Articles From Our Expert Network
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Clinical Study Conduct During The COVID-19 Pandemic — Challenges & Solutions
4/6/2020
Life science companies across the world are scrambling to mitigate the impacts of COVID-19 on their clinical studies and business operations, and there are no clear-cut answers at this time, nor a one-size-fits-all solution. But what we do know is that we are all in this together and that this is another challenge that the biotech industry was built for.
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Assessing The Impact Of COVID-19 On Regulatory Interactions, Inspections, & Audits
3/19/2020
While we have not seen any significant delays in regulatory approval of life science products to date, the impact of COVID-19 on regulatory interactions, inspections, audits, and global health authorities is continuing to evolve.
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The 5 Pillars Of Clinical Trial Material Management
2/25/2020
Ensuring that enough study drug supplies are available at study sites is a requirement of every clinical trial. This article discusses five fundamental tools and techniques for effective planning, execution, monitoring, and inventory control of clinical trial material from the manufacturing, packaging, and distribution perspectives.
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Free-From-Harm Training: Protecting Patients & Creating Competencies In Clinical Trials
2/20/2020
The basics of medical practice are to do no harm, and the core tenets of GCPs are to protect the rights, safety, and well-being of the trial subjects. When training doesn’t allow for practicing clinical research competencies in a safe environment, then we are in danger of violating the principles we are trying to teach.
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Clinical Trial Root Cause Analysis: Can’t We Do Better Than Five Whys?
1/15/2020
Root cause analysis should be a chance to take a step back and try to understand why an issue occurred, and to think critically, understand the process, and determine how the issue came about. The Five Whys approach can lead us to a simple “root cause” and action, but does it enable us to really understand the issue?
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Analyzing The Top Clinical Trial Technology Trends
11/29/2019
Technology plays a critical role in drug development and the R&D value chain by revolutionizing clinical trials and decreasing the failure rate. Though the supply of technology has been increasing and regulation of innovative methods is easing, pharmaceutical companies have been slow to use the emerging technologies, due to the ambiguity prevailing around this space and a highly fragmented supply market. This article outlines the key technologies that have a high impact across trial phases.
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The Myth Of Disruptive Innovation In Clinical Trials: Time For A More Disciplined Approach
11/21/2019
At the outset, let me state for the record that I’m a big advocate for change. My threshold for accepting “that’s the way we’ve always done things” is actually quite low. But I confess that I’m getting a bit dizzy, dismayed, and, to be frank, disappointed with all the so-called “disruptive innovation” taking place in the industry. First and foremost, I don't really think that anything taking place really qualifies as disruptive.
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SOP Remediation: When Reinventing The Wheel Is The Best Approach
11/12/2019
When faced with scenarios that demand SOP remediation (outsourcing, mergers, acquisition), repurposing processes, written content, templates, etc., can be the worst possible and most expensive approach when you factor in time, human resources, and long-term outcomes.
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3 Surefire Approaches To SOP Harmonization
7/25/2019
We seem to be buried in standard operating procedures (SOPs). So how the heck are companies supposed to make the SOP mountain smaller through harmonization?
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Teaching Old Dogs New Tricks: Can Competency With Clinical Research Technologies Be Enhanced?
4/30/2019
Many workplaces are composed of five generations, from traditionalists to Generation Zs. While this can lead to a host of communication, productivity, and other issues, the challenges are perhaps never more apparent than with the introduction and use of new technologies. In fact, this has led some to claim age isn’t the deciding factor when it comes to describing how proficient people are with digital technologies and culture.