Podcast Series

Bringing the TMF In-House

with Ken Lownie and Janine Penman


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 7 episode series takes 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.

Podcast Bringing TMF In-house

A 7-Episode Series on Bringing the TMF In-House

Episode 1: Is It Time to Bring the TMF In-House?

Episode 2: Laying the Foundation

Episode 3: Staffing and Budgeting Considerations

Episode 4: Selling and Execution the Plan

Episode 5: Choosing the Right Technology

Episode 6: Integrating Clinical Sites into the Process

Episode 7: TMF Operations and Inspection Readiness


You can also find all episodes on Sounder.fm, Apple Podcasts, and Spotify.

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Ken Lownie

Ken Lownie – Head of North American 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. 

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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).


Calling All Potential Guests

Interested in joining us on the podcast for an episode or two?

Drop us an email and we’ll chat.

Email Barb @ us_info@agathalife.com

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