Six Sigma Principals for Process Improvement in Clinical Research
Peggy J. Berry, MBA, RAC, is the President & CEO at Synergy Consulting where she provides consulting services to companies in all aspects of drug development. She also provides group and one-on-one training in drug development, regulatory affairs, and project management topics. Prior to founding Synergy Consulting, she was Vice President of Regulatory Affairs at Insmed where she was responsible for the development and implementation of global regulatory strategies and the management and oversight of the regulatory affairs department. She also worked as Vice President of Regulatory Affairs and Quality at Amarin and held a variety of senior-level positions at Dyax, MGI Pharma, AstraZeneca and Dey Pharma. She has also held Regulatory Affairs roles within two clinical contract research organizations and has worked in review divisions at the FDA. In addition, Ms. Berry is active in the Regulatory Affairs Professionals Society. She is the editor-in-chief of Fundamentals of US Regulatory Affairs, 6th edition (RAPS, MD 2010). Editor of “Choosing the Right Regulatory Career” (RAPS, MD 2010) and author of “Communication & Negotiation” (RAPS, MD 2011).
Managing clinical trials, of any size and complexity, requires strategic planning and efficient execution. In order to successfully deliver innovative therapies to patients with unmet medical needs the trial management guidelines need to be standardized further, and robust methods of evaluation of study protocol complexity developed in conjunction with risk management strategies and process improvement implementation.
In addition, effective process improvement can be the key to reducing delays and improving data accuracy. In clinical trials, turnaround time and data accuracy are critical. Likewise, paperwork-based errors in the clinical trial process – whether they occur at the sponsor level, the contract research organization (CRO) level or the institutional review board (IRB) level – can have serious downstream effects, negatively impacting study efficacy and time-to-market. It is essential, therefore, that all participants in clinical trials – sponsors, CROs and IRBs – take steps to improve both efficiency and accuracy.
In order to address these concerns, several successful organizations associated with the clinical trial industry have begun implementing Six Sigma principles. Developed in the early 2000s by Michael George, now the Director of the Institute of Business Entropy, Lean Six Sigma is a combination of two distinct ongoing business improvement practices, Lean and Six Sigma.
- Discuss evolving challenges with different phases of clinical studies for Sponsors, CROs, third-party vendors and sites
- Define areas in clinical research which need to maintain high-quality standards and discuss the Need for Improvement
- Understand the quality improvement process and strategies
- Discuss Six Sigma principals and methodologies
- Review how they can be applied to clinical research at the sponsors, sites, CROs and IRBs level
- Discuss how to optimize the process and improve efficiency and quality of research conducted
- Address strategic planning and budgetary consideration
- Determine critical factors for selecting and training clinical trial sites, vendors, contractors on Six Sigma methodology and principals
- Plan, develop and implement effective process improvement and study management strategies
Course Level - Intermediate
Who Should Attend
- Directors of Clinical Operations
- Medical Affairs specialists and leaders of this division
- Project Managers
- Staff from Pharmaceutical/Device Companies or Contract Research Organizations (CROs) involved with the management of clinical trials
- New clinical or other Project Team Leaders who will be managing projects
- Clinical, Regulatory, Research, and Department (R&D) Staff who will design clinical trial programs
- Physician investigators
- Clinical Research Coordinators (CRCs) and Clinical Research Associates (CRAs), Data Managers or others working in biomedical product development and/or interested in transitioning into clinical trials field
- Grant Administrators
- Regulatory Affairs
- Quality Control(QC), Quality Assurance Specialists
Why Should Attend
In this session, we will review the main principles, practices, and methodologies used in Six Sigma. Available resources involving applications of Six Sigma to health care, laboratory science, and clinical and research will be reviewed. Specific issues concerning the use of these techniques in different phases of clinical research will be identified and process improvement strategies discussed at the level of all parties involved in clinical research.