Four Critical CT Data Points

Efficiency is key in clinical trials, and one way to derail those streamlined trials is to waste time on non-critical data points. If a site and sponsor expend energy gathering information that isn’t vital, they have less time to discern and apply the metrics that matter. A few of those important data points include: Pinpointing […]

Demonstrating Your Value to Sponsors

Understanding what sponsors want from their relationships with both CTOs and specific sites boils down to one thing: reducing risk. Enrolling and retaining patients is a long process that’s also the most critical component of a successful trial. Sponsors want to be ensured that performance is being monitored and reported upon accurately so they can […]

3 Steps for Better Site Metric Tracking

Each year, poorly performing sites cost sponsors and CROs billions of dollars. Sponsors and CROs are adjusting strategies to solve this problem, including improving their site selection processes. As a result, to win studies, your site must now show that it’s not only easy to work with, but also a money-saving solution. Demonstrated success is […]

How to Enhance ALCOA Data Integrity with eSource Tools

ALCOA outlines the FDA’s expectations for data integrity. It defines the types of records the government wants: Attributable, Legible, Contemporaneous, Original, and Accurate. What these guidelines don’t prescribe is a standard for clinical sites to collect this data. The FDA makes no differentiation between paper and eSource systems, but that doesn’t mean that you shouldn’t […]

3 Ways to Improve Screen Failure Reconciliation

Standardized screen failure data is hard to find; results across different types of studies are rarely published. One review of clinical trials for genitourinary cancer placed the mean screen failure rate at approximately 20 to 30 percent; other studies for Alzheimer’s posted rates of 70 to 80 percent. Even rates on the lower end of […]

So You’ve Heard of ALOCA…but What Does it Really Mean?

To run a successful clinical research organization, data integrity needs to be an essential part of any clinical trial. While maintaining GCP, clinical research sites also need to be sure that their source data follows FDA guidelines and standards for record keeping. Whether its electronic or paper source documentation, standards require that research sites follow […]