Sandra "SAM" Sather and Jennifer Lawyer
Sandra “SAM” Sather, MS, BSN, CCRC, CCRA, is an industry-leading consultant whose mission is to promote clinical quality systems for sponsors/CROs and investigators/research institutions. She has over 35 years of clinical experience, with a BS in nursing and an MS in education with a specialization in training and performance improvement. Sather is the VP of Clinical Pathways, a consulting firm with clients in the medical device and pharmaceutical industries located in the Research Triangle Park area in North Carolina. She is dual certified by the Association for Clinical Research Professionals (ACRP) for over 15 years (CCRA and CCRC) and a current ACRP Fellow, which is awarded to individuals who have made substantial contributions to the Association and the industry at large. Learn more at www.clinicalpathwaysresearch.com.
As the operations director at Clinical Pathways, Jennifer Lawyer’s focus is on implementing processes to improve quality and on-time delivery for eLearning development and project management. As an eLearning project manager, she ensures the day-to-day processes run efficiently and products are high-quality and completed on time. Prior to joining Clinical Pathways, Lawyer worked as a clinical research professional and a private duty nurse. She holds a BS in psychology, an AS degree in nursing, and two clinical trials research associate certificates (core competencies and advanced topics). She is a member of the Association of Clinical Research Professionals (ACRP) and is working on her professional certification.
ARTICLES BY SANDRA "SAM" SATHER AND JENNIFER LAWYER
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![GettyImages-1204642219]( "CRO Oversight Essentials")
CRO Oversight Essentials6/30/2022Sponsors 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.
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![Book]( "An ISO 14155:2020 Primer — Good Clinical Practice For Medical Device Trials")
An ISO 14155:2020 Primer — Good Clinical Practice For Medical Device Trials2/2/2021An 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.
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![iStock-1152035902]( "Safeguarding Participant Data During Risk-based Monitoring — Practical Considerations")
Safeguarding Participant Data During Risk-based Monitoring — Practical Considerations9/22/2020With 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.
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![Telehealth Remote Healthcare]( "Remote Monitoring In The Wake Of COVID-19 — Practical & Regulatory Considerations")
Remote Monitoring In The Wake Of COVID-19 — Practical & Regulatory Considerations6/30/2020In 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.
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![why-question-fog]( "Clinical Trial Root Cause Analysis: Can’t We Do Better Than Five Whys?")
Clinical Trial Root Cause Analysis: Can’t We Do Better Than Five Whys?1/15/2020Root 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?
