Articles From Our Expert Network

51. 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.

52. 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.

53. 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.

54. 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.

55. 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.

56. A Simulation-Based Approach To CRO Selection 6/21/2018

    Protocol or clinical trial simulations have been on the radar screen of the industry for quite some time as a technique for optimizing trial design and decision making.

57. Employing GMP Techniques In GCP For More Robust, Compliant Clinical Studies 6/12/2018

    Most of my career has been on the good manufacturing practices (GMP) side of industry, where, despite moments of ambiguity or confusion, everything is presented in black-and-white terms. And over the last five years or so, I have had the pleasure of supporting and/or overseeing the good clinical practice (GCP) side of industry, experiencing the more “human” side of the business.

58. Training As A Site Engagement Strategy 4/26/2018

    Raise your hand if you are a sponsor/CRO that wants to be the organization of choice for investigative sites. Now, raise your hand if you put your sites through endless hours of Web or e-learning training as part of the study start-up process. This is just one of several surefire ways to kill a site’s enthusiasm and commitment to working with you or on your studies. Another, for the record, is sending ill-prepared clinical research associates (CRAs) who are not training specialists to do the PowerPoint death march at site initiation visits (SIVs)!

59. An Analysis Of Clinical Development Benchmarking Practices 4/3/2018

    Pharma companies use performance and competitive benchmarking to identify opportunities during their drug development cycle. The benchmarks are aimed at finding ways to make improvements in cost savings, lead time reduction (faster drug to market), and quality of services.

60. Revamping The Vendor Qualification Process For Clinical Stage Outsourcing 3/29/2018

    Consumer awareness of the quality of goods purchased is good practice in any industry, but in biotech and pharma, it is a regulatory requirement. One of the most common goods we purchase in this industry is a vendor’s services — their time, effort, and resources. Whether it be a lab, CRO, or data management group, the FDA mandates we, as sponsor companies, know the quality of the goods and services we purchase from them.