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.” I dedicated bits and pieces of my free time over the next five years to writing my first novel. During that time, I wasn’t focused on how improving my writing skills might impact my pharma industry career, which was well underway. Now, I know firsthand that all those high school and college English, writing, and literature teachers and professors were right when they told us that excellent writing skills can take us far in any career.
Our services and solutions ensure appropriate, actionable sponsor oversight of GCP activities across therapeutic areas. We’re dedicated to the 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 high integrity data 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.
Visit our Pharmacovigilance Page to explore our clinical drug safety solutions.
View our Services Menu for a detailed list of our solutions.
Our Vision For You
Build clinical development and operations infrastructure that supports compliance.
Build a fit-for-purpose clinical quality system.
Build clinical expertise that enables appropriate oversight of clinical vendors.
Build a roster of clinical vendors that will live up to their promises and produce high quality deliverables.
What Clients Are Saying
Their conduct, versatility and effectiveness in this challenge was excellent, and they became a much-valued part of the global team."
Former Group Medical Director, Archimedes
Any company would be lucky to have the opportunity to work with PDC."
CEO, LSM Consulting
Former Senior Director, GPV Operations Management and North American Compliance & Business Management,Otsuka Pharmaceuticals
Janet Flisak is a strategic, results driven clinical research professional with over 25 years of industry experience.
She began her career in critical care nursing, then entered the industry as a medical writer with advancing roles in clinical operations and clinical development. To date, Janet has served as a global team leader with oversight of trial managers in conducting international studies, with primary focus on Phase 3. Her broad understanding of local and global regulations has contributed to her strong record of overseeing the compliance of numerous complex studies.
In addition to authoring numerous protocols and clinical study reports, Janet has contributed to several NDAs and BLAs. Her expertise encompasses multiple therapeutic areas, including oncology, hematology, immunology, endocrinology, rheumatology, psychiatry, sexual dysfunction, rare disease, NASH, COVID-19, and immuno-oncology. She has both large and small molecule experience spanning Phase 1 (including first-in-human) through Phase 4.
Janet is a registered nurse who holds an MBA from University of Phoenix; a BS in Business Administration and Marketing from University of Pennsylvania, Wharton School of Business; and a BS in Nursing from Reading Hospital School of Nursing, Albright College.