Thought Leadership
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Selecting an eCOA Vendor to Best Fit Localization Needs

One of the main challenges for pharma/biotech companies regarding clinical trials is prolonged eCOA study start-up.  It is paramount to choose the right eCOA platform for each study. Sponsors must consider the study’s specific needs, such as user-friendliness, compliance,...
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Clinical Outcomes Assessments (COAs) in Clinical Trials: Copyright and Licensing

Author: Maria Arnott and Corinne Shoch, COA/eCOA Licensing Management Team In clinical trials, it is usually necessary for sponsors to obtain permission to use copyrighted materials, such as clinical outcome assessments (COAs). The process to obtain these permissions is called...
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Localizing Platforms for Digital Health: The Importance of Post-Localization Context Review

In a landscape defined by continuous technological advancement, many organizations in the life sciences industry strive to increase audience engagement through digital modalities, such as mobile and web applications or web portals. Building a robust technological infrastructure...
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The Role of Artificial Intelligence (AI) in Clinical Outcome Assessments (COAs)

Written by Mark Wade, Global Practice Leader, COA SME. Abstract  Artificial Intelligence (AI) is the new frontier for content creation, reuse of language assets; saving time and effort in the curation of documentation. The widely adopted generative AI tools, such as ChatGPT...
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Harnessing the Power of Electronic Clinical Outcomes Assessments (eCOA) Technology

Introduction The question of leveraging digital technologies in rare disease studies with smaller patient cohorts is not one of ROI, but rather data integrity. When compared with traditional paper-based patient reported outcomes (PROs), data integrity is much more easily...
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The Role of Qualitative Interviews in Ensuring a Patient-Centered Approach to Clinical Trials

Author: Morgan Vlad-McCabe Clinical trials play a crucial role in advancing medical research and improving healthcare outcomes. Traditionally, they have primarily focused on objective measures and quantitative data to evaluate the safety and efficacy of treatments. In recent...
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The Future of eCOA and Wearable Devices

Electronic Clinical Outcome Assessment (eCOA) wearables have been a major player in the collection of large volumes of patient-reported data. With clinical research generating large and complex datasets at a rapid rate, the value of eCOAs is increasingly apparent, offering new...
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The C3 Summit: Boston Recap

The second event in our series of C3 Summits took place in Boston on May 16, 2023. We invited industry experts and leaders to discuss challenges, opportunities, and strategies in clinical trial diversity, centricity, and outcome assessments through the lens of real-world...
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Hearing the Patient Voice Through Technology and eCOA

The intrinsic value of the patient’s voice has been heard. Over the past few years, Notifying Bodies have been ‘vocal’ on their desire for Studies to be more patient centric and diverse. Clinical Outcomes Assessments (COAs), a scientific instrument/measure whose primary function...
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3 Benefits of Centralizing Global Content Solutions for Regulatory Teams

The regulatory landscape is continually evolving, prompting pharmaceutical companies to adjust their strategies to remain in compliance with existing requirements. Since the remote shift throughout the COVID-19 pandemic, regulatory teams have been gradually embracing digitization...
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Preparing Compliant eCTD Submissions in Asia

In May 2015, the US FDA published final and binding guidance requiring submission within 24 months of certain Common Technical Documents (CTDs) in an electronic format. This was ratified in 2017 and subsequently revised in February 2020 (Rev. 7). Currently, other notifying bodies...
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5 Common eCOA Migration Issues

With so many clinical trials now using COAs on electronic platforms, the practice of “migration” (transferring and adapting COAs for electronic use) has become more common than ever. Without careful implementation, one minor deviation can compound across many languages, leading...