ICH E6 (R3) CALLS FOR CRITICAL THINKING AND OPEN DIALOGUE ABOUT QUALITY
CROs have long been seen as the driving force behind the adoption of innovative clinical operations technology, but beyond just technology, opportunities for innovation are borne out of the realization that leading CROs are sitting on a wealth of actionable data and expertise which can be leveraged into data driven decision making on a large scale, from starting clinical trials through to execution.
ICH E6 (R3) reinforces this proactive stance and introduces the concepts of Quality by Design (QbD) and critical thinking. The guidance specifically calls for establishing a culture that supports critical thinking and open dialogue about quality that goes beyond reliance on tools and checklists.
Applying critical thinking during study startup is pivotal to improving study conduct overall. Proactive planning is essential to identifying what is needed to mitigate risk, ensure regulatory compliance, audit-readiness, and to avoid serious budget and timeline overages. As CROs fight to maintain market share and ensure long-term survival, those companies able to take these steps may by well-positioned to reap the rewards.
In this webcast, we will explore:
- The intended purpose of ICH regulations — to implement industry best practices and not to add additional burdens on clinical research staff.
- What organizations stand to gain from adopting the updated guidelines, versus the compliance and other costs they’re likely to incur.
- How, by applying critical thinking to risk management, organizations can improve their operational efficiencies by minimizing duplicate quality-assurance steps.
- Strategies for quick, relatively straightforward adoption of the new guidelines.
This webcast is applicable to sponsor and CRO roles who are responsible for:
- Site identification, feasibility assessment, selection and activation
- Clinical data management, collecting and evaluating trial metrics
- Project management of studies, process optimization and operational excellence
About the Presenters
Rob King brings more than 25 years of clinical research industry experience to his role as FHI Clinical’s Chief Operating Officer. King has extensive experience in global clinical operations and executive leadership, with a professional and academic focus in quality management and compliance. King holds a bachelor’s degree in psychology from the University of North Carolina at Wilmington and is certified in nonprofit management from Duke University.
Christina Lentz Larsen serves as a Director in the Data Management Innovation team of IQVIA’s Data Sciences, Safety and Regulatory division. In this role, Christina leads the standardization, simplification, and digitization of data management processes to transform the business, providing insight and guidance into IQVIA’s next-generation unified data and process platforms. She has over 20 years’ experience in the industry, across programming, data management, statistics, and risk-based monitoring, and has worked both domestically and internationally within the large pharma, CRO, and technology spaces. Christina graduated with a Bachelor of Arts degree in Mathematics, Cum Laude from Boston University and is a certified IQVIA Lean Practitioner.
Sheelagh Aird has extensive experience in clinical data management and biometrics, holding a BSc in Pharmacology and doctorate in Pharmacokinetics from the University of Bath, UK. Following the completion of her academic studies, Sheelagh moved into the pharmaceutical industry, working for large, medium, and small CROs, heading up data management and programming groups. Sheelagh established and co-owned a bespoke data management CRO for 16 years, conducting studies for multinational pharma and biotech companies alike, having been involved in all phases of clinical trials across many therapeutic areas, from the large pharmacogenomic studies to the small cell therapy and ATIMP studies. Since 2016, Sheelagh has led PHASTAR’s Data Operations team of Data Managers and Data Scientists.
Kirill holds a Medical Degree in Cardiology and before joining PSI in 2003, Kirill worked as a cardiologist and a sub-investigator in the St. Petersburg Institute of Cardiology. At PSI Kirill has worked in Clinical Operations and Project Management, and now is leading PSI Process improvement department. In this capacity he spearheaded the development and implementation of risk-based monitoring strategy as part of integration ICH E6 (R2) into PSI business practices.
Erika Stevens leads research transformation advisory and assurance services. In this capacity, she advised cancer centers, life sciences, AMCs, hospitals and health systems process improvement initiatives for productivity, quality and efficiency in operations, cross-functional relationships, administration, manufacturing and compliance. Her regulatory knowledge and quality oversight of the Code of Federal Regulations (CFR) includes, but is not limited to, GMP, GLP and GCP.
Ms. Stevens has over 20 years of research/ R&D experience, including over 12 years in research management serving in roles such as Vice President Research, Senior Managing Director, Director Clinical Trials Office, Director of Clinical Research, Interim Executive Director, Clinical Trials Office and Director of Research Operations. Ms. Stevens is a past president of the Association of Clinical Research Professionals (ACRP) New York Metropolitan Chapter. Ms. Stevens served as chair, for two terms, of the editorial advisory board for “The Clinical Researcher,” the peer reviewed journal publication for Association of Clinical Research Professionals (ACRP). Ms. Stevens is the Chair of the Associate Board of Trustees. Erika is a director for Brightpoint Care and served on the MAGI advisory board. She is also a frequent speaker on research operations and compliance practices at international conferences.
Additionally, she is a published author whose work appears in a variety of peer journals including the American Journal of Obstetrics & Gynecology, The Monitor, Clinical Researcher, Regulatory Focus, Applied Clinical Trials, Clinical and Translation Science and the Journal of Mental Health and Aging.
Erika Stevens leads research transformation advisory and assurance services. In this capacity, she advised cancer centers, life sciences, AMCs, hospitals and health systems process improvement initiatives for productivity, quality and efficiency in operations, cross-functional relationships, administration, manufacturing and compliance. Her regulatory knowledge and quality oversight of the Code of Federal Regulations (CFR) includes, but is not limited to, GMP, GLP and GCP.
Ms. Stevens has over 20 years of research/ R&D experience, including over 12 years in research management serving in roles such as Vice President Research, Senior Managing Director, Director Clinical Trials Office, Director of Clinical Research, Interim Executive Director, Clinical Trials Office and Director of Research Operations. Ms. Stevens is a past president of the Association of Clinical Research Professionals (ACRP) New York Metropolitan Chapter. Ms. Stevens served as chair, for two terms, of the editorial advisory board for “The Clinical Researcher,” the peer reviewed journal publication for Association of Clinical Research Professionals (ACRP). Ms. Stevens is the Chair of the Associate Board of Trustees. Erika is a director for Brightpoint Care and served on the MAGI advisory board. She is also a frequent speaker on research operations and compliance practices at international conferences.
Additionally, she is a published author whose work appears in a variety of peer journals including the American Journal of Obstetrics & Gynecology, The Monitor, Clinical Researcher, Regulatory Focus, Applied Clinical Trials, Clinical and Translation Science and the Journal of Mental Health and Aging.
Ms. Stevens holds her B.A. from the University of Vermont, her M.A. from Case Western Reserve University and her M.A. from Temple University. She also holds a Graduate Certificate in Gerontology from Case Western University.
Elvin is a recognized industry expert in clinical trials, having over 20 years of experience working as a clinical business analyst consultant at major pharmaceutical companies, including, Hoffmann-La Roche and Johnson & Johnson. Elvin works as a product strategist and system architect in Oracle Health Sciences effort to optimize Study Startup. Elvin is the co-chair on the TMF Reference Model Exchange Mechanism and holds a master of science in industrial engineering from Aalborg Universitet.
