Featured Clinical Leader Editorial
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How BMS Uses AI To Improve Study Design And Reduce Costs
1/19/2023
In 2022, Bristol Myers Squibb (BMS) announced plans to work with AI developer Owkin to design and optimize cardiovascular drug trials. The partnership will allow BMS to use machine learning to enhance clinical trial design and execution.
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Embracing Agility In Phase 2 Clinical Trials
1/19/2023
Phase 2 clinical trials are like software development. How so? Ivanna Rosendal explains the connection and makes the case for using a now-ubiquitous software development workflow to improve clinical data management.
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FDA Releases Final Guidance On Early-Phase Cell & Gene Therapy Trials
1/18/2023
The cell and gene therapy development process involves screening different variants of a product type. To aid this process and to ensure that suitable evidence is gathered so that effective variants of the product are taken through to later-stage trials, the FDA has produced a final guidance, Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early-Phase Clinical Trial.
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The Long-Term Impact Of COVID-19 On Clinical Trials: Part 2
1/16/2023
The COVID-19 pandemic is helping create a “new normal” for the life sciences industry regarding the policies, procedures, and processes of clinical trials. In Part 1, we discussed five factors that more directly impact the clinical trial process and patients. In Part 2, we will discuss six factors that focus on organizational structure and the broader industry.
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The Long-Term Impact Of COVID-19 On Clinical Trials: Part 1
1/11/2023
Pandemics provide a massive pressure-test of healthcare systems, allowing us to isolate what works well and what merits improvement. The COVID-19 pandemic is going to create a “new normal” regarding resetting the equilibrium in a variety of policies, procedures, and processes. In Part 1, we examine five factors that more directly impact the clinical trial process and patients.
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The 4-Step Checklist For Small Biopharmas To Recruit & Retain Clinical Trial Managers
1/10/2023
Talent shortage is causing a backlog in clinical studies. One position critical to helping ease this jam is clinical trial managers, who serve as the primary organizer and supervisor over the trial. If you work at a small bio/pharma company, this article is for you.
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The Future Of TransCelerate: Clinical Trial Modernization
12/19/2022
In January 2023, Janice Chang will take over as the head of industry consortia non-profit organization TransCelerate. Chang has been involved with TransCelerate since it was just a concept, and notes the time spent in the group since its launch has been an amazing journey.
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A Firsthand Experience In Africa — Sub-Sahara Has A Lot To Offer
12/6/2022
In “Better Than Expected — A Firsthand Experience In Africa,” Kamila Novak shared her positive impressions from visiting medical research centers in sub-Saharan Africa. However, the picture would not be complete without talking about the continent’s personal safety and professional security, regulatory landscape, and ongoing socioeconomic challenges.
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4 Strategies For Recruiting & Retaining A Diverse, Well-Trained Workforce
12/2/2022
The projected growth of the clinical research industry demands that the workforce keep pace with the workload — and it must be diverse and research-ready. What’s at stake? Nothing more than the risk of delaying approvals of new treatments for patients who need them.
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A Firsthand Experience In Africa — Better Than Expected
11/29/2022
Except for South Africa, sub-Saharan African countries are still largely underrepresented in the global clinical study map. Hesitation to conduct clinical studies in Africa may be partly a result of assumed poor infrastructure, missing regulations, and inexperienced researchers. But is it truly so? Or is our thinking stuck somewhere in the past?