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
How 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.
Read MoreComplying with Global ALCOA Requirements: Electronic Subject and Caregiver Training
Global regulators recommend assessment training for patients, caregivers and site staff as essential to improving clinical trial data quality. This is called out in numerous guidances, including global ALCOA standards. Read how providing this rater training via the same electronic devices that will be used for study data collection can help sponsors meet regulators’ expectations.
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Getting the Most Out of Rare Disease Research
The stakes are high in rare disease research. Significant unknowns, a limited and geographically dispersed patient population, and challenges regarding patient/caregiver data collection pose different pressures for clinical researchers. Read how proven tools ─ including effective data capture strategies ─ can help sponsors overcome these challenges and accelerate rare disease research.
Read MoreYes, We Can Innovate a Better Patient Experience!
By integrating varied mHealth data streams with eCOA data, researchers may gain improved visibility into the patient experience, which could fuel patient-centric development strategies and deliver real value to patients and their caregivers. Learn how effective collaborations are enabling pharma to innovate new data collection processes, benefit from better data and increased trial efficiencies, and ultimately, deliver improved patient healthcare experiences.
Read MoreThe Internet of Medical Things: Creating a 21st Century Experience for the Patient
Using readily available sensors, Wi-Fi connectivity and the ever growing adoption of smartphones, the IoMT is enabling healthcare professionals to solve real healthcare problems and providing deeper insight into conditions for payers and providers. Read how the IoMT can improve health outcomes for patients and ultimately reduce pressure on all healthcare stakeholders.
Read MoreCurious About your Clinical Trial Data Analytics? Overcoming the Top 3 Sponsor Obstacles
Clinical trial sponsors are responsible for patient safety, trial integrity, study oversight and vendor oversight. Each of these key accountabilities hinges on data ― quality data ― but it’s often difficult to know how data and processes measure up compared to other sponsors. Read this blog post as trial leaders discuss the three most common questions related to data quality and steps you can take to reduce risks and improve data analytics.
Read MoreWhat Do Patients Want When Interacting with eDiaries? Part 3: Humanizing eCOA Screen Designs
‘Thank you.’ Although we’ve all known the power of these two words since preschool, we sometimes overlook how important they can be in clinical development. Read this third installment to the series on patient preferences for collecting electronic clinical outcomes (eCOA), and how minor eCOA study design changes can go a long way toward improving patient engagement during clinical trials.
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What Do Patients Want When Interacting with eDiaries? Part 2: Improving User Interface
Top-down or Left-right? Underline or italicize? Believe it or not, these decisions about text layout could make a difference in how patients answer electronic diaries (eDiary) in a clinical trial. In this 2nd installment to the series, “What do Patients want when Interacting with eDiaries?” we present the small changes sponsors can make to an eDiary screen layout in order to improve the patients’ experience during a clinical trial.
Read MoreWhat Do Patients Want When Interacting with eDiaries? Part 1: Improving Study Design and Scheduling
This 3-part series explores the learnings from a survey of patient preferences regarding electronic Clinical Outcome Assessments (eCOA) in clinical trials. In this first installment, read how study design features and scheduling can help improve patients’ experiences and protocol compliance.
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Multi-Program Digital Health Platforms – What Are the Benefits?
The digital health industry is enabling patients to manage their health conditions better than ever before. But how do we ensure patients remain motivated and engaged through their entire healthcare journey? Read how long-term, sustainable digital health solutions can improve health outcomes for patients, and ultimately their quality of life.
Read MoreThe Current State of Clinical Trial Imaging
Pharmaceutical developers are increasingly asked by regulators to include imaging analysis when evaluating clinical trial data, which adds a whole new level of risk and complexity to clinical trials. Here, we present the rationale behind the utility of image analysis software to overcome the challenges of traditional clinical trial imaging so that sponsors can leverage this technology to position their trials for success.
Read MoreClinical Trials Today ─ and Tomorrow
ERT President and CEO Jim Corrigan sat down to speak with PharmaVOICE at DIA 2017. In the interview, he discusses the risks associated with clinical trials, highlights what’s needed to clear the hurdle of paper-based data collection in clinical research, and shares where the eClinical space will be five years from now.
Read More Optimizing Clinical Trial Sites for Peak Performance
Get insights on readily available approaches that enable trial leaders to get the most out of investigative sites and achieve significant cost, time and data quality benefits with minimal investment and disruption.
Read MoreDriving Insights to Action through Improved Trial Oversight
ERT Trial Oversight Product Manager Brion Regan discusses today’s improved trial oversight solutions and the benefits they deliver.
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Trends Driving the Global Adoption of eCOA Data Collection
Ron Sullivan, ERT’s Executive Vice President, eCOA answers questions about current eCOA trends and what we can expect from this valuable clinical research tool in the future.
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