clinical Trials Transformation Initiative

Managing Data

How Much Evidence Is Enough? Research Sponsor Experiences Seeking Regulatory Acceptance of Digital Health Technology-Derived Endpoints

Posted on June 8, 2023April 6, 2025 by kristi.geercken@duke.edu

How Much Evidence Is Enough? Research Sponsor Experiences Seeking Regulatory Acceptance of Digital Health Technology-Derived Endpoints

Posted in Data Collecting and Reporting, Developing Novel Endpoints, Innovative Trials, Managing Data, Managing Data, Novel Endpoints, Publications, Regulatory Submissions + Approvals, Related: Developing Novel Endpoints, Study Design, Study Operations

From Ideas to Implementation: ETH Zurich Helps Researchers Leverage Digital Innovation to Build Actionable Endpoints

Posted on April 10, 2023April 7, 2025 by kristi.geercken@duke.edu

From Ideas to Implementation: ETH Zurich Helps Researchers Leverage Digital Innovation to Build Actionable Endpoints

Posted in Case Studies, Data Collecting and Reporting, Developing Novel Endpoints, Digital Health Technologies, Innovative Trials, Managing Data, Managing Data, Novel Endpoints, Regulatory Submissions + Approvals, Study Design, Study Operations

Small, But Mighty: How a Rare Disease Foundation Built Natural History Data to Accelerate New Therapies

Posted on March 8, 2023February 11, 2025 by kristi.geercken@duke.edu

Small, But Mighty: How a Rare Disease Foundation Built Natural History Data to Accelerate New Therapies

Posted in Case Studies, Data Collecting and Reporting, Digital Health Technologies, Innovative Trials, Managing Data, Managing Data, Selecting and Testing Digital Health Technology, Study Design, Study Operations

CTTI Considerations for Advancing the Use of Digital Technologies for Data Capture & Improved Clinical Trials

Posted on June 9, 2022February 11, 2025 by kristi.geercken@duke.edu

CTTI Considerations for Advancing the Use of Digital Technologies for Data Capture & Improved Clinical Trials

Posted in Data Collecting and Reporting, Digital Health Technologies, Innovative Trials, Managing Data, Managing Data, Resources, Selecting and Testing Digital Health Technology, Study Design, Study Operations

Clear Roadmap of Requirements Allows Roche to Speed Multiple Sclerosis App Development

Posted on October 27, 2021February 13, 2025 by kristi.geercken@duke.edu

Clear Roadmap of Requirements Allows Roche to Speed Multiple Sclerosis App Development

Posted in Case Studies, Data Collecting and Reporting, Innovative Trials, Managing Data, Managing Data, Site Planning, Study Design, Study Operations, Supporting Sites, Supporting Sites

Digital Health Trials: Recommendations for Managing Data

Posted on July 8, 2021February 6, 2025 by kristi.geercken@duke.edu

Digital Health Trials: Recommendations for Managing Data

Posted in Data Collecting and Reporting, Innovative Trials, Managing Data, Managing Data, Recommendations, Study Design, Study Operations

Digital Health Technologies Data Flow Diagram

Posted on June 7, 2021February 6, 2025 by kristi.geercken@duke.edu

Digital Health Technologies Data Flow Diagram

Posted in Data Collecting and Reporting, Innovative Trials, Managing Data, Managing Data, Resources, Study Design, Study Operations

Decision Support Tool: Real-Time Data Sharing with Study Participants

Posted on June 7, 2021February 6, 2025 by kristi.geercken@duke.edu

Decision Support Tool: Real-Time Data Sharing with Study Participants

Posted in Data Collecting and Reporting, Innovative Trials, Managing Data, Managing Data, Resources, Study Design, Study Operations

Investigator Experiences Using Mobile Technologies in Clinical Research: Qualitative Descriptive Study

Posted on February 12, 2021February 11, 2025 by kristi.geercken@duke.edu

Investigator Experiences Using Mobile Technologies in Clinical Research: Qualitative Descriptive Study

Posted in Data Collecting and Reporting, Digital Health Technologies, Innovative Trials, Managing Data, Managing Data, Publications, Related: Managing Data, Related: Selecting and Testing Digital Health Technology, Related: Testing a Digital Health Technology, Selecting and Testing Digital Health Technology, Study Design, Study Operations, Testing a Digital Health Technology

Table: Approaches for Safety Monitoring & Managing Safety Signals when using Digital Health Technologies for Data Capture

Posted on June 7, 2020February 6, 2025 by kristi.geercken@duke.edu

Table: Approaches for Safety Monitoring & Managing Safety Signals when using Digital Health Technologies for Data Capture

Posted in Data Collecting and Reporting, Innovative Trials, Managing Data, Managing Data, Resources, Study Design, Study Operations

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