A Modern Approach to Risk-Based Monitoring
Sponsored by: Covance
- Risk Based Monitoring
- Clinical Trial
- Specimen Data
Date: 11 March
Time: 2PM London/10AM New York
Risk-Based Monitoring Opportunities Using your Specimen Data
We are in a new era of clinical trial operations that have increasing demands of running trials with reduced timelines and budgets. As companies are looking for the most efficient ways to streamline specimen management, we must redefine what traditional specimen management & risk-based monitoring (RBM) means. This includes taking a modern approach that maximizes the strategic possibilities of using a unified platform with supported services to inform decisions beyond specimen use and incorporate in-life sample reconciliation RBM opportunities. This is the new paradigm design to support flexibility and speed.
The words “Specimen Management” and “Risk-Based Monitoring” are not typically used in the same sentence. The complexity of clinical trials leads to many siloed functions in addition to siloed data systems. Identifying the critical data and processes to perform a risk assessment to develop a monitoring plan with specimen data would have been near impossible less than 5 years ago. That’s how fast the industry is changing and technology is advancing. And more importantly, vendors are listening to what their clients are requesting. Client engagement and client success are forging the pathway to delivering more effective solutions through high quality managed services.
When you expand the conversation of adopting RBM strategic plans into your specimen management processes you modernize the approach to in-life reconciliation. Think of the milestones you can manage by effectively knowing if patient specimen collections are occurring according the expected visit collection schedule. You can identify critical points of interest to ensure your test plan is on schedule to meet the planned advisory committee review. You can effectively address the demands of managing adverse events in a manner that would permit exploratory biomarker analysis in near-real time to prevent patients being discontinued from the study. Or perhaps, you want simply want to ensure site compliance so that you are not losing any specimens due to missed batch shipments or samples being left in the freezer that you find at the end of study. A well annotated biorepository goes beyond just having informed consent management processes in tandem with your clinical trial for reasons associated with testing samples outside of the primary and secondary objectives. Think about managing all the complex global rules and regulations associated with country specific needs. Pharma companies are being faced with increasingly high compliance demands from regulatory agencies especially in China. How are you managing the new HGR demands? An RBM plan doesn’t just require data and a process, it is the quality of the data and an expert team to manage the process that is the winning combination to optimize the technology solution.
In this webinar, let’s maximize opportunities by thinking outside the box. Let’s modernize our approach to risk-based monitoring and realize all the efficiencies there are to be gained. Transform your specimen management data into actionable insights that will help your organization save money and time by AVOIDING DELAY and MINIMIZING THE RISK!
Kate Dugan (facilitator),
Client Engagement Director
Kate joined Global Specimen Solutions in January 2017. She has over 20 years of industry and academic experience in research-based sample management. She possesses a unique combination of skills and experience in pharmacogenomics, clinical research, business development and operations to understand data needs and the business user to streamline processes and drive improvement. As a trained translational biomarker scientist, she has worked in academia, pharma, CRO, and central labs. As a scientific data strategist, she has led many transformational initiatives to implement innovative integrative solutions.
Her breadth of experience positions her well in her current role, Client Engagement Director, to advocate for the voice of the customer, to champion client business strategies, and to foster alliance relationships. She believes that successful partnerships are built with the right mindset and an innovative suite of technology tools and services
Kevin King (SME),
Vendor Engagement Director
Kevin joined GSS in April 2017. Starting his career as a data manager, he spent his first 16 years moving through a broad spectrum of operational and information technology roles at Quintiles Laboratories [Q2 Solutions]. His combined 22 years of experience includes several years working to develop systems to support biorepository operations and molecular diagnostic sample management and reporting. Kevin has proven success working to ensure processes and technological systems are aligned to business strategy and scalable to meet operational demands.
Mr. King has an exceptional ability to identify and develop solutions which not only meet the immediate needs of the customer, but also anticipate future needs, as dictated by industry trends and technological advances. His understanding of the challenges facing data management departments in large global organizations as well as in small, entrepreneurial laboratories enables him negotiate best possible outcomes for the customer and the vendor. He can help turn your data into information which is both substantive and actionable.
Key Learning Objectives
- Learn how and where to mitigate risk with in-life sample reconciliation
- Understand the sense of urgency for milestone management
- Realize the value opportunity of a well annotated biorepository
- Appreciate the level of effort to harmonize and normalize across vendor data
- EVP/ VP/ Head/ Director/ Manager/ Associate Director of Biospecimens
- Specimen Management
- Clinical Specimen Management
- Biomarker Scientist
- Translational Medicine
- Clinical Pharmacology
- Clinical Operations
- Global Development
- Clinical Innovation
- Informed Consent Management
- Genomics Policy
- Data Management