Welcome.

I hope you find some useful nuggets in my posts. "Start here" is a table of contents and a great place to start. Otherwise you can click, tap, scroll and search to your heart's content!

Please note that I will be adding new content as mentioned in "Coming Soon" posts for each section.

All Posts

Realizing the Promise of Digital Biomarkers

The industry is ready to leverage all types of patient captured data and information in order to support better understanding of a drug's...

Brien Hawley

Jul 9, 20255 min read

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...

Brien Hawley

Jun 25, 20252 min read

Risk-Based Quality Management (RBQM): Step-by-Step

Here's a primer for RBQM . And here are general steps for implementing RBQM for your study: Initiate your study-level Quality by...

Brien Hawley

Jun 24, 20255 min read

A Key Risk Indicator (KRI) Definition Process

Hopefully you have a sense of what KRIs are, but if not check out this post . Now let's look at a potential process for defining,...

Brien Hawley

Jun 24, 20252 min read

Key Risk Indicators (KRIs): your backbone for operational success

A well-defined KRI process can have huge impacts on clinical trial quality and efficiency. According to the Transcelerate definition "A...

Brien Hawley

Jun 24, 20254 min read

Risk-Based Quality Management for Dummies (like me!)

RBQM is officially promoted by the FDA. It's officially promoted by the EMA. And by the way, it just makes sense: Understand and manage...

Brien Hawley

Jun 24, 20253 min read

Quality and Risk: A match made in clinical research heaven.

We will spend some time reviewing quality and risk on this website individually, but it can be helpful to understand how they are...

Brien Hawley

Jun 24, 20251 min read

Critical-to-Quality factors and Quality Tolerance Limits: what are they and how do we choose?

To start, here's a definition of Critical-to-Quality (CtQ) factors from ICH E8 (R1) [1] : “ A basic set of factors relevant to ensuring...

Brien Hawley

Jun 24, 20254 min read

A Quality by Design Process for Studies

Quality by Design (QbD) is a broad approach and way of thinking. During the process of evaluating Quality by Design, Critical-to-Quality...

Brien Hawley

Jun 24, 20255 min read

Quality by Design (QbD) Intro: Let's get practical and tactical.

If you want to read up and learn more about QbD, here are some great resources: Introductory article from DIA ICH E8 R1 CTTI website with...

Brien Hawley

Jun 24, 20257 min read

Risk Assessment 101

If you can define a robust risk assessment process, then you can build out your Risk-Based Quality Management approach to include this...

Brien Hawley

Jun 24, 20255 min read

Ideal clinical trial results: What does success look like?

High quality clinical trial data for decision-making is the ultimate goal of running a study, but it can only be achieved if you define...

Brien Hawley

Jun 24, 20252 min read

Why can't we simplify our studies, and therefore our lives?

Complexity: it's not just for breakfast anymore. Think about the evolution of species, the advancement of technology since the...

Brien Hawley

Jun 24, 20254 min read

Coming Soon

I am excited to post about the following Clinical Data Science topics: Overview of CDS, evolution and current approaches Outliers, trends...

Brien Hawley

Jun 23, 20251 min read

Coming soon

I look forward to adding posts related to technology: The clinical research "tech stack" eSource: why is it better? how is it riskier?...

Brien Hawley

Jun 23, 20251 min read

Coming soon

I look forward to posting on the following topics: How do we continuously do better? Knowledge is power. Unlock it. Kaizen basics...

Brien Hawley

Jun 23, 20251 min read

Coming soon

I look forward to posting about the following topics related to culture: A Risk-driven culture Customer Success as a culture Effective...

Brien Hawley

Jun 23, 20251 min read