Clinical Solutions

Maintain direct oversight and control over clinical development and operations with innovative, practical solutions and collaboration.

Our Services

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:

Market Research & Product Development Planning
Clinical Process & SOP Development
Project Management
Vendor Selection & Operational Vendor Oversight
Clinical Data Management
Medical Writing
Contract & Budget Management

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.
  • Establish internal expertise aligned with regulatory expectations for operational oversight.
  • Create and document internal processes that clarify internal roles and responsibilities and the outsourcing model.
Build a fit-for-purpose clinical quality system.
  • Establish practical processes and documentation that evolve with the clinical development program.
  • Institute internal processes that optimize resources and demonstrate oversight.
Build clinical expertise that enables appropriate oversight of clinical vendors.
  • Continuously improve pharma industry knowledge and subject matter expertise.
  • Develop useful and efficient documentation of oversight that can be provided during regulatory inspection.
Build a roster of clinical vendors that will live up to their promises and produce high quality deliverables.
  • Leverage our expertise to optimize vendor selection.
  • Establish clear contractual and quality agreements.

Training Solutions

We offer a variety of clinical research-related training options.

View our Services Menu for a detailed list of topics and options.

What Clients Are Saying

"PDC took on a delicate and challenging task in helping maintain contact with a geographically and therapeutically diverse group of investigators (some of whom were struggling with the demands of the trial program in question) and customers.

Their conduct, versatility and effectiveness in this challenge was excellent, and they became a much-valued part of the global team."

Mark Watling

Former Group Medical Director, Archimedes

"PDC’s knowledge of process excellence and regulatory guidelines is beyond impressive and has been invaluable to my team and clients.

Any company would be lucky to have the opportunity to work with PDC."

Liimu McGill

CEO, LSM Consulting

"Dedicated and experienced, PDC contributed immensely to the advancement of the organization."

John Harkins

Former Senior Director, GPV Operations Management and North American Compliance & Business Management,Otsuka Pharmaceuticals

Our Leadership

Janet Flisak, MBA, BSN
Head of Clinical

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.

How can we help you?

Reach out to schedule a consultation.