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.
Our PV operational and QA services and solutions ensure appropriate, actionable safety oversight of PV activities. We’re dedicated to open communication and collaboration required to build a cohesive team.
Founded and led by a quality assurance and compliance expert
Everything we do is rooted in dedication to customer focus, quality management, and the regulatory requirements designed to ensure data integrity and patient safety.
We apply a broad and deep understanding of the industry, its history, the current landscape, and our vision for a healthier future to proactively address your challenges in the following areas and more:
Optimized AI Query Crafting: Enhance the quality of your AI interactions with our expert assistance. We’ll guide you in framing ChatGPT and other AI questions to yield insightful, accurate, and high-quality results.
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Our Vision For You
Establish infrastructure that supports GVP compliance.
Build a fit-for-purpose PV quality system.
Build PV operational knowledge that enables appropriate oversight of PV vendors.
Build a seamless case processing flow that includes all stakeholders in your PV universe.
We offer a variety of PV training options, including company-wide PV and product complaint training, PV QA coaching and training, and more.
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What Clients Are Saying
Former European Area Qualified Person and Deputy QPPV, Johnson & Johnson
CEO, ARTMS Inc.
Former Senior Director, GPV Operations Management and North American Compliance & Business Management, Otsuka Pharmaceuticals
Penelope Przekop is a biopharmaceutical quality assurance and corporate compliance executive consultant with global R&D and commercial PV expertise. During the early 2000s, she developed and oversaw the first global PV quality and compliance departments established for Wyeth as well as Johson & Johnson. Her work includes qualification and oversight of numerous PV vendors covering all aspects of clinical safety and post-marketed PV. Penelope has facilitated numerous PV regulatory inspections. She frequently leads and conducts PV mock inspections and provides in-depth PV training.