ARTICLES BY SANDRA "SAM" SATHER AND JENNIFER LAWYER

  • 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.

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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.