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Harvard Precision Medicine 2021 Conference | Examining Racial Bias in AI

Reading Time: 2 minutesMedidata Acorn AI’s Ana Fernández Oromendia, PhD spoke on a panel for Harvard’s Precision Medicine 2021 Conference, focusing on race and ethnicity. In particular, the conference looked into how race and ethnicity both inform and bias precision medicine diagnostics and therapeutics. In this panel, Oromendia spoke with Emma Pierson, PhD, Assistant Professor at Cornell and […]

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Rave Imaging Hits a Milestone: Supporting More than 1,000 Clinical Trials

Reading Time: 3 minutesRave Imaging, Medidata’s secure clinical trial imaging management platform, just hit a major milestone. The technology has been used to support more than 1,000 clinical trials globally. Since hitting the market in 2009, Rave Imaging has served to re-engineer clinical trial image management. Built on the Medidata Clinical Cloud, the technology provides unprecedented real-time visibility […]

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Modernizing Clinical Data Transformation to Accelerate Study Close and Kick-start Analysis

Reading Time: 3 minutesClinical data transformation is a key process to enable the analysis of clinical trial data. Transformed data powers both single and cross-study analyses. In addition, it also unlocks the ability to use historical trial data to generate an external control group or Synthetic Control Arm (SCA) in new studies—replacing the need to recruit patients into […]

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Making Therapies Safer with Clinical Trial Adjudication

Reading Time: 4 minutes Good drug and device safety is the bedrock of good clinical development, and that means keeping a meticulous catalogue of clinical events. To know whether your therapy or treatment works as intended, you must know with absolute precision how large numbers of individual patients respond to it. But how do you decide with certainty whether […]

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Origin Story: The Rise of Clinical Endpoint Committees

Reading Time: 3 minutesClinical endpoint committees (CECs) were first conceived in the 1990s by a pair of academic cardiologists to better manage and vet all of the clinical events data being produced by the increasing volume and complexity of clinical trials.1 Duke University professor of cardiology, Robert Califf, M.D. and Kenneth Mahaffey, M.D., Vice Chair of Clinical Research […]

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The Digital Solution to Clinical Event Adjudication

Reading Time: 3 minutesComplex clinical trial data management challenges demand quality digital solutions. So it’s no surprise that digital processing is increasingly recognized as the most efficient and reliable way to manage clinical endpoint adjudication by committee (CEC). In fact, in 2016, a joint industry-regulatory body that oversees pharmaceutical development known as the The International Council for Harmonisation […]

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Decentralized Clinical Trial Data Flow Maps | Association of Clinical Research Organizations

Reading Time: 2 minutesThis blog was authored by Fiona Maini, Global Compliance and Strategy Principal, and Valeria Orlova, Global Compliance and Strategy Analyst. As decentralized clinical trials (DCTs) are becoming increasingly more abundant, there is still a need for higher transparency in the industry concerning the digital format of clinical data. From the traditionally paper-based conduct of clinical […]

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What Sponsors Need to Know About Using Sensors in Decentralized Clinical Trials

Reading Time: 3 minutesWhen it comes to clinical trials, data is king—so it may come as little surprise that life sciences companies are always looking at ways to incorporate clinical trial technologies that increase the amount of data collected. Wearable sensors in clinical trials, as well as other remote data capture devices, are key parts of gathering more […]

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Diversity in Clinical Trials: The Need to Recruit More Ethnically Diverse Patient Populations

Reading Time: 4 minutes This blog was authored by Fiona Maini, Global Compliance and Strategy Principal at Medidata. The COVID-19 pandemic represented a turning point for healthcare. This situation prompted a rapid shift of resources and services to help maintain and control the virus, as well as a necessity for innovation accelerating the pace of change in the […]

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What Sponsors and CROs Are Demanding from Decentralized Clinical Trials

Reading Time: 4 minutesOne top clinical research organization (CRO) says that around 70% of all the clinical trials they conduct involve at least one aspect of a decentralized clinical trial (DCT). And that number may be conservative given that the COVID-19 pandemic has highlighted—and in many cases, necessitated—elements of DCTs and their benefits for conducting clinical trials for […]

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The Medidata Way: Committed to Trust and Transparency in Clinical Trials

Reading Time: 2 minutesTrust. It’s a simple concept that can be hard to define. And too often when life sciences companies talk about trustworthiness, it’s because theirs is in question. Medidata Approaches Trust Differently At Medidata, trust is at the core of every decision we make, because trust is the foundation of every successful relationship—be it personal or […]

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Medidata and Quanticate Talk Clinical Data Management and Technology in Clinical Trials

Reading Time: 3 minutes Medidata has been partnering with Quanticate, a leading, global biometric clinical research organisation (CRO) for over a decade—supporting the company in the adoption and successful use of a variety of Medidata’s technologies such as Rave, randomization and trial supply management (RTSM), and electronic patient-reported outcome (ePRO). We sat down with Claude Price, Director of Clinical […]

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