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Reading Time: 2 minutes Sponsors know that access to compelling and relevant evidence across the experimental and real-world is crucial to drug development, safety monitoring, and the improvement of patient outcomes. Unfortunately, a data silo exists that results in loss of time, suboptimal insights, and an increased burden to sites, patients, and sponsors. The linking of clinical and real-world […]

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Reading Time: 2 minutesWhile decentralized clinical trials (DCTs) have provided benefits for participants such as fewer trips to trial sites and for sponsors, a huge increase in the amount and speed of data collected, they bring new risks due to the amount of data collected, digital endpoints, and the need to adjust oversight of compliance and data integrity. […]

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Reading Time: 2 minutesWorld Heart Day, celebrated annually on September 29th, raises awareness about cardiovascular disease (CVD) and its impact on millions of lives worldwide. Created by the World Heart Federation, this day unites people globally to promote heart-healthy living and reduce the risk of CVD. The heart is the body’s most powerful muscle, about the size of […]

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Reading Time: 3 minutesClinical trials are becoming more complex and a confluence of forces—including greater emphasis on patient experience, increasing protocol complexity, and precise value differentiation—is accelerating this complexity. Trials have evolved to include an ever-expanding array of data sources, increased data volume and precision, decentralized clinical trials (DCT), and adaptive designs. These environmental and industry changes have […]

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Reading Time: 4 minutes Clinical trials have evolved rapidly over recent years. They now have highly sophisticated protocols and multiple divergent data sources, inordinate data volume, decentralization, and increasingly complex adaptive designs. These changes have led to significant clinical data management challenges because the data management technologies and processes have not progressed at the same breakneck speed. Clinical data […]

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Reading Time: 3 minutesThe rising complexity of clinical trials has created great challenges to their traditional clinical data management process. These challenges present new obstacles to clinical data management, but they also create the opportunity to apply risk-based quality management (RBQM) principles to clinical data management. Risk-based clinical data management (RBDM) has been rapidly expanding over recent years. […]

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Reading Time: 4 minutesCollectively, more than 7,000 rare diseases are known to affect greater than 400 million people globally, and yet, a recent analysis found that only ~550 FDA approved orphan products are available to treat rare diseases. This is not surprising given that the pharmaceutical industry traditionally sidestepped rare disease drug development due to multiple known obstacles […]

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Reading Time: 2 minutes Gaps between clinical trial data (CTD) and real-world data (RWD) make it hard to fully understand long-term outcomes and therapeutic efficacy. Data linkage methodologies bridge these gaps. Data linkage lets sponsors link CTD with RWD at the patient level across current and completed trials—regardless of consent method—in a privacy-certified, CRO-agnostic manner while supporting multiple de-identification […]

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Reading Time: 2 minutesData linkage is a cutting-edge innovation that unlocks a new frontier of enhanced evidence generation by linking clinical trial data (CTD) with real-world data (RWD) at the patient level. Pharmaceutical companies seeking to build infrastructure for data linkage must make decisions early on to avoid pitfalls that can limit scalability and hinder evidence generation. In […]

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Reading Time: 4 minutes This blog was authored by Fiona Maini, global compliance and strategy principal, Medidata. Last month, the Medicines and Healthcare products Regulatory Agency (MHRA) unveiled its Delivery Plan for 2021-2023, which aims to drive forward a new era in clinical trial regulation. The plan outlines the MHRA’s core ambitions of putting patients first, becoming a […]

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Reading Time: 3 minutesSpecialty Therapy Drug Launches Require Special Attention Specialty therapies often come with a complex treatment regimen that requires a significant amount of data management expertise to maximize product and patient success. Managing data from sources like patient support services, medical claims, electronic medical records (EMR), de-identified protected health information (PHI), marketing, and real-world data (RWD) […]

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Reading Time: 3 minutesA Little SHYFT Analytics History SHYFT Analytics was founded in 2004 by a team of technology and life sciences experts, including Frank Lane—currently Medidata AI’s vice president of Customer Engagement for Commercial Data Solutions. Over the next 15 years, SHYFT provided commercial data management and insights for over 75 brands across the industry and dozens […]

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