The FDA issued its Framework for the Use of Digital Health Technologies in Drug and Biological Product Development earlier this year, representing the agency's road map on the topic. Digital health technologies (DHTs) may include wearable, implantable, or software applications, among other approaches. This article takes a closer look at the framework as well as related FDA efforts this year.
- Establishing TMF Quality Goals For Greater Trial Efficiency
- RBQM Adoption: Current Use, Overcoming Barriers, And Anticipating ICH E6 (R3)
- How To Accelerate Digital Clinical Transformation Through A Holistic Approach
- Embracing Hybrid Trial Design — How, When, & Why To Use It
- Using RWD For Rapid Signal Assessment: Current Gaps And Opportunities
- Safety-centric Monitoring: Measuring Safety Data In A Consistent And Standardized Manner
- Advancing Rare Disease Research With Patient Registries
- How PROs Enhance Patient Care Decisions And Future Clinical Research
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
Unlocking New Clinical Insights With Remote Captured Sleep Data
Physicians, researchers, and drug developers need better data on sleep but capturing rich, real-world data in formal clinical trials has been difficult. Gain insight into ways to start collecting quality sleep data remotely by leveraging cloud-based data ingestion and processing.
Gradually Investing In Direct Data Capture Is Inevitable
Given study decentralization and the many electronic sources of data now available, it is time for sponsors and contract research organizations to face the inevitable: EDCs need to be “sunsetted.”
SMART On FHIR: Auto-Populate eCRFs On Study Day 1
Get an overview of SMART on Fast Healthcare Interoperability (FHIR) for clinical trials, including workflow improvements, real-world data (RWD) integration, and reducing researcher burnout.
The False Economy Of Paper Diaries In Clinical Trials
While paper diaries may appear cheaper, but there are hidden costs that make a digital eCOA solution much more affordable in your clinical trial.
Nevro Eliminates Majority Of Source Data Verification With ePRO And EDC
Read how a global medical device company was able to unlock new efficiencies by implementing data collection via electronic patient-reported outcome assessments.
Considerations For Implementing The Best eCOAs In Your Trial Design
Dive into considerations when deciding on the best COAs to implement as well as best practices when developing your eCOA strategy in this blog.
eTMF Systems Tell Compelling Story Of COVID-19 Vaccines
The rapid development of Covid-19 vaccines may lead more drug developers to increase their speed and agility by adopting electronic Trial Master File (eTMF) systems. In the case of Covid-19 vaccines, discover how eTMF systems tell a dramatic tale.
Managing Clinical Trial Changes And Mid-Study Data Migrations
Explore how the Imperial College London was able to complete a successful migration of 14 ongoing studies, involving over 1,700 patients and 150,000+ forms, within a 16-month timeframe.
Automation Solutions For Safety Document Distribution
Discover how a leading global pharmaceutical company solved the problem of managed the distribution of safety reports by their clinical operations team.
Simplifying The Regulatory Submission Process With A Modern CTMS
Working in collaboration with industry representatives, explore the value that pulling the regulatory submission process into a modern Clinical Trial Management System (CTMS) could have.
ISR Reports recently conducted research to understand the pharma industry’s experiences with clinical technology providers. Based on their findings, they created Industry Perspectives On Clinical Technologies, an e-book that discusses characteristics to consider when selecting an IRT provider, why sponsors use more than one CTMS solution, the future of EDC, and more.Read The E-book!