CONFERENCE PRESENTATION · SCDM 2024 EMEA Leadership Forum & Conference
Impact of Data Standard Requirements on DM Practices
- Session Type: Oral Presentation
- Topic: Regulations & Standards
- Session Level: Intermediate
Overview
The complexities facing clinical trials are vast when you consider the broadening of clinical trial data sources and rigorous data standard (e.g. CDISC) requirements that continually evolve. The lifecycle of data starts with data management in its raw collected form but must also be converted into standard datasets (e.g. SDTM and ADaM) for an increasing number of regulatory agencies. Data management practices from CRF design, reconciliation, and cleaning can streamline downstream data efforts or negatively impact the next data customer. This session will delve into data standards practices and how data management is at the forefront of streamlining practices to support data standard deliverables. By the end of this session, Data Management personnel will gain a clearer understanding of the rationale behind specific requests made by your statistical and programming teams during the design and collection phase of your clinical trial; why pushing data standards earlier in the data lifecycle can offer substantial cost and timeline savings; and how multiple functional areas need to work together to implement successful data standard practices.
What You'll Learn
- After this session, attendees should understand why CRFs should be designed with downstream data standards in mind.
- After this session, attendees should have examples of where data management can work with other functional areas to support data standards.
- After this session, attendees should recognize what data issues can potentially cause a problem in data standards compliance within SDTM.
Meet the Presenters
Heather Kopetskie
Senior Director, Biostatistics
Rho
Heather Kopetskie, Senior Director of Biostatistics, has worked at Rho for more than 19 years. Ms. Kopetskie provides leadership and oversight for the biostatistics department and utilizes her experience to guide sponsors on the design and analysis of clinical trials. Her experience spans many therapeutic areas with an emphasis on solid organ and cell transplantation along with rare disease (orphan) products.At Rho, she has supported both federally funded projects and biotech/pharmaceutical companies. During her tenure she has served as the biostatistical functional lead for the Immune Tolerance Network (ITN) Statistical and Data Coordinating Center and the Clinical Trials in Organ Transplantation (CTOT) Statistical and Clinical Coordinating Center overseeing more than 30 studies in the areas of allergy, immunology, and transplantation. Ms. Kopetskie earned her master’s degree in Biostatistics from UNC-Chapel Hill.
Rho
Tamas Tukszar
Senior Statistical Programmer
Rho
Tamas is a Certified SDTM expert and Clinical Trials SAS Programmer with a decade of pharmaceutical industry experience. His background spans across Data Management and Biostatistics, giving him a strong understanding of clinical data flow.
Rho
Matthieu Chaton
Team Lead of Data Quality
UCB
Graduated with a MsC in Systems and Innovation, I have 13+ years of experience in the clinical trials as a Clinical Data Analyst and SDTM expert. I have collaborated on multiple international studies for top tier pharmaceutical sponsors, and been leading innovative projects related to data collection and integration. I have a solid experience with ePRO/eCOA and EDC systems. I have joined UCB in July 2022 and I’m now Team Lead of Data Quality, being focused on CRF builds and SDTM mapping.
UCB
Jennifer Manzi
Product Success Manager
Certara
Jennifer Manzi is a Subject Matter Expert and User Advocate at Pinnacle 21. She has over 20 years of Pharma/Life Sciences industry experience in Clinical Trials and Safety Data Management. Jen has held various roles within these areas, including eCRF Programmer, SDTM Delivery Lead, Product Owner and Programmer of Batch Processes, Vendor Relationship Manager, Program and Process Improvement Manager, and Validation Lead.
Certara
Gilbert Hunter
Customer Success Manager
Certara
Gilbert joined Formedix over eight years ago as a technical writer. The knowledge he gained from content development, together with his customer service skills marked him out for transition to the Professional Services Team. Gilbert worked in this role for over 3 years, providing both CDISC and software training, as well as support and consultancy services to Pharmaceutical, Biotechnology and CRO organizations. He helped them save time and improve quality by making their clinical trial design and regulatory submissions far more efficient. Today, as Customer Success Manager, Gilbert’s focus is to ensure customers overcome their challenges, achieve their goals, and ultimately maximize the benefits they can achieve from our ryze software.
Certara
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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