From Episode 195 with Archana SahIn this clip of the larger interview with Archana Sah, she covers the critical phases and elements of clinical trials—from phase one focusing on safety to phase three assessing effectiveness in diverse populations. Key aspects include the importance of the trial design, the role of comparator arms, regulatory requirements, patient recruitment, and the cultural preferences that influence trial protocols. The episode provides an in-depth look at how data is collected and analyzed to ensure the safety and efficacy of new drugs.

Introduction to Clinical Trials00:26 Phases of Clinical Trials02:09 Designing Oncology Trials04:00 Protocol Design and Regulatory Approval05:27 Patient-Centric Considerations06:25 Vendor Roles and Statistical Analysis

197 - Quality Agreements Explained: How to Protect Yourself When Things Go Wrong

Hello Combi-Nation!

Our industry fee complicated sometimes. Drugs, devices, clinical trials, submissions, sterilization validation, design control, risk management, market access reimbursement, the list goes on. 

My name is Subhi Saadeh. I've spent over a decade in medical device, pharma, and combination product development. My goal is mastery, so this podcast is to ask questions I have to people who may have the answers. 

Whether you're background is Pharma, Device or both, I invite you to listen and together we can simplify by Combinating!