Articles From Our Expert Network
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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.”
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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.
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“The 12 Months Of Quality:” Tips For Building A Voluntary QA Culture In 2019
12/26/2018
Rather than 12 days of gifts, here are 12 months of suggestions to assist you in helping your organization bring its quality efforts and programs to the next level. As you think about where you want to be in 2019, consider these thoughts as strategies for building more credibility, cachet, and value around quality.
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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.
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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.
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A Better Approach To Selecting And Overseeing GCP/GLP Vendors And Processes
10/18/2018
This is the third article in a series examining strategies that allow quality groups to collaborate with good clinical practice (GCP) and good manufacturing practice (GMP) divisions to improve compliance, increase clinical study robustness, and enhance data integrity.
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An Introduction To Financial Benchmarking In Biopharma Clinical Development
10/16/2018
The high cost and failure rate of new drug candidates going through clinical trials are well documented and a recurring subject of research both by industry and academia.1 Further, the cost of drug development is a debated topic, and there is no consensus on what the “true cost” is because of the different methods used for these calculations.2 The lack of adequate comparable cost data and value measures also makes it difficult for pharmaceutical sponsors and trial sites to implement financial benchmarking for planning, costing, and budget management.
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5 GCP Compliance Mistakes To Avoid With Job Descriptions, CVs, & Org Charts
9/11/2018
When it comes to GCP audits and inspections, low-hanging fruit says a lot about the tree.
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Precise Patient Recruitment Planning – It’s All About The Patient Pathway
8/28/2018
At this stage in my career, I confess that I’ve lost track of the number of publications and presentations I’ve developed and delivered on the topic of patient recruitment. Many of these have focused on lessons learned from troubleshooting hundreds of trials in “rescue mode.” As I reflect on why so many recruitment campaigns or efforts fail to deliver the expected results, a common root cause issue points to the lack of understanding of the importance of, and how to create, a meaningful patient pathway. This terminology may mean different things to different individuals and organizations and may be used interchangeably with patient journeys.
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4 Pitfalls To Avoid When Developing GCP SOPs
8/16/2018
This article is the second in a series examining strategies that allow quality groups to collaborate with GCP and GMP groups to improve ICH E6(R2) compliance, increase clinical study robustness, and enhance data integrity.