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Reading Time: 2 minutesIn the fast-paced world of clinical trials, managing patient randomization, drug supply, and site logistics can be a complex challenge. That’s where interactive response technology (IRT) comes in. IRT plays a critical role in ensuring that clinical trials run smoothly and comply with regulatory requirements. But what is IRT, and how does it fit into […]

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Reading Time: 2 minutesEnsuring data integrity in clinical research is essential for regulatory compliance and producing valid study results. Protocol deviation remains one of the most significant challenges, potentially undermining study credibility, impacting patient safety, and delaying regulatory approval. While clinical data management is not directly responsible for protocol deviations, it plays a crucial supporting role in identifying, […]

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Reading Time: 3 minutesClinical research is taking another major leap forward. For decades, drug development relied on in-person, site-based clinical trials as the gold standard for gathering safety and efficacy data. Today, as our global clinical trial ecosystem evolves—shaped by digital health technologies, patient centricity, and the urgency accentuated by the COVID-19 pandemic—this traditional model has shifted. Decentralized […]

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Reading Time: 3 minutesEffectively and accurately measuring disease progression in central nervous system (CNS) diseases, such as multiple sclerosis (MS), is complex and challenging. MS generally presents with a wide range of motor, cognitive, sensory, and visual impairments which can vary greatly between individuals over time. Adding to the difficulty are traditional clinical assessments that often rely on […]

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Reading Time: 4 minutesClinical trials are the building blocks of modern healthcare. The eczema ointment within reach in your bathroom cabinet, the antiretrovirals that allow people with HIV to live long and healthy lives, and the various treatments giving hope to patients across the globe—these are all the result of careful testing to make sure they’re safe and […]

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Reading Time: 5 minutesThe International Council for Harmonisation (ICH) is standardizing drug and medicine development for greater safety and efficacy. Good Clinical Practice (GCP) guidelines for the industry date back to the 1990s, and there was an update to these in 2016. But this third revision (R3) is a real modernization of the guidelines as we know them […]

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Reading Time: 3 minutesManaging essential trial documentation efficiently and compliantly is paramount in the fast-evolving world of clinical research. The electronic trial master file (eTMF) has emerged as a transformative solution, revolutionizing how clinical trial records are stored, managed, and accessed. Unlike traditional paper-based trial master files—which require manual effort and physical storage—the eTMF digitizes the entire process […]

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Reading Time: 6 minutes“Alzheimer’s is the cleverest thief, because she not only steals from you, but she steals the very thing you need to remember what’s been stolen.” – Jarod Kintz1 For patients living with neurological or neurodegenerative disorders, memory loss is a devastating erosion of identity. Diseases that affect the central nervous system (CNS), like Alzheimer’s, chip […]

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Reading Time: 5 minutesIn episode 1 of from Dreamers to Disruptors, Jessica Federer joins to explore the rise of digital therapeutics and the fight against women’s healthcare inequality.

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Reading Time: 5 minutesThe adoption of RBQM in clinical trials has surged in recent years. According to a 2023 survey by the Tufts Center for the Study of Drug Development, sponsor and CRO companies are incorporating RBQM components in over half (57%) of their clinical trials. The most frequently cited challenges to RBQM implementation were a lack of […]

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Reading Time: 8 minutesSuccessful clinical trials rely on the collection and analysis of data from a wide variety of sources, including sites, patients, and labs, and linking clinical data to real-world data. Data collection typically comes from different systems and multiple vendors. Review and analysis are carried out by multiple stakeholders (data managers, CRAs, central monitors, medical monitors) […]

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Reading Time: 5 minutesArtificial intelligence is reshaping the design, planning, and execution of clinical trials. New efficiencies, capabilities. and opportunities are emerging everywhere: from early study design to data collection, trial operations, and beyond. As complexity increases and resources tighten, AI offers a new path forward—one that’s faster, more adaptive, and better-informed. Significant benefits for patients are expected […]

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