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, d-wise, an Instem Company
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, d-wise, an Instem Company
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
d-wise, an Instem company
With over 25 years of experience, d-wise, an Instem company, is a global leader in clinical analytics and transparency. Instem, a global SaaS leader and scientific services provider, helps our clients discover, accelerate, and advance key R&D programs through science-powered solutions and best-in-class research practices.
Our industry-leading cloud-based statistical computing environments (SCEs), Accel™ and Aspire™, accelerate clinical results and enable faster, more efficient therapy development. With built-in regulatory safeguards, clinical research teams can ensure they’re staying compliant. Our one-of-a-kind anonymization software, Blur™, is designed for clinical data de-identification, anonymization, and risk assessment. By leveraging NLP and a robust risk assessment engine, Blur™ ensures risk-free data sharing, enabling sponsors to meet regulatory requirements with confidence. Our consulting and strategic support services provide alternative solutions for clients facing unique challenges.
d-wise and Instem support the entire R&D lifecycle with a customer-obsessed mindset, ensuring clients feel confident regardless of the pain point.
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