Barnett International's Core Curriculum courses are comprehensive role-based clinical research training programs designed to provide industry professionals with hands-on training in a dynamic virtual setting. Held four times a year during our “Clinical Research Training Weeks,” courses offer clinical research-focused, performance-based training and core competency development.
Optimizing Protocol Design and Strategies to Achieve Efficient, Lower Cost Trial Execution
Upcoming Courses
This course will explore the challenges clinical teams face in developing protocols to ensure that the right patients are enrolled and that the right data are collected to demonstrate a drug is safe and efficacious, while at the same time managing study costs and study complexity, especially in trials that involve imaging and interventional procedures. Key factors to consider when developing protocols and techniques to minimize complexity, while at the same time ensuring trial success, will be discussed. This course will also identify pre-award processes and institutional approaches to increasing fiscal return and mitigating fiscal compliance risk for clinical trials. The ability to develop comprehensive budgets and ensure billing compliance for clinical trials is challenging for many clinical sites. Poor financial planning/forecasting and undefined billing compliance practices are associated with increased risk leading to deficits and Office of Inspector General (OIG) investigations. Strategies for covering true costs related to protocol design and multi-disciplinary approaches will be discussed.
- Assess study protocol for complexity and identify potential risks
- Describe the processes for fiscal oversight of clinical trials
- Recognize key performance indicators for managing fiscal/regulatory activities
- Apply leading practices to coverage analysis and financial oversight
- Perform cost estimation for a project and develop a schedule for completion of milestones
- Establish systems for quality control and monitoring of clinical trials
- Identify resources needed to complete projects and assign roles and responsibilities
- Perform cause-effect analysis for identified risks and develop mitigation strategies
- Personnel involved in the development of clinical trial protocols
- Project Managers and Project Team Leaders
- Clinical Research Associates
- New Clinical, Regulatory, and Department Staff who will design clinical trial programs
- Grant Administrators
- Medical Writers
The course will be led by one of the following instructors:
Marina Malikova, Ph.D., M.S., M.A., C.C.R.A.
Click here for complete trainer biographies
Day 1: 8:30 a.m. – 5:00 p.m.
- Introduction to the Project Life Cycle
- Study Protocol Design, Risk Analysis, and Templating
- Process Mapping as a Planning and Management Tool
- Scope, Timeline Management, Monitoring, Milestones
Day 2: 8:30 a.m. – 5:00 p.m.
- Development of Project Budgets and Cost Estimation Techniques
- Tracking Expenditures, Aggregate Spend, and Transparency Reporting in Clinical Trials
- Risk Management and Implementation of Strategic Project Management Concepts in Clinical Trials
- Quality by Design (QbD) Principles, Risk-Based Monitoring, and Developing Key Performance and Quality Indicators (KP-QIs)
- Communication and Team Building
- Contractors: Managing Outsourcing
- Identify project issues/risks
- Perform cause-effect analysis and develop risk management strategies
- Develop a preliminary Quality by Design (QbD) strategy and apply a Quality Risk Management (QRM) perspective to develop baseline quality metrics and key risk indicators
- Perform cost estimation and establish clinical research study schedules
Registration fees include assorted breakfast items that will be available each day ½ hour prior to the start of the seminar. Also included is a Networking Lunch that will be served each training day.
Special rates are available for multiple attendees from the same organization. Contact Melissa Dolen at 781-972-5418 to discuss your options and take advantage of the savings.
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Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 15 hours (1.5 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test and program evaluation. Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion. ACPE# 0778-0000-15-088-L01-P. Released: 1/16.
Hold this course at your company!
For more information, contact Naila Ganatra at (215) 413-2471.
