ABOUT YPRIME

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/.

FEATURED PRODUCTS

YPrime helps you decipher clinical trial complexity—delivering IRT solutions that anticipate the ever-evolving needs of the clinical development industry. Using our IRT platform, our clients can reduce the risks, burdens, complexities, workload, time and costs associated with managing all aspects of global patient randomization and clinical supply management.

YPrime’s eCOA platform features an exceptional user experience for sponsors, investigator sites, and patients. This advanced technology enhances clinical trial efficiency, increases site satisfaction, and improves patient compliance. YPrime’s eCOA platform ensures the delivery of cleaner data, streamlining the clinical trial data collection and approval process. Our platform delivers even the most complex protocol seamlessly. Developed to integrate intelligently with your other technologies, all modalities are available for site- or home-based trials.

CONTACT INFORMATION

YPrime

263 Great Valley Parkway

Malvern, PA 19355

UNITED STATES

Phone: 267-536-3329

Contact: Jennifer McAleer

FEATURED ARTICLES

  • 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 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.

  • The use of patient-centric technology, such as electronic clinical outcome assessment (eCOA) tools, are an important building block for collecting more reliable endpoint data. Although the benefits of technology-driven tools are clear introducing new technology to already busy sites can create additional challenges. Read how by anticipating, developing, and implementing comprehensive end-user education and support throughout a clinical research study, sponsors can minimize the burdens created by the introduction of new eCOA technology.

  • Researchers are increasingly exploring BYOD strategies and while trials have successfully deployed this model for studies collecting key endpoint data, some CROs and sponsors are still hesitant because of the absence of regulatory guidance and of the unknowns related to patient acceptance. Sponsors and CROs considering BYOD should evaluate a range of factors and it is recommended you seek regulatory input early and often to get advice and alleviate concerns before selecting an ePRO strategy. In this article, we discuss some of the key considerations for sponsors who are deciding whether a BYOD strategy is right for their trial.

  • Clinical trial patients face more burdens today than ever before but calculated, compassionate use of technology can ease participation for patients and their families, improving study recruitment and retention.

  • The COVID-19 pandemic created a watershed moment in the drug development industry, accelerating further exploration into the use of advanced digital technologies for decentralized, virtual, and patient-centric trials. Collecting clinical outcome assessment data electronically from patients is one tool that provides significant benefits by enhancing clinical trial efficiency, minimizing patient and site burden, and improving patient compliance. There are also significant complexities with planning and implementing an effective electronic clinical outcome assessment (eCOA) solution that delivers all the possible benefits and a sponsor’s device strategy plays a critical role in the success of a clinical study. Which device is better for collecting eCOA—a patient’s own device, known as bring your own device (BYOD), or a vendor provisioned device (PD)?

  • Adoption of data standards are necessary to underpin higher data quality, efficiencies and integrated applications across increasingly complex clinical research processes. The adoption of data standards for electronic Clinical Outcomes Assessments (eCOA), the fastest growing technology in the eClinical space is critical to ensure quality and efficiency in this rapidly evolving discipline. This webinar will focus on Clinical Data Interchange Standards Consortium (CDISC) standards across data collection, tabulation, analysis and submission.

  • The coronavirus (COVID-19) pandemic has had a profound impact on families, communities, industries, and economies and that impact may be felt for years. The disruption caused by it has necessitated significant changes to the way we work and live. Dorothy Brown interviews Donna Mongiello as they discuss how to adapt to crises that impact the industry and speed up the adoption of technological tools to meet current and long-term needs. Despite the pain and disruption that this pandemic has created, it has enabled an opportunity for drug developers to explore new patient-facing technologies. Watch the webinar to learn more.

  • Isn't it about time for a globally proven electronic clinical outcomes assessment (eCOA) technology that gives you peace of mind? One that provides a better user experience for patients, sites, and sponsors? YPrime's eCOA platform delivers even the most complex protocol seamlessly. Developed to integrate intelligently with your other technologies, all modalities are available for site- or home-based trials.

  • YPrime's software approach blends development and testing into an iterative process, for better efficiency, higher quality and reliability that impacts everything, from predictable delivery timelines to positive user experiences.

  • YPrime's DCF tool not only dramatically accelerates cycle times but improves data quality by eliminating the potential for manual data entry errors during study database updates. 

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.