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CTTI

Clinical Trials Transformation Initiative

Study Design

Assessing the Financial Value of Patient Engagement

Posted on December 10, 2020February 7, 2025 by Hannah Faulkner

Assessing the Financial Value of Patient Engagement

Posted in Patient Engagement, Patient Group Engagement, Publications, Related: Patient Group Engagement, Study Design

Orikami Efficiently Deploys Digital Biomarker App by Collaborating Across Providers, Patients, and Developers

Posted on October 15, 2020January 31, 2025 by dcridigital

Orikami Efficiently Deploys Digital Biomarker App by Collaborating Across Providers, Patients, and Developers

Posted in Case Studies, Developing Novel Endpoints, Innovative Trials, Novel Endpoints, Regulatory Submissions + Approvals, Study Design, Study Operations

New Resources for Designing and Running Master Protocols Webinar Slides

Posted on October 13, 2020February 6, 2025 by Hannah Faulkner

New Resources for Designing and Running Master Protocols Webinar Slides

Posted in Innovative Trials, Master Protocol Studies, Master Protocols, Related: Master Protocol Studies, Resources, Study Design, Study Operations

Development and Application of a Patient Group Engagement Prioritization Tool for Use in Medical Product Development

Posted on September 29, 2020February 7, 2025 by Hannah Faulkner

Development and Application of a Patient Group Engagement Prioritization Tool for Use in Medical Product Development

Posted in Patient Engagement, Patient Group Engagement, Patient Group Engagement, Publications, Related: Patient Group Engagement, Study Design

Public Web Conference Report: Stakeholder Engagement on ICH E6 Guideline for GCP

Posted on September 24, 2020February 5, 2025 by Hannah Faulkner

Public Web Conference Report: Stakeholder Engagement on ICH E6 Guideline for GCP

Posted in Ensuring Quality, Informing ICH E6 Renovation, Informing ICH E6 Renovation, Related: Informing ICH E6 Renovation, Resources, Study Design

Investigators from Multiple U.S. Organizations Collaborate on First Embedded Pragmatic Clinical Trial Using National Health Plans’ Data

Posted on September 1, 2020February 5, 2025 by Hannah Faulkner

Investigators from Multiple U.S. Organizations Collaborate on First Embedded Pragmatic Clinical Trial Using National Health Plans’ Data 

Posted in Data Collecting and Reporting, Electronic Healthcare Data, Electronic Healthcare Data, Innovative Trials, Press Releases, Related: Electronic Healthcare Data, Study Design, Study Operations

Master Protocol Design & Implementation: Charting Multi-Stakeholder Pathways to Success

Posted on June 25, 2020February 6, 2025 by Hannah Faulkner

Master Protocol Design & Implementation: Charting Multi-Stakeholder Pathways to Success

Posted in Innovative Trials, Master Protocol Studies, Master Protocols, Resources, Study Design, Study Operations

CTTI Novel Endpoints Interactive Selection Tool

Posted on June 24, 2020February 21, 2025 by Hannah Faulkner

CTTI Novel Endpoints Interactive Selection Tool

Posted in Developing Novel Endpoints, Innovative Trials, Novel Endpoints, Primary, Regulatory Submissions + Approvals, Resources, Study Design, Study Operations

Determining the Suitability of Registries for Embedding Clinical Trials in the United States: A Project of the Clinical Trials Transformation Initiative

Posted on June 22, 2020February 11, 2025 by Hannah Faulkner

Determining the Suitability of Registries for Embedding Clinical Trials in the United States: A Project of the Clinical Trials Transformation Initiative

Posted in Data Collecting and Reporting, Innovative Trials, Publications, Registry Trials, Registry Trials, Related: Registry Trials, Study Design

Quality by Design Documentation Tool

Posted on June 8, 2020February 10, 2025 by Hannah Faulkner

Quality by Design Documentation Tool

Posted in Ensuring Quality, Quality By Design, Quality by Design, Resources, Study Design

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