A Databases Advancing Healthy Volunteer Through Inclusive Recruitment Practices
A Databases Advancing Healthy Volunteer Through Inclusive Recruitment Practices Healthy volunteer databases are foundational to early-phase clinical research, yet many remain outdated and demographically narrow. Historically, registries have drawn from limited populations, producing data that fails to reflect real-world diversity. This lack of representation undermines scientific validity and creates downstream challenges for sponsors and regulators […]
How the FDA’s 2025 Guidance Updates Are Reshaping Clinical Trials
How the FDA’s 2025 Guidance Updates Are Reshaping Clinical Trials The FDA’s 2025 draft guidance updates are set to change the way sponsors and their partners approach early-phase clinical development. For CROs, these updates aren’t just regulatory checkpoints, they represent new expectations around trial design, execution, and long-term planning. As sponsors seek CROs who […]
Why Data Entry Is the Backbone of Every Clinical Study
Why Data Entry Is the Backbone of Every Clinical Study In clinical research, data is the backbone of every trial. Sponsors, regulators, and patients all depend on its accuracy to guide decisions about safety, efficacy, and approval. Yet one of the most critical steps in this process, data entry, is often underestimated as “just” administrative […]
Seeing What Topicals Really Do at the Microscopic Level
Seeing What Topicals Really Do at the Microscopic Level In clinical research, every decision about product development hinges on data. For topical drugs and dermatology products in particular, gathering that data has always been a challenge. How do you know, with certainty, that an active ingredient is doing what it is supposed to do once […]
What CROs Overlook When Recruiting for Long In-House Stays
What CROs Overlook When Recruiting for Long In-House Stays Recruitment for clinical trials is never simple, but when studies require participants to remain in a clinic or research facility for extended periods, the challenges multiply. Long in-house stays, common in early-phase pharmacology trials, demand more than a standard recruitment plan. They require a retention strategy […]
Strategies for Ongoing Engagement from Subjects During Clinical Trials
Strategies for Ongoing Engagement from Subjects During Clinical Trials Recruitment is only the first hurdle in a successful clinical trial. Maintaining participant engagement and ensuring compliance throughout the study are equally critical. High dropout rates or protocol deviations can jeopardize data integrity, delay timelines, and increase costs. For early phase CROs, proactive strategies to keep […]
What Makes a CRO Audit-Ready All Year Long?
What Makes a CRO Audit-Ready All Year Long? The phrase “Regulatory audit” can cause anxiety into even the most seasoned CRO professionals. For many, who see an audit as an isolated event, it conjures images of frantic, last-minute preparations, often referred to as “fire-drill audit culture.” This reactive approach, while sometimes seemingly effective in the […]