Cambridge Healthtech Institute’s 5th Annual
Implementing Risk-Based Monitoring – Part 1
Integrating Quality into Clinical Trials
February 19-20, 2019
Poor quality and risk management of clinical trials significantly impacts the success, timeliness and cost-effectiveness of clinical trials. Cambridge Healthtech Institute’s 5th Annual “Implementing Risk-Based Monitoring – Part 1: Integrating Quality into Clinical Trials” conference provides lessons learned, case studies, and ample discussion on building and maintaining proper clinical quality management systems with emphasis on the latest quality standards and guidelines, including the recent ICH-E6 R2 addendum changes,
thereby ensuring higher quality clinical trials and laying the foundation for successful risk-based monitoring. The program will also focus on successful RBM implementation tactics employed by small and mid-sized organizations.
Day 1 | Day 2 | SCOPE Final Brochure | Quality, Monitoring Brochure
Stay on and attend Part 2 (Wed-Thurs): Implementing Risk-Based Monitoring – Part 2
Monday, February 18
9:00 am – 7:15 pm Registration Open (Convention Level)
2:00 – 5:00 pm User Group Meetings
Shared Investigator Platform User Forum
Trifecta Annual User Group Forum
5:00 – 6:15 pm Pre-Conference Plenary Keynote Panel &
Participant Engagement Award (Regency PQ)
6:15 – 7:15 pm SCOPE’s Kick-off Networking Happy Hour Hosted by CHI (Sponsorship Opportunities Available) (Pool Decks)
7:15 pm Close of Day
Tuesday, February 19
7:15 am Registration Open and Morning Coffee (Convention Level)
8:15 Opening Plenary Keynotes
9:35 Grand Opening Coffee Break in the Exhibit Hall (Plaza International Foyer)
10:35 Chairperson’s Remarks
Angie Maurer, MBA, Clinical Quality & Risk Management Consultant, GRAIL, Inc.
10:40 CO-PRESENTATION: Build a Clinical Quality Management System from The Ground Up
Brian Nugent, Senior Director, Clinical Compliance,
Angie Maurer, MBA, Clinical Quality & Risk Management
Consultant, GRAIL, Inc.
During this session we will discuss a case study where we built a CQMS from the ground up. We will discuss our evaluation, planning and implementation process. Also, we will share the findings and the steps we took to build the department,
current status and plans for the future. included in this presentation will be: 1. Background of the company, 2. Evaluation process of the company’s quality group, 3. Plan developed based on the evaluation findings, 4. Implementation
of a CQMS and an overall Quality Management System (QMS), and 5. Lessons learned.
11:40 A Risk Management Case Study: Evolution of Pfizer’s Integrated Quality Risk Management Plan and Realization of Risks
Sheri Kuss, Director, Clinical Quality Management, Pfizer
With clinical trial experience and the release of ICH E6 Revision 2, our Risk Management approach has evolved from the initial use of an excel-based plan to the creation of an electronic risk management system with reduced questions, risks
and the addition of Quality Tolerance Limits. The speaker will provide an example of studies where the prospective risks identified were analyzed for risk realization post-study. The retrospective look at the risks and identified study
issues has had an impact on risks, mitigations and controls of future studies as well as the overall risk management approach.
12:10 pm RBx: A Complete Risk-Based Approach to Clinical Trials - How ICH E6 (R2) is Driving the Industry to Realize Hope and Overcome Fear
Francois Torche, CEO, CluePoints SA
Since the initial publication of the ICH guidelines, the way clinical trials operate has changed significantly. The ICH E6 (R2), encourages sponsors to develop a prioritized, risk-based approach to both quality management & monitoring.
This session will shed light on how to achieve the “gold standard” for monitoring, study execution, and oversight, in line with ICH guidance.
12:40 Transition to Lunch
12:45 LUNCHEON PRESENTATION: Transforming Data Quality using Machine Learning
Stacey Yount, Vice President, Product, Medidata
Learn how to set your organization on a path to improved data quality across the clinical trial process using machine learning.
1:25 SCOPE Turns 10! Champagne and Dessert in the Exhibit Hall (Plaza International Ballroom)
2:05 Chairperson’s Remarks
Angie Maurer, RN, Clinical Quality & Risk Management Consultant, GRAIL, Inc.
2:10 CO-PRESENTATION: Operationalizing Quality
Alana Wriggins, Head, Site Management,
Ann Hegarty, Executive
Director, GSMO, Head PLs, CRO Oversight & Ph I Site Management, Allergan
We all have great ideas of what quality looks like in clinical trials and we have regulations and guidances as support. However, it seems the challenge remains in how and IF we operationalize quality. This session will focus on inspection
readiness from the beginning - from incorporating RBM to outsourcing strategies, all in the hopes of keeping the surprises at bay!
3:10 Solving Key Protocol Deviations Challenge to Improve Data Quality
Galuchie, Director, Global Clinical Trial Operations, Merck & Co., Inc. & TransCelerate Program Lead
Currently, clinical research sponsors and sites are struggling to interpret certain elements of the ICH E3 and the associated guidelines related to protocol deviations. This difficulty has led to potential reporting delays, questions
related to the classification of “important” and “non-important” deviations, reduced intra-organizational consistency, and a potential overreporting of deviations which could directly impact reliability
of study data, human subject’s protections, patient safety and/or data quality. Based on input from investigational CROs and sites, as well as research sponsors themselves, the TransCelerate Protocol Deviations Initiative
is engaging health authorities to create a Protocol Deviation Management Toolkit to ultimately improve patient safety, reliability of study data, human subjects’ protections and data quality.
3:40 Beyond Risk-Based Monitoring: Employing Risk-Based Management
Rob Bolduc, Director, Product Management, ERT
Discussion highlights include: 1) Exploring process, resource, and technology challenges in implementing risk-based management 2) Overcoming challenges in data source variability and data aggregation 3) Moving beyond risk-management,
into performance management: Incorporating study start-up metrics, milestone tracking, and other KPIs 4) Complying with ICH E6 guidance: Sponsor / CRO roles in risk-based management and oversight 5) Finding the best model and solution
for your organization: Maturing into risk-management, the value of pilots and proofs of concept (POCs)
4:10 Find Your Table and Meet Your Moderator
4:15 Interactive Breakout Discussion Groups
Concurrent breakout discussion groups are interactive, guided discussions hosted by a facilitator or set of co-facilitators to discuss key issues presented earlier in the day’s sessions. Delegates will join a table of interest
and become an active part of the discussion. Bring your pharma, biotech, CRO, site, hospital or patient perspective to each of the discussions. To get the most out of this interactive session and format, please come prepared to
share examples from your work, vet some ideas with your peers, be a part of group interrogation and problem solving, and most importantly, participate in active idea sharing.
5:00 Welcome Reception in the Exhibit Hall (Plaza International Ballroom)
6:30 Close of Day
Day 1 | Day 2 | SCOPE Final Brochure | Quality, Monitoring Brochure
Wednesday, February 20
7:15 am Registration Open (Convention Level)