Articles From Our Expert Network

41. 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.

42. 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.

     

43. 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.

44. 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.

45. 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?

46. 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.

47. 3 Powerful Writing Tips that Will Significantly Improve Your Clinical SOPs 4/18/2019

    In addition to my career as a pharma industry consultant, I’m a writer. While I don’t claim to be the next Ernest Hemingway, I do consider myself a decent writer. I’ve put in the 10,000 hours of writing Malcolm Gladwell told us it takes to be an expert in his 2008 book, Outliers: The Story of Success . I’ve always had a passion for writing. At 24, I made a serious commitment to become a real “writer.”

48. Top 5 Strategies To Execute And Document GCP/GVP Vendor Oversight 2/7/2019

    Over the last 10 years, the face of clinical research & development (R&D) and pharmacovigilance (PV) outsourcing has dramatically changed. What was a common industry scenario by 2010 — a full-scale operational pharma company utilizing both international and U.S.-based contract research organizations (CROs) to execute clinical investigator site monitoring and data management — has evolved into a new common scenario in 2019.

49. Talent Wars: How To Develop A Competent Clinical Research Workforce In A Competitive Environment 12/18/2018

    A booming economy brings opportunities, and the biotech industry is booming. But with that comes challenges, particularly with regard to finding qualified candidates to fill the growing number of jobs.

50. From Cowardly Lions To Courageous Decision Makers: What ClinOps Needs Now 10/25/2018

    Fall is in the air, and Halloween is just around the corner. I always associate Halloween with “The Wizard of Oz.” When I grew up, Halloween meant reruns of the movie and was a highly anticipated annual family viewing event. Dorothy, the Wicked Witch of the West, those creepy flying monkeys, and, of course, the Wizard. We all had our favorite characters, and my poor parents had to contend with my post-movie nightmares for days. But it’s the Cowardly Lion who's been on my mind recently.