TURNING POINTS
See what we’re up to – and what we have to say – in today’s dynamic market.
50% OF ALL NDAs SUPPORTED SINCE 2014
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.
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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.
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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.
Read MoreHow 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.
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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.
Read MoreImproving 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.
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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.
Read MoreApplying 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.
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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.
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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.
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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.
Read MoreWhy Inject Additional Risks into Clinical Trials?
At a time when researchers are seeking to improve efficiencies in the clinical development process, it’s mind-boggling that some are still using outdated, and in many cases, manual approaches to collect, aggregate, and report clinical trial data. Here we present how automated, centralized solutions can streamline operations, improve study efficiencies and yield better results through two examples: electronic Clinical Outcome Assessments (eCOA) and advanced, technology-driven imaging.
Read MoreImprove Patient Recruitment and Retention in Clinical Trials: Clinical Site Optimization Series, Part 3
Effective patient enrollment and retention are critical to the success of clinical trials. In this third installment to the ‘Clinical Site Optimization’ series we examine how sponsors can succeed at keeping trials on track and on budget by arming investigate sites with electronic approaches to patient enrollment and data capture during clinical development.
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Expert Interview: The Benefits of Precise Cardiac Safety Testing in Phase I Clinical Trials
Read how recent regulatory changes are making it easier – and less expensive – for sponsors to confidently determine the cardiac safety profile of their drug candidates earlier in development.
Read MoreHow Personalized Medicine is Challenging Medical Imaging Teams: The Keytruda Example
With the 2017 approval of Merck’s Keytruda, the FDA has opened the door to novel oncologic treatments that truly are at the forefront of personalized medicine. In what is becoming a new era of cancer treatments, researchers must understand how to best design and operationalize an oncology trial to gain regulatory approval. Discover how this new treatment approach will drive big changes for oncologists, as well as for medical imaging teams.
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Train Investigative Sites Effectively: Clinical Site Optimization Series, Part 2
This second installment to our Clinical Site Optimization series examines how effective rater training in clinical trials plays a crucial role in improving clinical trial data quality and can help investigative sites succeed.
Read MoreImproving Clinical Trial Site Selection: Identify the Most Historically-productive Investigative Sites
This first in a series of blog posts shares practical, easy-to-implement strategies that help investigative sites succeed – and can have dramatic and immediate impacts on a clinical trial. Here, we examine how to leverage historical data across multiple sponsors to identify the most productive sites.
Read MoreImproving Efficiencies and Data Quality with an eCOA Platform in Vaccine Studies
Study teams conducting vaccine clinical studies face unique patient data capture challenges that conventional paper-based data capture methods are unable to resolve. Electronic clinical outcome assessment (eCOA) platforms are proving to be an effective alternative – helping study teams meet first-patient-in (FPI), improving data quality, and minimizing back-end costs. Read how electronic solutions are overcoming the data capture challenges of vaccine clinical trials.
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The Drive for Wearable Technology in Clinical Trials
Read how the use of wearable devices can help to improve trial efficiencies and what trial sponsors / regulators need to do to encourage their adoption in clinical research.
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Demystifying the New iRECIST Guidelines for Immunotherapy Clinical Trials
How should clinicians assess the progression of tumor size and the response to novel immunotherapeutic drugs in clinical trials? Read the blog to find out.
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