Bringing the TMF In-House
with Ken Lownie and Janine Penman
Episode 1: Is It Time to Bring Your TMF In-House?
Episode 2: Laying the Foundation
Episode 3: Resource and Budget Constraints
Episode 4: Selling and Executing the Plan
Episode 5: Choosing the Right Technology
Episode 6: Integrating Clinical Sites
Episode 7: Operations and Inspection Readiness
Your Podcast Hosts
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.
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 @ firstname.lastname@example.org
Subscribe for Updates
Want to know when a new podcast episode is out? Subscribe here and we’ll send you a note.