Sponsor Efficiencies

November 8, 2023

Use of MSA Framework Enabled Improvements to Study Report Cycle Times

Featured Solution: Modernization of Statistical Analytics (MSA) Framework Improving Internal Processes “We’ve applied principles and concepts within TransCelerate’s ‘Modernization of Statistical Analytics (MSA) Framework‘ to improve our internal risk assessment process when it comes to using various statistical analytical tools. Our internal process to date was heavy on documentation and did not take a risk-based…

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May 25, 2023

Member Companies Using the QTL Framework Report Benefits in Process Efficiencies, Compliance, and More Proactive Actions

Featured Solution: Quality Tolerance Limits Framework Background In 2021, almost 60% of TransCelerate’s members denoted they had implemented* the “Quality Tolerance Limits (QTL) Framework.” Many members have reported examples of realized benefits to their clinical operations. Below are examples from four different member companies. Facilitates compliance with ICH E6 R2 “The solution offers the following…

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May 25, 2023

Sponsor leverages TransCelerate’s Protocol Deviation Toolkit to achieve a more optimal global process & improve the investigator site experience

Featured Solution: Protocol Deviations Toolkit “The TransCelerate Protocol Deviation Toolkit was leveraged to inform our strategy for a significant shift in our Protocol Deviation process. Although we did not participate in the workstream, it helped build a robust business case to secure internal commitment for the process improvement. Subsequently, the various components shaped the overall…

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July 15, 2020

TransCelerate’s Clinical Quality Management System: Issue Management (Paper)

Describes a framework for effective issue management within clinical development. Includes a suite of change management tools.

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July 15, 2020

RBM Interactive Guide

A multi-chapter, interactive guide to all risk-based monitoring components.

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July 15, 2020

TransCelerate’s Clinical Quality Management System: From a Vision to a Conceptual Framework (Paper)

Identifies methods for operationalizing in integrated QMS through which sponsors can systematically plan, control quality, monitor and improve performance in complex clinical research environments. Includes a suite of change management tools.

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July 15, 2020

Technology Considerations to Enable the Risk-Based Monitoring Methodology (Paper)

Lays out the high-level considerations when designing and building an integrated technology solution that will aid in scaling the methodology across an organization’s portfolio.

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July 15, 2020

Statistical Monitoring in Clinical Trials: Best Practices for Detecting Data Anomalies Suggestive of Fabrication or Misconduct (Paper)

Explores a a cross-functional, collaborative approach to statistical monitoring that can adapt to study design and data source and use a combination of statistical screening techniques and confirmatory graphics.

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July 15, 2020

Site Level Risk Assessment Considerations

Provides examples to help demonstrate possible alternatives for quantifying initial and ongoing site level risk.

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July 15, 2020

Risk-Based Monitoring Technology Considerations (Papers)

Two papers hat delve deeper into the technology considerations of RBM.

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