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.

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

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.

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 From missing elements to outdated versions, these common ICF issues can impact your study timeline- unless you catch them early.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.

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.

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

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.