top of page
All Posts


CEC Membership: Choosing the Committee
When selecting members for a Clinical Events Committee (CEC) it is so important to select individuals who can provide independent, expert, and unbiased adjudication of clinical trial events AND have the experience to understand the role of these adjudications. Here are some factors I consider when vetting potential CEC members.
Kelly Breuer
Jul 132 min read
Â
Â
Â


DIY Clinical Trial Monitoring Tracking Using Excel (if you can't afford CTMS)
Whether you use a CTMS or Excel, tracking monitoring activities during the study is integral to protecting the rights, safety, and welfare of study subjects and staying on top of your study monitoring activities
Kelly Breuer
Jul 132 min read
Â
Â
Â


Airport Review: MSP Minneapolis/St. Paul, MN Terminal 1 (hub, sweet hub)
Minneapolis–Saint Paul International Airport (MSP) is clean, efficient, and traveler-friendly, with quick security lines, great dining options, and easy navigation. A top choice for both domestic and international travelers seeking a smooth airport experience
Kelly Breuer
Jul 122 min read
Â
Â
Â


Clinical Trial Accounting Accrual: Why It Matters and How to Do It Without Losing Your Mind
Clinical trial accounting accruals help startups track real-time study costs, manage budgets, and stay investor-ready. With lean teams and tight cash flow, building a simple, consistent accrual process is key to demonstrating financial control and audit readiness.
Kelly Breuer
Jul 72 min read
Â
Â
Â


Informed Consent Forms: common issues
Informed Consent Forms are a common source of issues in clinical trials. From missing elements to outdated versions, these common ICF issues can impact your study timeline- unless you catch them early. Here’s a few of the most frequent issues I've seen and how I try to avoid them.
Kelly Breuer
Jul 75 min read
Â
Â
Â


Airport Review: Missoula, MT (MSO)
Modern, efficient, and scenic, MSO offers friendly staff and amazing mountain views, though dining and flight options are limited and the security wait time can be long
Kelly Breuer
Jul 32 min read
Â
Â
Â


How to Review Essential Documents (with Regulatory References)
Collecting and reviewing Essential Documents in clinical trials ensures study staff are qualified and compliant. This post covers key checklist items and regulatory references to help teams prepare for audits, confirm experience, and align roles with delegation logs for inspection readiness.
Kelly Breuer
Jul 34 min read
Â
Â
Â


What Is a Clinical Event Committee (CEC) and What Does a CRA/CSM Do in the CEC Process?
The Clinical Event Committee (CEC) independently reviews key clinical events to ensure consistent, unbiased study endpoint assessment. CRAs and Clinical Study Managers (CSMs) play a vital role by ensuring timely event reporting, source document collection, and packet submission
Kelly Breuer
Jul 14 min read
Â
Â
Â


Site Initiation Visit (SIV) Scheduling and the SIV Letter: What You Need to Know
The Site Initiation Visit (SIV) is a critical step in starting a clinical trial at a site. Scheduling requires the collection key documents and staff availability. Once confirmed, the SIV letter outlines the agenda, meeting details, required training, and pre-visit tasks. Whether in-person or virtual, a well-planned SIV ensures the site is prepared to begin enrollment, follow protocol requirements, and maintain regulatory compliance.
Kelly Breuer
Jun 292 min read
Â
Â
Â


A Day in the Life of a hybrid Clinical Research Associate and Clinical Trial Manager
What happens during a day in my life- read on to find out!
Kelly Breuer
Jun 202 min read
Â
Â
Â


What Does a Clinical Research Associate Really Do?
What Does a Clinical Research Associate Really Do- we act as a data reviewer, project manager, and compliance expert rolled into one, ensuring the data collected from a clinical trial is accurate, complete, and ethically obtained.
Kelly Breuer
Jun 162 min read
Â
Â
Â


5 Lessons You Only Learn Working at a Start-Up- Clinical Operations edition
At a start-up medical device company, clinical operations build processes, collaborate across teams, and adapt quickly under pressure. With limited resources and tight timelines, we become resourceful problem-solvers. The work is fast-paced and challenging but deeply rewarding.
Kelly Breuer
Jun 153 min read
Â
Â
Â


From Start-Up Chaos to Clinical Milestones: Why I Chose Clinical Research
What happens when you dive headfirst into clinical trials at a start-up company? You learn fast, adapt faster, and discover how powerful clinical research can be. In this post, I’m sharing both my career journey and why I chose a career where every detail, deadline, and decision can impact lives.
Kelly Breuer
Jun 153 min read
Â
Â
Â
bottom of page