Life sciences companies face increasing pressure to expand clinical analytics beyond traditional SAS workflows to support more flexible analyses, richer visualizations and faster access to evolving statistical methods. Using open-source languages such as R alongside the commercial SAS language provides access to distinct capabilities and methodologies enabled by the rapid evolution of open-source technology. This webinar will explore how to adopt R alongside SAS while maintaining the validation controls required for compliant clinical use.
With frequent changes and the ability for anyone to contribute, open-source languages rapidly evolve. However, these also introduce significant challenges for validation, a critical component of any technology used for the development and analysis of clinical data.
In this webinar, the featured speakers will outline a practical approach to validating R as an open-source technology. With this approach, attendees will be able to balance rapid adoption of evolving open-source technologies with appropriate controls to ensure that analytic outputs are valid and compliant for clinical use.
Register for this webinar to learn how clinical analytics can be validated when R and SAS are used together for compliant clinical data analysis.
Speakers
Phil Loucks, Commercial Director, Instem Clinical
Phil Loucks has nearly a decade of experience helping life science organizations evolve their statistical computing environments (SCE). He currently leads a team that delivers best-in-class, enterprise-ready SCE solutions, combining technical rigor with a strong commitment to client success.
Message Presenter
Jonathon Hollahan, Deputy General Manager, Instem Clinical
Jonathon Hollahan has an engineering background and began his career in the technology industry designing FDA-regulated laser products, where he led US and EU compliance efforts. He later transitioned to the Life Sciences industry at Strong Tower Solutions, where he managed teams delivering clinical data analytics consulting, implementation services and ongoing SCE support. Following Strong Tower’s acquisition by Instem, Jonathon joined Instem and moved into a management role within the company’s Clinical group.
Message PresenterWho Should Attend?
This webinar will appeal to industry professionals in pharmaceutical manufacturing, biotech research, research services and contract research organizations (CROs), particularly Managers, Directors and VPs in:
- Biostatistics
- Biometrics
- Clinical Data
- IT Services
- IT
- IT Compliance
- Statistical Programming
- Clinical Compliance
- Clinical Data Services
- Clinical Data Management
- Clinical Data Operations
What You Will Learn
Attendees will gain insight into:
- How to validate R for clinical use while maintaining appropriate controls
- How R and SAS can be used together without undermining auditability and traceability
- Practical governance steps to manage package updates, versioning and reproducibility
- How validation practices support compliant clinical analytics outputs
Xtalks Partner
Instem
A global provider of leading software solutions and scientific services, Instem is helping our customers discover, accelerate, and advance key R&D programs by offering solutions powered by science and best practices in research.
We enable organizations in the life sciences to more efficiently collect, report and submit high quality regulatory data, while offering them the unique ability to generate new knowledge through the extraction and harmonization of actionable scientific information.
Across the entire drug development value chain, every day Instem solutions are meeting the rapidly expanding needs of life science organizations for data-driven decision making, leading to safer, more effective products. Founded in the United Kingdom in 1969, Instem has deep roots internationally across North America, EMEA and APAC. We maintain a commercial and technical presence throughout these regions and pride ourselves on localized support for our diverse client base.
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