Start here.

To help you navigate this blog, below is a linked table of contents with descriptions for each post. And then each post ends with a link that will take you back to this page.

1. Introduction:

   1. Clinical trial complexity is the main driver of a need for a systematic focus on quality and risks. What's causing it?

   2. Understand the fundamentals of quality and risk and how they are related.

   3. Ideal Results: a take on linking the drug development program goals to the quality and risk concepts that drive each study.

      
      

2. Quality by Design (QbD):

   1. The Quality by Design introduction is focused on understanding the goals of QbD and considerations for evaluating quality in a clinical trial.

   2. Critical to Quality factors and Quality Tolerance Limits are central to QbD principles, so I spend some time explaining them.

   3. This general Quality by Design process utilizes practical approaches to drive study team focus around quality.

3. Risk-Based Quality Management (RBQM):

   1. Risk Assessment 101 covers a high-level process and links the value to RBQM.

   2. The RBQM "for dummies" title might be hyperbole, but I do try to simplify the concept.

   3. Key Risk Indicators are certainly important to being proactive and risk averse.

   4. This KRI definition process is meant to be straightforward and effective.

   5. This RBQM process is meant to help you figure out a game plan when it comes to introducing RBQM in a practical way for your trial.

      
      

4. Other: Clinical Data Science, Company Culture, Technology and Knowledge Management...

   1. I'm excited to post on these topics, but just like solid QbD and RBQM processes, I need to focus and prioritize based on what is most impactful and what makes the most sense to cover, in what order. Plus I refuse to use AI so you'll have to wait :).

COMING SOON posts: I will be adding content weekly, trying to maintain a logical order that follows the development of processes and builds off of prior topics. Once I have the basics posted for each category, I'll return to prior categories and add more content on related topics, stories and experiences (which I'll tease in the "Coming soon" post for each section).

I hope you can find some useful information and tips for practical application to help drive your people, processes and technologies forward. And please reach out with suggestions or to discuss my consulting services -the footer "contact me" links to my email.

Thanks,

Brien