Newsletter | November 24, 2021

11.24.21 -- 4 Factors Preventing Diversity In Trials -- And How To Overcome Them

Featured Editorial
Industry Insights
Meeting The Rising Challenge Of Software Training For Clinical Trial Sites

The need for technology has been trending upward for years, even before being vastly accelerated by COVID-19. As the progression of the digital age continues, technology and software have become not only the norm in our everyday lives but also the foundation upon which entire businesses and industries are built.

How Does Better Patient Engagement Become Better Study Insights?

This blog post describes how an interactive dashboard can help with monitoring and managing clinical trials.

Electronic Clinical Outcome Assessment (eCOA)/Electronic Patient Reported Outcome (ePRO) Landscape: COVID-19 Impact

Due to lockdowns or patient health concerns during the COVID-19 pandemic, patients were no longer able or willing to attend site visits. This led to questions from our sponsors regarding how we could collect site-based data from patients at home. Knowing that web-based data collection is the most desirable for ensuring patient safety and data integrity, we quickly came up with a solution for our clients.

Drug Repurposing Trends And Strategic Approaches For Shortening Timelines

As the complexity of drug development increases, so does the industry’s focus on strategies and solutions that can help bring advanced products to market as quickly as possible.

Preparing For A Risk-Based Future: What ICH Revisions Mean For Clinical Trial Design And Conduct

In a two-part series, this first paper outlines the quality and regulatory thinking that underpins risk-based quality management (RBQM) and details essential points of compliance for emerging ICH core guidances on RBQM — including ICH E8 (R1) and ICH GCP E6 (R3) — and offers further discussion of RBQM implications for sponsors, clinical sites, and patients.

Intelligent Automation For The Trial Master File (TMF) With AI-Driven Applications

At IQVIA, we recognize that the proof of a new technology’s useability occurs when we get past pilots and into production. An example of an in-production capability enhanced by artificial intelligence and used by over 6,000 employees across the globe in multiple languages today is our Intelligent eTMF application.

Back To Basics: 505(b)(2) FAQs Part 1

The topic of this post will be general 505(b)(2) questions, including what is and is not allowed for an approval via the 505(b)(2) regulatory pathway.

Transforming Procurement And Vendor Management In Life Sciences Companies

What if you could gain greater visibility and control of contract and project finances, with more management flexibility, by using standardized, cloud-based technology purpose-built for life sciences businesses? Read the available article to find out more.

An Advanced Design Framework For Clinical Development In The Era Of Cloud Computing

While the number of trial designs and types have gently expanded, finding the optimal trial design for a specific context remains an elusive goal. Cloud computing has altered the process of trial design by taking familiar techniques for simulation and modeling and generating thousands of different trial designs.

Swing Therapeutics Achieved 97% Patient Compliance With ePRO

Swing Therapeutics leveraged Medrio ePRO in a proof-of-concept for a decentralized hybrid study. Electronic patient reported outcomes (ePRO) technology was used to assess the results of varying digital therapies and the feasibility of conducting a largely virtual clinical study in a fibromyalgia population.

Gaining The Insight To Lead: Unlock Your Trial's Full Potential

With increasing pressure to deliver drugs to market faster and at lower cost, enterprise sponsors are in a race to derive better insights from data and analytics. Discover how to improve study success rates, optimize study design, accelerate enrollment, monitor performance against similar trials, and uncover issues for early remediation.

Changing Landscape Of Evidence Charting New Assessment Pathways

Judith Glennie, Global Forum regional editor for Canada, discusses the concept of health technology assessments (HTAs) and its place in the therapeutic development of pipeline products — first on a global basis and then within the context of Canadian and other international jurisdictions.

Strategically Controlling Clinical Trial Costs: 5 Big Takeaways

Ensuring that your trial is delivered with the highest of quality, on time, and on budget is essential with the escalating costs to conduct clinical trials and to avoid unnecessary and often required change orders. This infographic reviews five key takeaways for controlling clinical trial costs while building a focus on quality from the beginning.

Increase Recruitment, Retention, And Compliance With Engaging Site Training
Explore best practices for eLearning, training, and virtual engagement and examine the current state of site training, critical industry trends, and key strategies to implement at your organization.
eTMF Powered By AI: Automation Benefits And A Look At The Future

Watch the available webinar to find out solutions for how to continue to refine and improve the electronic trial master file’s (eTMF’s) ability to automatically classify documents.

Life Science Leader Magazine

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Check it out today for access to candid interviews with top-tier executives on how they do business.