Since 2006, YPrime has helped biopharmaceutical organizations expedite and improve the quality of patient and site management, clinical supplies, drug accountability and patient-generated data in their clinical development efforts. YPrime’s configurable and customizable IRT and eCOA platforms enable greater speed, precision and integration in clinical trial management. The company’s data services tools eliminate data silos and help sponsors bring together fragmented clinical research data into contextual and actionable information. For more information, visit https://www.yprime.com/.
Expert Screen Review Instead Of Mode Equivalence Testing: Who Are These Experts?
Electronic data collection is fast becoming the preferred method (versus paper) for capturing patient-reported outcome data in clinical trials. This transition necessitated expensive and time-consuming mode equivalence testing. But now, the process of “expert screen review” is being considered as a more efficient and less expensive alternative.
eCOA Trends To Watch
With acceptance of personal electronic devices (e.g., smartphones and tablets) by the public, the use of computerized systems to collect clinical outcomes assessment (COA) data in clinical trials is commonplace and becoming the preferred and recommended method. As the regulators continue to encourage its use in clinical trials, eCOA deployment will continue to evolve. Read more about hot eCOA topics that demonstrate the trend toward patient-centricity are described here.
5 IRT Trends To Watch
Next generation IRT continues to evolve from work horse to racehorse – with the power to keep pace with rising clinical trial complexity and efficiency demands. Following are five IRT trends and how they will affect the clinical trial landscape.
The Value Of Data Standards In Clinical Trials: The Time Is Now
On an organizational level, failure to establish data standards upfront makes it difficult – and in some cases, impossible to connect data across disparate systems for efficient study execution. The adoption of data standards are necessary to underpin higher data quality, efficiencies and integrated applications across increasingly complex clinical research processes. Continue reading to understand the history of data standards and where they are headed in the future.
2019 CDISC Interchange Highlights – Clinical Data Standards Are Here To Stay
The 2019 Clinical Data Interchange Standards Consortium (CDISC) Interchange recently took place in sunny San Diego. Read how the industry is continuing to change and is being shaped by new sources of data and technology.
Electronic Patient-Reported Outcomes (ePRO) Data Capture Contingency Planning: Web Platforms vs. Paper Back-Up
Ensuring data integrity during clinical trials requires contingency planning for a viable backup data collection strategy to use in the rare event data recording can’t be completed with the primary electronic mode of data collection.
How To Reduce Clinical Supply Expense Using An IRT System
Mismanaging clinical supplies can threaten study outcomes, bring studies to a halt, and even jeopardize a clinical research program. This article outlines a solid clinical supply management program, defines interactive response technology (IRT) and its role in clinical supply management, and explains how implementing it can reduce risks and costs.
Practical Considerations For Patient-Focused Data Collection In Oncology Trials
Read how new initiatives reinforce the importance of the patient’s voice, acknowledge the limitations of traditional approaches and build on the lessons that emerge from each new study.
An Overview Of The ICH E6 (R2) Guideline
While the revisions to the guideline mainly impact sponsors, technology providers and contract research organizations need to be aware of the changes and make adjustments to operational procedures, documentation practices, quality approaches and computerized system functionality.
eCOA Translations And Cultural Adaptation: Best Practices And Efficiencies
While translation and cultural adaptation are time-intensive and require domain expertise, there are emerging best practices that not only save time, but also eliminate unnecessary work and reduce risk of error and timeline delays. his webinar will discuss the process of translation and cultural adaptation to support eCOA implementation on a global scale.
Demystifying IRT Terminology Webinar
“Configurable” and “customizable” are two commonly-used descriptors for interactive response technology systems that support clinical trials. Interpretations of these terms can vary widely. This webinar discusses definitions and system functionality in the context of configurable and customizable and includes systems development life cycle (SDLC) methodologies, the impact on timelines and cost and common applications in interactive response technology system designs.
Demystifying IRT Terminology
Bryan Clayton, Vice President, Strategic Solutions, YPrime recently presented a webinar on IRT technology. This article recaps the discussion on IRT terminology, SDLC methodologies and how different approaches can save time, risk and cost.
Moving Clinical Trials To The Patient’s Turf: eClinical Technologies Make it Possible
Wearables and mobile devices are the tools behind a new kind of clinical trial. Read how when they are paired with complementary technology like eCOA, IRT and other eClinical systems it can drive patient-centric studies that also benefit sponsors and investigator sites.
Data Governance In The Clinical Trial Ecosystem
For biopharmaceutical sponsors, clinical trial data are both the greatest organizational asset and the greatest challenge. This paper discusses the principles of data governance and how they are used to build a business intelligence framework that advances data quality, acquisition, and integration to deliver actionable information for use across the drug development enterprise.
SCOPE 2019 Highlights – Beyond The Pilot, Moving Towards Implementation
Recently, nearly 2000 participants attended the 10th Annual Scope Meeting. Read the expert perspectives, insights gained from lessons learned and forward-looking predictions across 10 parallel tracks focused on functional areas and emerging disciplines within clinical development.