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Clinical trials are conducted around the world to evaluate the safety and efficacy of new drugs, devices, and treatments. These trials often involve participants from different linguistic and cultural backgrounds, making accurate translations essential for ensuring participant understanding and data quality. In particular, electronic patient-reported outcome (ePRO) and electronic clinical outcome assessment (eCOA) measures have …

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Growing up, I always questioned why I’d be going with my grandmother to my great aunt’s house to administer medication, multiple times a day. What was this medicine doing? Why did she need it? It wasn’t until well into junior high, that I learned the significance of the medication that she was taking. And how …

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The US Food and Drug Administration (FDA) has recently taken steps to promote the advancement of decentralized clinical trials (DCTs), recognizing the potential to improve patient access and participation. As the VP of Compliance at Datacubed Health, I would like to share our analysis of these developments and offer recommendations to sponsors, CROs, and sites …

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With decades of clinical trial experience, I have witnessed firsthand the impact that patient retention and compliance have on clinical trial success. In a world where trial costs continue to rise and timelines get tighter, the need for effective patient engagement strategies has never been more crucial. In this article, I will share some valuable …

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Identity lock in clinical trials is an approach that aims to improve patient engagement by building a strong sense of identity and connection between patients and their participation in the trial. Behavioral science is the root of this approach, which focuses on making the patient the hero of their story. Concept of identity lock The …

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Embracing New Horizons in Clinical Trial Technology As clinical trials continue to evolve, technology plays an increasingly important role in shaping the future of research. Innovations in technology enable more efficient processes, improved data accuracy, and also better patient outcomes. In this article, we’ll discuss the future of clinical trial technology compliance. And the potential …

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In this article, I will highlight the implications of this mandate on clinical trials. And delve into strategies that can help increase diversity. I will also explore the role of cutting-edge technologies like eCOA/ePRO, patient engagement, and televisits in making clinical trials more inclusive. FDORA: A Deeper Dive FDORA, or the Food and Drug Administration’s …

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Hybrid clinical trial designs have transformed the landscape of medical research. But what exactly is a hybrid clinical trial design? In this article, we’ll delve into this innovative approach and explore its advantages. Defining Hybrid Clinical Trial Designs In essence, a hybrid clinical trial design combines elements from traditional randomized controlled trials (RCTs) and virtual …

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Electronic data collection methods transform clinical trials. Two common methods are eCOA (electronic Clinical Outcome Assessment) and ePRO (electronic Patient-Reported Outcome). This article explains the differences between these methods and highlights the benefits of using electronic data collection over traditional paper methods. eCOA: An Overview eCOA stands for electronic Clinical Outcome Assessment. It is a …

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What is patient engagement? Discover the benefits to a true engagement platform for clinical trials.

Read moreWhat is Patient Engagement in Clinical Trials?