Entries by Beth Harper

Analyzing Protocol Deviations Before Retraining

Protocol deviations can cause significant problems during clinical trials, forcing sites and sponsors to direct time and resources toward investigating and addressing them, potentially delaying completion of the study. And […]

Preemptive Protocol Analysis: Reducing the Need for Retraining

When things go wrong during a clinical trial, retraining of staff is often the go-to response to correct the problem. But rather than using training as a band-aid for every […]

Bringing Protocols to Life to Reduce Site and Patient Burdens

In a world where clinical trials are growing larger and protocols more complex, it’s increasingly important that study sponsors make sure to get their protocols right from the start to […]

Decentralized Clinical Trials: Balancing Patient and Site Needs

Decentralized clinical trials (DCTs), including hybrid studies, have become the latest trend in pursuit of more patient-centric trials. But the full value of DCT methods and technologies may be dependent upon specific patient characteristics and individual site capabilities. Rather than assuming that use of DCT methods is beneficial to all patients, for instance, sponsors and research sites might do better to look closely at their specific patient cohorts to determine what individuals in those groups truly need.

Correcting Site Enrollment In 3 Steps

Patient enrollment is a common subject of discussion among both sponsors and research sites. Challenges to enrollment can be myriad, and the root causes are hard to pin down. But […]

Reducing Protocol Deviations With Training-Based Metrics

Protocol deviations can have a detrimental effect on new drug development, adding to costs and time to clinical trials and even putting the acceptability of data generated during a study […]

SIVs: Identify Skill Gaps Before Retraining

As a former CRA, I have spent the better part of my career mentoring, teaching, and helping CRAs become competent at monitoring clinical trials to ensure compliance with protocol and […]

Maximizing Site Enrollment with Improved Protocol Comprehension

Sponsors and CROs trying to achieve better enrollment in clinical trials often overlook the most essential stakeholder in the process — the investigative sites that implement the trials and interact with the patients throughout the process

The Fallacy of Footnotes Within Clinical Protocols

As part of our series covering all the do’s and don’ts surrounding protocols, I wanted to call attention to one of the greatest urban legends in clinical research…the requirement to […]

101 Things That Could Go Wrong if You Don’t Get Your Training Right

Although it can be tricky to acquire proper clinical site training, inadequate planning for a research study’s training needs will create unnecessary, avoidable costs down the road. Let’s take a […]