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
ON-DEMAND WEBINARS
Explore several elements of modern software development concepts and they’re transforming the IRT platform and user experience.
With so many moving parts in a clinical trial, why worry about the technology that is supposed to help manage it? In this webinar, explore five actionable and necessary strategies to leverage RTSM to simplify clinical trial operations.
While the digital transformation of clinical trials has made tremendous strides in recent years, the plethora of new technologies can overwhelm. Learn how to help sites and sponsors combat the overload of technology.
Explore how CTMS capabilities can help uncover hidden study risks with industry-standard questions in the CTMS library, score study risk based on likelihood, impact, and detectability, and manage key risk indicators.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![DreamStation]( "Unlocking New Clinical Insights With Remote Captured Sleep Data")
Unlocking New Clinical Insights With Remote Captured Sleep DataPhysicians, 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.
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![GettyImages-1447084050 data]( "Gradually Investing In Direct Data Capture Is Inevitable")
Gradually Investing In Direct Data Capture Is InevitableGiven 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.”
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![GettyImages-1383963898 AI Data]( "SMART On FHIR: Auto-Populate eCRFs On Study Day 1")
SMART On FHIR: Auto-Populate eCRFs On Study Day 1Get an overview of SMART on Fast Healthcare Interoperability (FHIR) for clinical trials, including workflow improvements, real-world data (RWD) integration, and reducing researcher burnout.
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![GettyImages-1170544407 doctor value]( "The False Economy Of Paper Diaries In Clinical Trials")
The False Economy Of Paper Diaries In Clinical TrialsWhile paper diaries may appear cheaper, but there are hidden costs that make a digital eCOA solution much more affordable in your clinical trial.
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![GettyImages-1355941377 source data]( "Nevro Eliminates Majority Of Source Data Verification With ePRO And EDC")
Nevro Eliminates Majority Of Source Data Verification With ePRO And EDCRead how a global medical device company was able to unlock new efficiencies by implementing data collection via electronic patient-reported outcome assessments.
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![GettyImages-1302453801 trial design ps]( "Considerations For Implementing The Best eCOAs In Your Trial Design")
Considerations For Implementing The Best eCOAs In Your Trial DesignDive into considerations when deciding on the best COAs to implement as well as best practices when developing your eCOA strategy in this blog.
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![GettyImages-1311429557-vaccine-shot]( "eTMF Systems Tell Compelling Story Of COVID-19 Vaccines")
eTMF Systems Tell Compelling Story Of COVID-19 VaccinesThe 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.
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![GettyImages-1355432264 data]( "Managing Clinical Trial Changes And Mid-Study Data Migrations")
Managing Clinical Trial Changes And Mid-Study Data MigrationsExplore 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.
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![Actionable Insights For The Pharmaceutical And Biotech Industry]( "Automation Solutions For Safety Document Distribution")
Automation Solutions For Safety Document DistributionDiscover how a leading global pharmaceutical company solved the problem of managed the distribution of safety reports by their clinical operations team.
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![GettyImages-1333253892-doctor-legal-regulatory]( "Simplifying The Regulatory Submission Process With A Modern CTMS")
Simplifying The Regulatory Submission Process With A Modern CTMSWorking in collaboration with industry representatives, explore the value that pulling the regulatory submission process into a modern Clinical Trial Management System (CTMS) could have.
FREE E-BOOK
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.
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