All Episodes
Matt Jones
Chair of the RQA Board and Founder/CEO, Digital Quality Associates
Tom and Matt discuss the shift to risk-based validation, the growing role of AI in pharma, red flags auditors should watch for, and effective IT vendor management.
Ricky Lakhani
Chief Product Officer, PHARMASEAL
Tom and Ricky discuss the cost of disconnected systems in clinical trials, quality by design principles, and the Mayet-PHARMASEAL integration partnership.
Kalyan Obalampalli
Founder and President, Clin.AI
Tom and Kalyan discuss vendor selection challenges, the financial consequences of poor vendor choices, and practical tips for smaller biotech companies.
Barry McManus
Principal Consultant, Empowerment Quality Engineering
Tom and Barry discuss managing technology vendors, the critical role of risk assessment in validation, and myth-busting common misconceptions about compliance.
Matthew & Stephen, part 2
Founders, BlueGreen Clinical
Part two continues with vendor off-boarding, closeout best practices, proactive risk management, and the role of technology in strengthening CRO relationships.
Matthew Hersch & Stephen Crow
Founders, BlueGreen Clinical
Tom, Matthew, and Stephen discuss governance in clinical trials, the vendor management lifecycle from selection to onboarding, and building trust with CRO partners.
Tom Lazenby
Founder & CEO, Mayet
In this special episode, Kalyan interviews Tom about the journey of building Mayet, the importance of integrity in business, and the future of vendor management software.
Carl Ellis
Managing Partner, Simflex Consultancy
Tom and Carl discuss the intricacies of procurement in clinical trials, including stakeholder relationships, balancing cost and quality, and practical tips for transparency.
Henrieke de Bie
Founder, Beyond Compliance
Tom and Henrieke explore the intersection of behavioural science and quality management, including psychological safety, accountability, and building quality culture across organisations.
Keith Berelowitz
Founder, PatientRx
Tom and Keith explore how patient engagement reshapes service provider selection, the role of patient feedback in trial delivery, and the future of patient-centric approaches.
Christoph Ortland
Founder and CEO, FD CRO
Tom and Christoph discuss the unique challenges small sponsors face with regulatory compliance, risk management, and the growing importance of digital tools.
Yvanne Enever
Founder and CEO, PHARMExcel
Tom and Yvanne discuss building quality partnerships between sponsors and CROs, balancing academic and commercial needs, and preparing for GCP Revision 3.
Virginie Barthel
Clinical Operations Consultant
Tom and Virginie explore how digitalisation and software adoption can simplify clinical operations, improve trial timelines, and reduce manual tasks.
Jo Burmester
GCP Trainer & Consultant
Tom and Jo discuss best practices for vendor selection, ensuring GCP compliance, and strategies for managing vendor risk while avoiding common pitfalls.
Smaranda Doucet
Founder & CEO, Flow Trial
Tom and Smaranda explore actionable tactics for effective sponsor oversight and the impact of ICH GCP Revision 3 on how sponsors manage their responsibilities.