Articles by Sandra "SAM" Sather and Jennifer Lawyer

1. CRO Oversight Essentials 6/30/2022

   Sponsors need to proactively identify and manage the risks involved with working with a CRO. This kind of oversight can help reduce the likelihood of negative consequences that could impact the quality of a trial.

2. An ISO 14155:2020 Primer — Good Clinical Practice For Medical Device Trials 2/2/2021

   An analysis of the recently released ISO 14155:2020, "Clinical investigation of medical devices for human subjects — Good clinical practice," a standard developed to guide clinical research professionals during the design, conduct, recording, and reporting of clinical trials related to the safety and effectiveness of medical devices.

3. Safeguarding Participant Data During Risk-based Monitoring — Practical Considerations 9/22/2020

   With risk-based monitoring becoming more common, and with sponsor/CRO monitors reviewing electronic source data remotely, many questions have arisen regarding what security measures need to be in place to ensure the protection of study participants’ data.

4. Remote Monitoring In The Wake Of COVID-19 — Practical & Regulatory Considerations 6/30/2020

   In the long term, as we move into the reopening phases of COVID-19, faced with increased expenses and the challenges with on-site monitoring, clinical research professionals need to ensure their quality management systems have the flexibility for the new normal for site management.

5. Clinical Trial Root Cause Analysis: Can't We Do Better Than Five Whys? 1/15/2020

   Root cause analysis should be a chance to take a step back and try to understand why an issue occurred, and to think critically, understand the process, and determine how the issue came about. The Five Whys approach can lead us to a simple “root cause” and action, but does it enable us to really understand the issue?