CONFERENCE PRESENTATION · SCDM 2021 Global Conference
Expect the Unexpected - Are Innovations hiding in Plain Site
- Session Type: Oral Presentation
- Session Level: Intermediate
Overview
In this session you should expect to hear from SMEs across the industry about the application of Risk Based Data Management and AI/ML with a focus on the processes and people. You will hear from those that have experimented and have been successful as well as those that have experimented and failed to better understand where others are taking chances and learning and how they are translating these learnings into new processes and skills for the CDMs. How can we develop processes and people to be more effective in support of Risk Based approached to the execution of data management in clinical trials. Understanding what has come before, what is happening now and what is possible to come is important for all CDM organizations in the future. In this session variety will also be something you are exposed to. How are sponsor companies approaching this area, vendors, CROs and/or academic sites and most importantly how can we work together to all improve DM in clinical trials for better, more cost effective outcomes for patients around the globe.
What You'll Learn
- Attendees will learn how several leading Pharma and CROs are considering process implications to support RBDM/RBQM both in conjunction and independent of RBDM/RBQM technology.
- Attendees will learn from several leading Pharma and CROs considerations related to upskilling and change management for people (CDMs/CDSs) when implementing RBDM/RBQM both related to and independent of technology change.
- Attendees will hear the practical challenges, along with mitigations and solutions for these, related to process and people, when companies are attempting to implement RBDM/RBQM strategies in their DM departments.
- Attendees will be able to understand some of the successes and failures related to implementation of RBDM/RBQM related to the surrounding processes and the people.
Meet the Presenters
Maria Craze
Executive Director, Clinical Data Management
Merck & Co., Inc.
Merck & Co., Inc.
Sara Cummings
Oncology Program Lead
AbbVie
I am a Program Lead with AbbVie. I have worked in numerous therapeutic areas, including Neuroscience and Pain, with the majority of my time spent in the Oncology program. I have been with AbbVie for 30 years, performing a variety of roles within the Clinical Data Strategy and Operations Organization.
AbbVie
Vidya Deo
Director
AbbVie
AbbVie
Po Nam Loo
Director, Clinical Data Management
MSD
• Over 20 years of clinical data management and medical coding experience in paper and EDC, covering global Phase 1 to 4 clinical trials in various therapeutic areas.
MSD
• Establish, supervise and lead a Data Management organization in China that is accountable and responsible for translation of protocols and other requirements into data collector and other data management tools for late development (LSD) trials to deliver clean, reliable, credible, reproducible data for proving the efficacy and safety of clinical products in development that enable rapid clinical development decision-making and the advancement of company’s pipelines.
• SCDM Certified Clinical Data Manager (CCDM) since 2015 and has served as a speaker at the past SCDM China and DIA China annual conferences and/ or seminars.
• Global SCDM volunteer experience in CCDM Technical Review Team-Volunteer.
Paulina Szczepaniak
Operations Lead
MSD Switzerland
Paulina Szczepaniak, MPharm and Director of Operations at MSD, started her career in 2015 and progressed through multiple roles with increasing levels of responsibility and technical expertise in various Therapeutic Areas (TAs). Paulina is ensuring quality in DM processes as Subject Matter Expert (SME) in clinical trial data validation, looking into future strategies, as well as acting as a change agent for the adoption and implementation of new technologies and ways of working, following Industry standards and ensuring the best possible results for the end users.
MSD Switzerland
Sabrina Steffen
Sr. Director, Innovation & Data Strategy Data Sciences, Safety and Medical
IQVIA
Sabrina Steffen is the Head of Data Strategy and Innovation for Data Management, Biostatistics Connected Devices, Medical Safety Services and Lifecycle Safety. She is US-based and has worked in clinical research for 18 years, within data management, risk-based monitoring, data strategy, process improvement and innovation. Sabrina has led the Data Strategy and Innovation team for 8 years overseeing large scale process and technology transformations starting from inception, through delivery and change management to achieve fully embedded technology-enabled processes.
IQVIA
Rhona O'Donnell
Sr. Director, Data Management
ICON
Rhona O’Donnell, Senior Director, Data Management has over 18 years’ experience in Data Management where she has held various leadership roles across ICON Data Management. Rhona is currently the Head of Data Management for Europe at ICON with ultimate responsibility for DM project delivery in the region. In addition, Rhona oversees the Global Clinical Programming Group across Data Management. Rhona is very well-versed in DM technologies and is particularly experienced in technical system selection and comparison as well as technical transition projects. Rhona has extensive experience in change control and process improvement projects with ICON and also supports clients for these activities. Rhona also leads the Clinical Risk Management (CRM) development team overseeing CRM Tool development and implementation.
ICON
Earn CEUs
SCDM is authorized by IACET to offer 0.1 CEUs for this education program. Participants are eligible to receive CEUs upon successful completion of the digital assessment questionnaire linked to this session, within 30 days after the purchase of the conference session.
Price
SCDM members: $50
Non-members: $175
Not yet an SCDM member? Purchase this conference session and get a one-year membership with SCDM on us to enjoy all our educational programs and sessions at a discounted price.
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