ARTICLES BY PENELOPE PRZEKOP

• The FDA Speaks Up For Quality Management: Must They Beg?

  2/20/2024

  The FDA's quality by design (QbD) and risk-based monitoring (RBM) messaging began more than 10 years ago with their guidance on RBM. Eleven years, five total related key guidance documents (listed below), and one global pandemic later, why aren’t we moving forward at more than a snail’s pace? 

• 3 Reasons Why Sponsors Must Review Monitoring Reports

  12/5/2023

  Despite recent progress in executing and documenting oversight, sponsor oversight remains a challenge, especially with monitoring reports. Penelope Przekop detail three reasons why they must remain top of mind.

• Why Sponsor Awareness Cannot Be "Day Zero" For SUSAR Reporting

  8/16/2023

  Part 1 of this article explained that the FDA’s goal is to ensure safety not to provide a compliance safety net to sponsors by enabling arbitrary rules around SUSAR reporting timelines. A few readers raised points to justify using sponsor awareness as Day Zero for SUSAR reporting, regardless of when the PI becomes aware. Part 2 addresses those points and why they miss the mark.

• Why Clinical Site Awareness Should Be "Day Zero" For SUSAR Reporting

  5/3/2023

  Ask a handful of clinical research professional about the determination of "Day Zero" when reporting a suspected, unexpected, serious adverse reaction (SUSAR), and you may get a variety of answers. While sponsors are ultimately responsible for SUSAR reporting adherence, Penelope Przekop contends that clinical sites should be the ones that start the clock when it comes to meeting regulatory timelines.

• 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.