In the past two decades, regulators have placed increasing emphasis on submitting standardized data. In an age where investments in clinical development continue to climb, it is important to understand how an effective data standards strategy can help biopharma companies improve efficiencies, to maximize returns on the R&D investment.
The adoption of data standards for small to mid-sized biotech companies is lower due to much smaller and product-focused portfolios, where investing in implementing, building and maintaining libraries can be a costly affair. Although, the absence of data standardization typically hits companies at the end of the development journey, when clinical data has been handled by various CRO and technology partners, thus making managing, cleaning and analysis during submission stressful and resource intensive.
There is no one size fits all solution, but there is a solution for everyone. The key to success lies in aligning to long-term goals and implementing standardization in phases.
Register for this webinar to learn how a proactive data standards strategy can be crafted and effectively implemented, thus ensuring submission readiness while optimizing resources. Once standards are implemented, the options for automation are almost limitless, thus building efficiency and quality into processes.
Speakers
Jason Housely, Head, Global Clinical Data Standards and Automation, Novartis
Jason Housley is currently Head of Global Clinical Data Standards & Automation at Novartis. In this role, he is responsible for creating and executing Novartis’ metadata-centric standards vision, globally, across all areas of data operations. With 27+ years in the industry, Jason has held positions within AstraZeneca, Covance, Shire, Eli Lilly, TEAMworks, Glaxo, GlaxoWellcome and GlaxoSmithKline. Over this time, Jason has headed several business functions including standards, system owner groups, EDC build/clinical programming, business infrastructure and data management.
Externally, Jason has served as the CDISC SHARE SDTM content co-lead, held positions on the CDISC Advisory Board (CAB) and as CAB strategic lead (2012), served on the CDISC European Coordinating Committee (E3C) (Mar 2009 – Sept 2012), Co-lead CDISCs Terminology Governance and Implementation sub-team (May 2009 – May 2011) and Co-lead of CDISCs English Speaking User Network (Feb 2008 – Dec 2010) and remains a trusted advocate. Jason has a B.Sc. (Hons) in Applied Biology from Coventry University.
Message Presenter
Nithiya Ananthakrishnan, Founder and CEO, Algorics Inc.
Nithiya is a passionate life science professional with over 18 years of dedicated clinical research industry experience in the areas of clinical technologies & data science.
He is currently CEO of Algorics, a fast-growing, clinical data science company focused on data management, biostatistics, data standardization, risk-based quality management and advanced data analytics.
Prior to Algorics, Nithiya was associated with ICON clinical research and Cognizant technology solutions in various management roles including leading large, diverse cross-functional groups in clinical technologies and statistical programming.
He is a proud recipient of PharmaVOICE 100 award in 2017 and a recognized industry thought leader associated and presenting in various industry associations and forums (SCOPE, CBI-RBM, Arena, eClinical forum, PhUSE, IASCT, DIA) in the field of clinical data value chain, SAS programming, risk-based monitoring and machine learning.
Message PresenterWho Should Attend?
CXOs, department heads, directors, managers and project leads across the following functions:
- Biometrics
- Statistical Programming
- Biostatistics
- Data Standards
- Clinical Data Management
- Automation
- Digital innovation and strategy
- Data Science
- IT
- Clinical innovation
What You Will Learn
Attendees will learn about:
- Planning and executing the effective implementation of data standard libraries
- Leveraging data standardization to maximize returns on R&D investment
- Automating with data standards to build efficiency and quality
- Ensuring compliance and submission readiness
Xtalks Partner
Algorics Inc.
Founded in 2013, Algorics is a specialized data solutions partner to the life sciences industry focusing on data management, biostatistics, statistical programming, and data standardization. Driven by our next-generation technology suite – MetaVate which enables data standards automation and Clarity, a solution tailored for central clinical data monitoring and intelligence, we help our global portfolio of biopharmaceutical and CRO clients increase productivity and accelerate development. This is augmented by an innovative solutions platform – IDEAS and a highly experienced team across US, Europe and Asia, to provide end-to-end, cost-effective, and high-quality analytical services.
Digital transformation, data and statistical solutions, early evidence detection and audit intelligence is at the core of our expertise. We believe healthy partnerships are key to success in life sciences research and we walk with our clients every step of the way, helping bring path-breaking treatments to market every single day.
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