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Reading Time: 2 minutes Good clinical practice recommendations prioritize patient safety and the generation of reliable and meaningful results from clinical trial operations. Trials built and conducted according to good clinical practice involve a risk-based, system-supported approach. Consequently, as sponsors and CROs continue to adopt new technologies to run trials, clinical operations increasingly integrate risk-based quality management into normal […]

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Reading Time: 3 minutes Despite years of effort to simplify and automate site budgeting and payments, financial management challenges are growing in life sciences. Since the early 2000s, 63% more sites participate in research, causing a sharp increase in the number of budget negotiations.[1] On average, over 10 weeks are spent negotiating every clinical trial budget and contract, causing […]

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Reading Time: 2 minutes As the demand for treatments, vaccines, and diagnostic tests remains high, companies depend on reliable and efficient study builds to initiate trials. According to Medidata’s published report, “COVID-19 and Clinical Trials: The Medidata Perspective,” for vaccines alone, there are 138 candidates in the preclinical phase, 35 in phase I or phase I/II trials, 4 in […]

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Reading Time: 3 minutesPatient centricity commonly surfaces as a buzzword in the life science industry—but what does it actually mean to run patient-centric trials? How do we truly engage patients to develop patient-centric solutions? How do we make sure patient centricity isn’t just a one-off exercise but a mutually beneficial ongoing partnership? At Medidata, Alicia Staley, senior director […]

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Reading Time: 3 minutes Last week the World Orphan Drug Congress virtually brought together industry leaders, patient advocates, and researchers to discuss topics related to rare disease, including advanced therapies, clinical development, manufacturing and commercialization of cell and gene therapies, and AI and digital solutions. Medidata’s Sheila Diamond, scientific business development, Acorn AI, and Alicia Staley, senior director, patient […]

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Reading Time: 2 minutes Even with the increased attention to clinical research in the news, public perception of participating in clinical trials is troubling. Each year the Center for Information and Study on Clinical Research Participation (CISCRP) surveys individuals on their perceptions of clinical trials. This year’s results show a significant decline in several key factors. The survey gathered […]

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Reading Time: 3 minutes Title of internship? Early Talent Summer Internship: Office of the CTO Location of internship? Remote Hometown? Brooklyn, NY What school did you attend? University of Buffalo What did you study? Psychology, BA How did you learn about Medidata’s internship program, and why did you join? I learned about Medidata through my technical Cloud Support Engineering […]

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Reading Time: 3 minutes Patient centricity in the life-sciences industry is growing as more companies include patients and patient groups in the clinical trial process and actively engage them throughout the drug development process. But in order to truly reap the benefits that patient-centric solutions have to offer, the key is to make sure that they aren’t just a […]

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Reading Time: 3 minutesHow Technology in Clinical Trials Benefits Both Sponsors and Patients The modernization of the clinical trial process is being driven in large part due to advances in technology. Tools such as electronic clinical outcome assessment (eCOA) and electronic patient reported outcome (ePRO) allow for both remote and real-time data capture. Wearable devices and even ingestible […]

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Reading Time: 3 minutes Clinical trials play a vital role in the development of new therapies for patients that need them. Traditionally, trial activities have been centered around trial sites, the locations where patients receive treatments and are evaluated to determine the safety and efficacy of the intervention. Traditional clinical trials require patient travel, which may be time-consuming, inconvenient, […]

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Reading Time: 2 minutes While clinical trials continue to incorporate imaging data to support efficacy and safety endpoints, many trials, especially phase I & II, still rely on investigator assessments to support these endpoints. For trials where investigator assessments support imaging endpoints, centralized collection of medical images is often an afterthought. However, imaging data can be the most expensive […]

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Reading Time: 3 minutes To create patient-centric clinical trials, sponsors need to cultivate mutually beneficial relationships with patients. Many patients believe pharmaceutical companies benefit the most from clinical trial data and outcomes. Sponsors can shift this paradigm by providing patients with both their individual data and overall trial data. Even giving trial participants a plain language summary of the […]

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