Clinical Guest Contributors
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Increasing Diversity In Clinical Trials: The Critical Role Of Community Partnerships & Collaborations
10/6/2020
Meaningful long-term engagement, collaborations, and partnerships — rather than those based on specific trial or project needs — deepen community relationships, build trust, gain an understanding of community priorities, and make research programs more responsive to the needs, values, and perspectives of the affected populations.
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Capacity & Competency Of The Clinical Research Workforce — Today & Tomorrow
9/29/2020
It’s not simply an issue of supply and demand. It’s closer to life and death. Put bluntly, we may not be able to keep up with future clinical trial demand because our workforce isn’t growing fast enough. In fact, by some metrics, we’re already falling behind.
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COVID-19’s Impact On The Clinical Trial Ancillary Supplies Industry
9/24/2020
With restrictions on logistics, and countries implementing new restrictions to address increasing COVID-19 cases, it’s important to understand how to manage clinical trials’ ancillary supplies — like sourcing from the right suppliers, managing distribution to all trial sites, stock management, and response to new regulations.
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Safeguarding Participant Data During Risk-based Monitoring — Practical Considerations
9/22/2020
With risk-based monitoring becoming more common, and with sponsor/CRO monitors reviewing electronic source data remotely, many questions have arisen regarding what security measures need to be in place to ensure the protection of study participants’ data.
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Can Virtual Trials Maintain Their Momentum After COVID?
9/17/2020
Prior to COVID-19, there were many discussions about how it might be possible to conduct virtual trials, using technology and innovative measures. Now that the pandemic has forced many trials into virtual settings, what will it take for the industry to fully implement a virtual approach beyond the pandemic?
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9 Factors For Driving Inclusivity & Patient Centricity In A Transformed Clinical Trials Landscape
9/15/2020
Patient-centricity, quality, and inclusion are not natural consequences of the shift to virtual clinical trials. To be intentional with the design, we must start with articulating and understanding the full contexts of patients’ lives, medical and beyond.
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What Is Your AI Road Map To Revolutionize Drug Development?
9/8/2020
When it comes to artificial intelligence (AI), many organizations do not know where to start or waste their energy going in many directions without a clear vision. This article will share insights on how to pragmatically initiate an AI journey using the evolution of clinical data management as an example.
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How FDA Is Helping Advance Clinical Trial Diversity
9/1/2020
An update from the FDA Office of Minority Health and Health Equity on its efforts to address health disparities and health equity — and ultimately strengthen the agency’s ability to respond to minority health concerns.
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How Storyboarding Can Bring Clarity To Regulatory Inspection Readiness & Facilitation
8/25/2020
Developing storyboards for regulatory inspection readiness and facilitation is a growing trend, yet the tool is shrouded in mystery for many pharma industry professionals. (Downloadable storyboard template included.)
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Discovering & Motivating Talent In The Life Sciences: Redefining “Other Duties & Responsibilities”
8/21/2020
How do we attract the right kind of talent to a role within our organizations? How do we take the same innovative approaches in our talent acquisition processes that we put into our products? One answer can be found in an often-overlooked bullet point in a common job description: “other duties and responsibilities as required.”