Charles "Chuck" Sather’s current focus of consulting is to promote efficiency in remote and on-site Monitoring and Auditing in a balanced, fair, and amiable manner. He has over 30 years of clinical experience with a Bachelor of Science Degree in Nursing and has been certified by the Association for Clinical Research Professionals (ACRP) as a CCRA for approximately 15 years. He is a frequent speaker at industry conferences, has authored multiple courses for clinical research training programs in various functional areas, and has been an Item Writer on ACRP’s Exam Committee. He specializes in:

• The remote and on-site monitoring of pediatric and adult pharmaceutical, biologic and medical device clinical trials

• Regulatory inspection preparation and post audit Root Cause Analysis, Gap Analysis and CAPA development

• SOP and monitoring tool development  

• And in compliance and data management auditing.

In 2002 he co-founded Clinical Pathways (CP), LLC with Sandra "SAM" Sather.

SAM has been in the industry for almost 30 years. She has worked for sites, Sponsors, and CROs, including roles as a study coordinator, site director, monitor, auditor, quality manager, director of clinical operations, director of monitoring, Quality Inspection Readiness Lead, and trainer. SAM is a well-known GCP and clinical quality system subject matter expert with a focus on inspection readiness, vendor management and risk-based quality management. SAM is a frequent speaker at industry conferences, and a contributor and author to many GCP publications. She co-owns a GCP consulting and training firm in Research Triangle Park in North Carolina since 2002 that services small to large pharma, biologic and medical device companies, technology vendors, research sites, and CROs.

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 product management. As an eLearning Product Manager, she ensures the day to day processes run efficiently and products are high-quality, per specifications, and completed on time for delivery to the client or customer. She developed the hiring and onboarding procedures for new hires and the company SOPs. Jennifer also supports a variety of projects including GxP inspection readiness, GCP auditing, and co-authoring GCP publications. Prior to her position at Clinical Pathways, Jennifer worked as a clinical research professional and a private duty nurse and holds a Bachelor of Science degree in Psychology, an Associate of Science degree in Nursing, and two Certificates in Clinical Trials Research Associate - Core Competencies and Advanced Topics.

MAIN ADDRESS: 3606 Stonegate Dr. Chapel Hill, NC 27516

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