Clinical Trial Risk and Performance Management Summit
PLENARY SESSION |
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7:30 a.m. – 8:45 a.m. |
Breakfast |
8:45 a.m. – 9:00 a.m. |
Welcome Linda Sullivan, Co-Founder and Executive Director, Metrics Champion Consortium (MCC) |
9:00 a.m. – 10:00 a.m. |
Secrets to Implementing Successful Metric Programs
Keith Dorricott, Contractor for the Metrics Champion Consortium; Director, Dorricott Metrics & Process Improvement Limited Michael Fitzpatrick, Associate Director, Sarepta Ravin Warnakulasuriya, Senior Director, Vertex Pharmaceuticals Nancy Dynes, Metrics Consultant, Eli Lilly and Company |
10:00 a.m. – 10:15 a.m. |
Break |
10:15 a.m. – 11:00 a.m. |
Secrets to Implementing Successful Metric Programs (continued) |
11:00 a.m. – 12:00 p.m. |
KEYNOTE ADDRESS Tracking the Patient Engagement Movement and its Impact on Clinical Research Execution Kenneth Getz, Director of Sponsored Programs and Associate Professor, Tufts University; Founder and Board Chair, CISCRP |
12:00 p.m. – 1:00 p.m. |
Lunch |
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The event now splits into two tracks, vendor oversight and risk-based quality management. Please choose the track that will help you the most. |
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VENDOR OVERSIGHT |
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1:00 p.m. – 1:45 p.m. |
WELCOME
Liz Wool, President, Wool Consulting Group, LLC |
1:45 p.m. – 2:15 p.m. |
PRESENTATION Managing the Business of Inefficient Oversight: How Heavy (or Light) is Your Touch When it Comes to Overseeing Vendors? Vendor oversight is a hot topic these days as companies try to find implementation strategies to satisfy the ICH E6 (R2) vendor oversight guidelines. From formalized vendor riskbased selection criteria to oversight SOPs to complex vendor management plans, Sponsors are interpreting the guidelines in different ways to avoid negative inspection findings at all costs. From all vantages, taking a risk-based approach to vendor oversight makes good sense and should theoretically be more efficient … but is it?
During this session, the speaker will describe current industry practices on the complexities and implementation strategies through interpretation of a detailed survey specific to vendor oversight requirements. The results of this survey will be discussed at this session to spur additional conversation on current practices. In other words, this is vendor oversight: according to you. Todd Johnson, Principal Consultant, Halloran Consulting Group, Inc. Margaret Sabe, Principal Consultant, Halloran Consulting Group, Inc. |
2:15 p.m. – 3:00 p.m. |
PANEL Vendor Oversight Approaches and the Keys to Developing “Healthy” Sponsor/Vendor Engagements and Teams
Mary Brantner, Senior Director, Mallinckrodt Pharmaceuticals Maria Makarovskaya, Clinical Outsourcing Consultant, Voyager Therapeutics, Inc. Michele Weitz, Senior Director, Clinical Standards and Innovation, Clovis Oncology Leslie Sam, Independent Consultant, Former TransCelerate Member |
3:00 p.m. – 3:30 p.m. |
Break |
3:30 p.m. – 4:15 p.m. |
CASE STUDY An Evolving Approach to CRO Oversight — Challenges, Lessons and Takeaways
Jehan Poco, Manager, DSI David Anderson, Manager, DSI |
4:15 p.m. – 5:30 p.m. |
SMALL GROUP EXERCISE Vendor Oversight Case Example Instructions:
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5:30 p.m. – 6:30 p.m. |
NETWORKING RECEPTION |
6:45 p.m. – 8:30 p.m. |
MCC Member Dinner |
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RISK-BASED QUALITY MANAGEMENT |
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1:00 p.m. – 1:30 p.m. |
WELCOME
Keith Dorricott, Contractor for the Metrics Champion Consortium; Director, Dorricott Metrics & Process Improvement Limited |
1:30 p.m. – 2:30 p.m. |
PANEL Risk Management Emerging Practices and the Impact of ICH E6(R2) Updates
Sandra (SAM) Sather, MS, BSN, CCRA, CCRC Vice President, Clinical Pathways, LLC Steve Young, Chief Operations Officer, CluePoints Dr. Oleg Shevaldyshev, Associate Director Quality Assurance, PRA Health Sciences Kevin Douglass, Associate Director, DSI |
2:30 p.m. – 3:00 p.m. |
PRESENTATION Normalization of Key Risk Indicators and Quality Tolerance Limits for Risk Detection Steve Young, Chief Operations Officer, CluePoints |
3:00 p.m. – 3:30 p.m. |
Break |
3:30 p.m. – 4:15 p.m. |
PANEL SESSION Risk-Based Site Monitoring Emerging Practices
Duncan Hall, CEO & Founder, Triumph Research Intelligence, Ltd. Arturo Morales, Chief Technology & Data Officer, WCG Analgesic Solutions Diane Thornton-Chandler, Principal Centralized Clinical Research Specialist, MC2 Global Monitoring, Medtronic |
4:15 p.m. – 5:30 p.m. |
BREAKOUT GROUP DISCUSSIONS Measuring Centralized Monitoring and Site Monitoring Keith Dorricott, Contractor for the Metrics Champion Consortium; Director, Dorricott Metrics & Process Improvement Limited Risk-Based Site Monitoring and Risk-Based Quality Management — KRIs & QTLs Steve Young, Chief Operations Officer, CluePoints Risk Management for Small Sponsors Sandra (SAM) Sather, MS, BSN, CCRA, CCRC Vice President, Clinical Pathways, LLC Development and Use of a Risk Library Kevin Douglass, Associate Director, DSI Keeping the Risk Assessment Up to Date Duncan Hall, CEO & Founder, Triumph Research Intelligence, Ltd. |
5:30 p.m. – 6:30 p.m. |
NETWORKING RECEPTION |
6:45 p.m. – 8:30 p.m. |
MCC Member Dinner |
WHO WILL BENEFIT
This event is designed for professionals from pharmaceutical, biotechnology and medical device companies; CROs; and other clinical service providers who have responsibilities in the following areas:
- Clinical Operations/Management/ Research/Development
- Clinical Outsourcing/Vendor Management/Third-Party Management
- Clinical/Project Operations
- Performance Analytics/Management/Reporting
- Metric Reporting/Visualization
- Quality Management/Clinical Quality Management
- Compliance/Clinical Compliance/ Regulatory Compliance
- Monitoring/Site Management/Study Management
- Clinical Risk Assessment
- Centralized Monitoring / Risk-based Monitoring
- Good Clinical Practices
- Clinical Process Optimization
- Vendor Oversight
The event is also of interest to:
- Central, Imaging and ECG Labs
- eCOA/ePRO companies
- eTMF companies
- CTMS companies
- EDC companies
- Data aggregation and visualization companies
- Other Clinical Service Providers