Six Sigma Principals for Process Improvement in Clinical Research
Marina Malikova, Ph.D., MSci, MA, CCRA, RAC- Executive Director, Surgical Translational Research: Operations and Compliance.
Dr. Malikova has over fourteen years of experience in the clinical research field. She has managed Phase I – IV studies involving investigational drugs, devices, and biologics. She has worked on Industry-sponsored and Investigator-initiated trials in the fields of Surgery, Cancer Diagnostics, and Interventional Radiology.
Dr. Malikova graduated from the Institute of Biochemistry, Russian Academy of Science, in Moscow, Russia with a Ph.D. in Biochemistry. She also holds a Master’s Degree in Clinical Investigation and Project Management Certification from Boston University.
In her current role as Executive Director, Dr. Malikova manages research efforts in 13 divisions of the Department of Surgery at Boston Medical Center. She is responsible for clinical trials and basic biomedical research operations, quality assurance, risk management, safety monitoring, strategic planning, and micro-management of research programs. She provides guidance and oversight to the Project Managers, Clinical Research Associates (CRAs), Clinical Research Coordinators (CRCs), and laboratory staff. She advises faculty/staff on protocol and informed consent writing; assists with BU IRB applications and submissions; provides oversight for data user agreements, cost coverage analysis and budgets development, contracts and licensing for clinical research; and ensures compliance.
Dr. Malikova has 10 years of teaching experience as an Instructor for Clinical and Biomedical Sciences Program, Metropolitan College. She has developed and taught several courses such as Design and Conduct of Clinical Trials, Drug Development, Introductory Pharmacology, Clinical Trials Management at Boston University, School of Medicine.
She also served as an Instructor of the Good Clinical Practices (GCPs) course for the Master of Science Program in Clinical Investigation, Division of Graduate Medical Sciences, Boston University, School of Medicine since Summer, 2012.
Dr. Malikova is a member of the Association for Clinical Research Professionals (ACRP), Drug Information Association (DIA), Regulatory Association Professionals Society (RAPS) and European Society of Radiology (ESR). Currently, she is serving as an Editor for SAGE publishing group and National Institute of Health (NIH) reviewer for grants and clinical trial proposals.
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.