Turning Points: The ERT Blog

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Why Your Company Is Not Too Small for eCOA in Clinical Trials

This blog demystifies some of the common assumptions about using electronic clinical outcomes assessments in clinical trials, and presents the core advantages to all clinical trial sponsors & CROs, regardless of their size.

Improving the Clinical Trial Patient Experience through Voice Assistance

Here we present how voice assistant technology can simplify patients’ participation in clinical trials and review the findings of a study that evaluated its ability to capture important study information and enhance participants’ experiences during clinical trials.

Documentation in Imaging Clinical Trials: Its Importance and Recent Regulatory Changes

This article provides an overview of why documentation is critical to the success of medical imaging in clinical trials and summarizes a few key terminology updates resulting from the recent FDA Guidance for Industry with respect to clinical trial imaging endpoint process standards. Read this third installment to our medical imaging clinical trials series now.

3 Ways Sponsors benefit from using Voice Assistance in Clinical Trials

In this second installment to our series, we review three key ways in which clinical trial sponsors can benefit when using Voice Assistant (VA) technology in clinical research: expanding patient recruitment, increasing patient retention, and improving data quality.

10 Steps to Implementing Electronic Data Capture in Clinical Trials

Moving from paper to electronic data collection can seem like a daunting task. However, with proper, early planning and the right resources in place, sponsors and CROs of all sizes can cost effectively implement and benefit from an eCOA strategy in their trials. Learn how here.

Overcoming Data Management Complexities in Medical Imaging Clinical Trials

This second installment to a series on medical imaging in clinical trials reviews the data management considerations clinical trial sponsors should keep in mind as they plan and conduct clinical trials with imaging endpoints.

Improving Clinical Research through Voice Assistance

The use of Voice Assistants (VA) in clinical research presents a wealth of benefits for all clinical trial stakeholders, including patients, sponsors and research sites. This first installment to a series on the role VA can play in improving clinical research provides a background on the growing adoption of smart speakers and why they are grabbing the attention of the pharmaceutical industry.

Understanding the Blinded Read: Clinical Trial Imaging Series, Part 1

This first installment to a series on medical imaging trial design reviews why the blinded read is so important and how the various read categories and methods can impact your clinical trial data.

Improving Clinical Trial Data Quality through a Scalable Data Platform

Learn how a modern, cloud-based data platform that ingests any type of data from any source, and structures it for centralized trial monitoring and reporting to deliver real-time analytics enables you to keep clinical trials on track and on budget.

Why Early Phase Cardiac Safety Assessment Makes Good Business Sense

Learn how determining the cardiac safety profile of your compound by assessing QT during routine Phase I studies enables you to make go/no-go decisions sooner, better prioritize your drug development pipeline, and appropriately resource or refocus programs exhibiting potential cardiac safety issues.

Four Steps to Implementing Risk-based Quality Management

Learn how a Risk-based Quality Management (RBQM) approach to trial management ─ including technology that integrates data from multiple sources for real-time decision making ─ helps sponsors and CROs mitigate clinical trial risks before they become costly problems.

Navigating the Response Assessment Criteria for Lymphoma

Learn how recent changes to the standard treatment response criteria used in lymphoma clinical trials ─ including new biomarkers and different imaging methods ─ are enabling more accurate and effective patient assessment and management.

How to Improve Respiratory Data Quality in Non-Respiratory Clinical Trials

The biopharmaceutical industry invests billions of dollars annually into clinical research to address a range of debilitating respiratory conditions as well as non-respiratory indications with lung safety and disease progression endpoints. Here we discuss the ways in which pharma can improve the evaluation of respiratory endpoints to get higher quality data in non-respiratory trials.

Increase Clinical Trial Patient Engagement and Compliance with ePRO

This last installment in our series comparing electronic to traditional, paper-based data capture reviews how ePRO improves patient engagement and compliance during clinical trials.

Improving Efficiencies and Insights to Clinical Trial Performance Through eCOA: Part 2 of a Series

Find out how electronic data collection helps sponsors monitor patient safety and individual site performance – in real time – and improve clinical trial efficiencies. Read this second installment to our series on how sponsors and CROs of all sizes benefit from using eCOA instead of traditional, paper-based data capture.

What is eCOA and How Does it Improve Clinical Trial Data Quality?

In this first installment to a series on how clinical trial sponsors and CROs of all sizes can benefit from electronic data capture, we define electronic Clinical Outcome Assessments (eCOA) and give specific examples of the data quality advantages it delivers compared to the traditional, paper-based approach.

Applying FDA’s Clinical Trial Imaging Endpoint Guidance to Immuno-oncology Drug Development

Read how the FDA’s recently released Guidance on Imaging Endpoint Process Standards applies to the development of immuno-oncology drugs, i.e., precision medicine, and how clinical trial sponsors should align with the FDA’s Guidance to ensure collection of quality imaging endpoint data.

Five Reasons to Centralize ECG Data Collection /Analysis in Clinical Trials

Cardiac safety issues are among the most common reasons for promising drugs being halted in development and not brought to market. Learn five reasons why sponsors should centralize ECG data collection during clinical trials to protect their compounds and patients.

Why Wait? Assess Cardiac Safety in Phase 1 to Save Time and Costs

Clinical trial sponsors who take advantage of recent regulatory changes and conduct QT assessments during Phase 1 can confidently determine the cardiac safety profile of their compounds earlier, saving significant costs and time.

Expedite Clinical Trial Intervention Decisions: Investigative Site Optimization Series Part 4

This final installment to the Site Optimization Series focuses on how ePRO data collection delivers significant clinical trial cost and time savings by enabling investigative sites to expedite intervention decisions relating to patient compliance and safety.

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