2K Clinical Consulting, Inc. is a firm that provides compliance training and services that promote inspection readiness in areas of GCP, GDP and GMP.
Areas of focus include:
• Clinical Trial Management
• Project Management
• Quality Management
• Inspection Preparation
• Monitoring and Site Management
• Document Management
• System Validation
• Quality Systems Inspection Technique (QSIT) of Medical Devices
The mission of 2K Clinical Consulting, Inc. is to ease the burden of GxP compliance and to transform the effectiveness of professionals and compliance systems worldwide.
2K Clinical Consulting, Inc. is the vision of former FDA Investigator, Kimberly Kiner, who empathized with facilities and sites that struggled with understanding and complying with regulations. After years in the field, Kimberly transitioned into the private sector and acquired international experience in compliance, monitoring and study management while she worked for pharmaceutical and invitro/medical device companies as well as CROs. This work experience is what sparked her desire to work as a consultant for organizations such as the Association for Clinical Research Professionals and the Society of Clinical Research Associates. Kimberly later went on to train providers such as Compliance Online and Fx Conferences. This exposure became the gateway to connecting with other experts and teaching professionals resulting in an engaging experience for clients that closes the gap in best practices within the realm of compliance.