Harmonize Process

May 25, 2023

Advancing Maturity of Clinical Protocol Template Helps Reduce Protocol Development by 21%

Featured Solution: Clinical Protocol Template “We implemented the “Clinical Protocol Template (CPT)” across all interventional clinical studies at our member company. Using this template, our company has saved 168 hours in protocol development time (i.e., cycle time/effort from receipt of a governance-approved core protocol—pre-cursor to the protocol—to protocol approval). The decrease in time and effort…

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July 15, 2020

eSource Site Capability Questionnaire

Used by sponsors to help capture the site’s use of technology during the site qualification process. Intent is to facilitate the reduction of any administrative burden on sites by collecting information in a consistent manner.

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July 15, 2020

Issues Related to Non-CRF Data Practices (Paper)

Practices and procedures for the collection and retention of non-CRF data are crucial to maintaining data accuracy and integrity. To guide the development of such practices and procedures, this paper outlines certain high-level best practices related to handling and managing non-CRF data.​

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July 15, 2020

Optimizing the Use of Electronic Data Sources in Clinical Trials, The Landscape, Parts 1 & 2 (Papers)

These landscape assessments provide insight into sponsor company eSource activities and the environment affecting eSource adoption based on input from TransCelerate Member Companies, standards organizations, and regulatory authorities.

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July 15, 2020

Common Statistical Analysis Plan (SAP) – Basic Word Edition

Document template with common structure and proposed model content, aligned with ICH E9. Integrates with CPT and CSR templates.

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July 15, 2020

Technology Considerations for Enabling eSource in Clinical Research: Industry Perspective (Paper)

Provides insights into the technological complexities, operational scope, and the actions required from pharmaceutical industry stakeholders to adopt the eSource framework for clinical research at scale.

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July 15, 2020

Accelerating the Adoption of eSource in Clinical Research: A TransCelerate Point of View (Paper)

Provides a detailed assessment of the current state in the industry and opportunities to increase eSource adoption through four essential modalities.

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July 15, 2020

Common Protocol Template (CPT) – Basic Word Edition

Document template with a harmonized and streamlined approach to the format and content of clinical trial protocols. Includes common structure, proposed model content and participant and TA libraries.

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July 15, 2020

Clinical Template Suite Implementation Toolkit

A set of tools to enable assessment and adoption of the Clinical Template Suite.

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July 15, 2020

CSR Considerations for Studies Disrupted by the COVID-19 Pandemic

Identified the important topics for clinical researchers and research sponsors to consider as they adapt their studies and clinical study reports to disruptions caused by COVID-19.

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