ARTICLES BY PENELOPE PRZEKOP

• 6 Novel Mock BIMO Regulatory Inspection Exercises

  2/22/2023

  Don't get caught on your heels. Conducting a mock regulatory inspection in preparation for an FDA, EMA, or other regulatory visit is a key industry inspection readiness activity. Explore six new inspection exercises to help your team prepare for the big day(s).

• A 3-Point Strategy For Training Part-Time GCP Consultants

  11/17/2022

  Global biopharma regulations and guidelines require that individuals involved in conducting clinical trials be qualified by a combination of education, training, and experience. The components are straightforward to implement regarding internal employees, but not so clear when it comes to part-time consultants contracted to intermittently execute specific good clinical practice (GCP) tasks. Discover three trips for training independent consultants.

• 3 Strategies To Lead Clinical Research With Moral Integrity

  9/1/2022

  In clinical research, perhaps our oldest code we live by is the Hippocratic oath. Our industry is more complicated today than ever before, so how can we remain loyal to our shared code while also supporting the innovative solutions and approaches of the modern world?

• 3 Best Practices For Actionable CRO Oversight

  4/7/2022

  The ultimate purpose of sponsor oversight is to act when required. Audits, meetings, and documentation are not always enough. Too many sponsors seem to be forgetting that they are the customer; one that’s paying a heavy price for services that can ultimately make or break them. Reset the industry balance with these 3 best practices.

• Your New 6-Step Approach For CRO Selection In 2022

  2/15/2022

  Unfortunately, whether you’ve chosen the right clinical research organization (CRO) isn’t always obvious until contracts are signed and patients are enrolled. In 2022, basic industry standard steps are being skipped left and right. Here are 6 win-win suggestions to incorporate into your vendor selection strategy.

• 4 Imperatives For Updating Our Clinical Quality Systems Approach For 2022 Pharma

  7/29/2021

  The clinical quality management systems approach developed 20 years ago is not sustainable in the today’s industry because we've seen dramatic industry changes in outsourcing, remote monitoring, the use of electronic systems in clinical research, and more. But how do we update our approach for 2022 pharma? This article examines 4 imperatives, including how to accomplish them.

• How To Improve FDA Inspection Readiness & Outcomes By Mining Publicly Available Data

  10/14/2020

  Now that we have years of real-world regulatory outcomes data available, why are we ignoring their power to serve as a corrective lens for our interpretations of the law?

• 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.)

• 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.

• 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?