Turning Points: The ERT Blog

50% OF ALL NDAs SUPPORTED SINCE 2014

TURNING POINTS

See what we’re up to – and what we have to say – in today’s dynamic market.

Clinical Trial Imaging: How to Manage Blinded Independent Central Reads and Independent Safety Committees

Here we review situations where regulators, based on elevated concerns for safety, request to have safety assessments collected by clinical trial imaging confirmed independently via BICR and/or a Data Safety Monitoring Committees (DSMC).

Capture High Quality Respiratory Data: Don’t Let Spirometers Get in the Way

Avoid spirometry equipment that gets in the way and ensures patients perform the required maneuvers effectively, so you get valid and reliable respiratory data to support every clinical trial, every time.

Wearables in Clinical Trials: Where we’re Heading

Wearables are improving the clinical trial experience for patients and satisfying the need to collect data for real-world use studies. In this interview, ERT’s Karin Beckstrom provides insight into how wearables are being used in clinical trials today, and what the future has in store.

Detecting Myocarditis in Oncology Trials with Imaging

Advanced imaging techniques can be used to assess for myocarditis (which has been reported with immune checkpoint inhibitors) before initiating cancer therapy, as well as for monitoring during and after treatment.

How to Reduce Clinical Trial Risk: Shift to Active Risk Management

Here we review how trial sponsors can achieve the highest quality data, study performance improvements, and significant savings throughout clinical trials.

Customizing Clinical Trial Imaging to Support a Claim: A Case Study

When it comes to clinical trial imaging, a one-size-fits-all approach just doesn’t work. Creative problem-solving and scientific expertise are critical to meeting each sponsor’s unique needs. Here we review how Medtronic captured the data they needed to demonstrate product superiority by relying on ERT’s advanced imaging technology and scientific expertise.

3 Strategies to Capture ~ 100% Acceptable Respiratory Data in Clinical Trials

Collecting ATS/ERS-acceptable data is a fundamental goal for any pharmaceutical company involved in respiratory clinical trials. Here we present the three strategies clinical trial sponsors can adopt to ensure their data meets regulatory standards and helps them achieve their clinical objectives.

Keeping Clinical Trial Patients Safe: Why you can’t rely on Automated ECG Machine Measurements

Here we explain why relying entirely on ECG machine QTcF measurements for clinical trial decisions may have critical consequences for trial integrity as well as for patient safety, based on a recently conducted comparison study.

Monitoring Cardiotoxicity in Clinical Trials through Imaging: Practical Considerations

Learn the potential treatment-related cardiovascular issues trial sponsors should consider when creating drug development plans and how the appropriate imaging endpoints can help to define CV risks in clinical development.

Using Cardiac Imaging to Identify Cardiovascular Treatment-related Effects during Oncology Clinical Trials

The importance of evaluating cardiotoxicity during the clinical development of therapeutic agents cannot be understated. In this first of a 2-part series, we review several imaging methods that can support cardiac safety endpoints in oncology clinical trials and how imaging core labs can assist trial sponsors in evaluating these advanced techniques for incorporation into study protocols.

Transforming Clinical Trials through the Power of AI

By making clinical trials more intelligent, optimizing end-to-end processes and delivering greater insight for smarter decision making, Artificial Intelligence (AI) has the power to transform the clinical trials industry. Learn how AI, machine learning and deep learning techniques can drive clinical trial efficiencies and help pharma bring new drugs and therapies to the market faster.

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.

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