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Reading Time: 3 minutes In our previous posts, we talked about the role of a unified platform in providing better patient outcomes and the benefits to an investigator site. This type of software allows your organization to access all of its data in one place. Your users can also quickly sort through their data, identify patterns, and flag areas […]

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Reading Time: 3 minutesThis post is guest-authored by Sharon W. Ayd, founder and CEO of Ayd Biopharma Consulting Group. Sharon is is a senior, international operations executive with experience in creating and operationally implementing corporate strategy for highly competitive multi-national Biopharmaceutical companies. She has previously held executive positions with Fresenius-Kabi, Hospira and Pinnacle Biologics. For many companies, selecting […]

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Reading Time: 2 minutes Our Medidatians are all unique and amazing in their own ways. In our Meet a Medidatian series, we introduce you to Medidata employees from all over the world and share some interesting, fun, and surprising facts about what makes them who they are. Meet Gowri, who leads Acorn AI Labs in NYC, where our data […]

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Reading Time: < 1 minutes Medidata (a Dassault Systèmes company) is happy to announce that Senior Director of Patient Engagement Alicia Staley won the 2019 eyeforpharma Patient Advocate of the Year Award! This prestigious honor recognizes a person or group who has given other patients a stronger voice, through advocacy work, that has created new communities, raised awareness or empowered […]

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Reading Time: 2 minutes When it comes to clinical trials, an already rigorous oversight environment has become even more so. With an increasing number of data sources, complexity of protocols and disparate systems, clinical trial teams are finding it nearly impossible to manage it all. Couple this with the growing need for more sites and countries to power a […]

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Reading Time: 2 minutes Previously, we shared survey results revealing clinical trial conduct changes and the impact these changes are having on the workload of ClinOps personnel. Today, we’ll look more closely at how these changes are affecting their ability to complete their work. To recap our first blog, 90% of respondents said their workload increased as a result of […]

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Reading Time: 2 minutes In our second blog, we shared survey results that indicated only 2% of ClinOps teams were able to complete all of their tasks on time. Today, we’ll look at how the respondents identified operational issues and initiated change. Because they are bogged down and overwhelmed with tasks, many ClinOps teams lack enough time to get work […]

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Reading Time: 3 minutesA randomization and trial supply management technology system, or RTSM, is a valuable asset in the clinical study management armamentarium. An RTSM solution can efficiently and accurately control patient randomization, automate supply and resupply to sites, and most importantly, handle dispensation of a drug to trial subjects. In some cases, it can be set up […]

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Reading Time: 2 minutes In our last blog, we discussed survey results showing the vast majority of ClinOps teams in clinical trials aren’t able to identify issues and take action quickly, a result of being overwhelmed with more work. Today, we’ll look at organizations’ ability to use trial data for strategic decision-making as well as their effectiveness in collaborating […]

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Reading Time: 4 minutesThere are about 7,000 rare diseases affecting over 400 million people worldwide with more discovered every year. Yet, only 500 therapies have been approved.1 Since the 1993 Orphan Drug Act, the number of rare disease designations has skyrocketed. With global sales forecasted to reach $262 billion by 20242, the orphan drug market is growing at […]

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Reading Time: 11 minutesNote: This post has been updated on October 20, 2020 to incorporate updated guidance provided by FDA in v9 of their COVID-19 Guidance. This post is guest-authored by Ari Feldman, Vice President, Global Compliance & Strategy, Philip Coran, Principal, Global Compliance & Strategy, and Fiona Maini, Principal, Global Compliance & Strategy, Medidata. In light of the […]

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Reading Time: 3 minutesThis post is guest-authored by Andrea Falkoff, Director, Clinical Imaging Delivery, Medidata. Oncology assessments performed via medical imaging in a clinical trial are often performed by a local radiologist at the trial site and via blinded, independent central reviews (BICRs) performed by radiologists who have been contracted through an imaging core lab. In fact, the FDA […]

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