Gen Li

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Pharma and Biotech are Waiting for 21st Century Clinical Trial Data Analytics Engines

As a repository of clinical trial information, few databases are as trusted – or as widely used – as www.clinicaltrials.gov. A service of the U.S. National Library of Medicine, clinicaltrials.gov aims to provide comprehensive information on privately and publicly funded clinical studies conducted around the world. Many drug developers mine the database to facilitate decisions on trial design, investigator recruitment,…

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Predicting Investigator Site Enrollment Performance: Separating Myth from Truth

Throughout my two-decade career in the biopharmaceutical industry, my goal has been to make drug development more efficient while reducing costs, and to help the companies I have worked for increase revenue without compromising quality. In pursuing that goal, I have strived to embrace advanced technologies and to optimize organizational and operational structures. Now that I have joined Phesi, I…

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Site, Investigator, or Investigator Site?

The life sciences industry is riddled with casually used terms, acronyms and phrases which are often used out of context or defined differently among companies or individuals. This becomes especially problematic when developing and designing clinical trials, as terms that are tossed around as ‘givens’ can be much more complex processes that may dictate success or failure of a clinical…

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Phesi Investigator Site Selection: an AI propelled platform

Much has been discussed about artificial intelligence in our industry. Coming to the core issues in clinical trial planning and execution, such as protocol design optimization, investigator site selection and the business process to put select investigator sites to work [namely site activation], we have yet to see hardly anything in the public space. In fact, our industry has been…

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Using Actions, Not Words, to Reimagine Medicine

2018 has been a banner year for big pharma companies to re-focus on scientific innovation, with several companies making major investments in technology to advance the promise of personalized medicine. Take for example Roche’s acquisition (in February) of Flatiron Health – which provides almost real-time oncology patient data drawn from a network of cancer centers – for a whopping $1.9…

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Site Effectiveness Index: A strategically important metric in clinical trial planning

The importance of site activation planning and implementation is a given among those who develop and manage clinical trials. However, some key considerations are often overlooked in the planning process, such as: How should we measure site activation? What is a good site activation plan? How do we define the relationship between site activation and other variables in clinical trial…

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Phase 2 Trials Often Halted Due to Enrollment Problems

Oncology trials are most susceptible – see lung cancer analysis as a prime example Take us up on our challenge to rank the top 5 companies with the highest rate of Phase 2 trial terminations, and get a free Phase 2 trial audit report When we talk about failure in clinical trials, many people automatically focus on Phase 3, so…

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Using Data Analytics to Evaluate Clinical Trial Network Performance: A Look “Under the Hood”

As the clinical research environment becomes more complex and competitive, pharmaceutical companies are increasingly relying on networks of physicians to conduct their critical trials. The appeal of these networks is understandable: rather than evaluate and assemble a team of individual investigators one-by-one, engaging an existing network of investigators can, theoretically, expedite the processes of protocol design and patient recruitment, thereby…

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Staying Relevant With Smart Indication And Incisive Trial Planning

It may seem obvious that #clinicaltrial planning needs to be well informed. However, in our experience at Phesi, many trial sponsors don’t do complete due diligence to optimize success. Even when they have successful outcomes, many trials take too long and cost too much. That is never an ideal scenario, but sometimes is less risky, such as when a company…