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On the Frontlines of Clinical Operations

Join us as we chat with leading practitioners in the clinical operations space. You’ll get first-hand information, expertise, how-to’s and more from those that are working in this industry every day.

Agatha Podcast Series

Featured: Is It Time to Bring Your TMF In-house?

Podcast Bringing TMF In-house

If you are struggling with applying the proper management and oversight needed to ensure your clinical trial processes and documentation are accurate, maybe it’s time to bring the management of the trial master file (TMF) in-house. 

This podcast series will take you through all the things you need to think about and plan for, from budget to resources, to technology, and inspection readiness, we cover it all. 


Meet The Hosts

Ken Lownie

Ken Lownie

Head of NA Operations, Agatha

Ken has over 20 years of experience working with technology companies building solutions that support the demands of enterprise companies. Today, he works with life sciences companies to implement technology solutions that automate and accelerate clinical operations processes. He is a frequent writer and speaker on technology adoption in life sciences. 

Janine Penman

Janine Penman

Founder and CEO of JPScientific, Inc

Janine is a pioneer thinker in the world of eClinical Systems and the Clinical Systems Integration Movement, a paradigm shift in thinking dedicated to connecting currently disparate eClinical Systems to facilitate a truly unified Trial Master File (TMF). She is a subject matter expert in eClinical Systems remediation, clinical strategy, and quality management. She has over 23 years of experience leading culturally diverse global teams across 30+ markets, including South America, the Middle East, Asia Pacific, India, Eastern and Western Europe, and Russia. She is globally recognized as an experienced leader in Clinical Quality Compliance.

She is currently the Founder and CEO of JPScientific, Inc., a Clinical Operations and Process & Quality Management consulting firm headquartered in Pennsylvania, US. She leads teams in delivering best-in-class strategy consulting and process improvement in Clinical Operations and Quality Compliance. She also has experience designing and implementing comprehensive Quality Oversight Programs that incorporate the newest approaches to Risk-Based Quality Management (RBQM).

Janine’s passion for technology and quality has made her a lucrative executive consultant for companies of multiple sizes and stages. She is poised to disrupt the TMF world with her strategic and novel strategies to help companies bring their TMF in-house and save time and money with her forward-thinking approach.

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