AlphaLife Sciences Joins CDISC as Gold Member: Elevating AI-Driven Regulatory & Medical Authoring
May 07, 2025
AlphaLife Sciences is now a Gold Member of CDISC—a strategic milestone that amplifies the value of our AI-powered AuroraPrime Regulatory & Medical Authoring Platform for enterprises.
Why This Matters for Your Business:
CDISC’s global data standards (SEND, SDTM, ADaM, etc.) are critical for regulatory compliance. By integrating these standards directly into AuroraPrime, we enable:
Seamless Compliance: Auto-generate CDISC-aligned clinical trial documents, reducing manual errors and accelerating FDA/EMA submissions.
Faster Authoring: Transform raw data into submission-ready reports using AI trained on CDISC frameworks, cutting timelines by up to 50%.
End-to-End Traceability: Ensure audit-ready workflows from data collection to regulatory filing, powered by CDISC’s universal standards.
Accelerating Digital Data Flow with AIOur collaboration with CDISC and TransCelerate on the Digital Data Flow initiative supercharges AuroraPrime’s ability to:
Automate protocol-to-submission workflows, replacing document-centric processes with dynamic, data-driven authoring.
Enhance cross-stakeholder alignment with standardized data inputs, reducing rework for sponsors and CROs.
Partner with AlphaLife As a CDISC Gold Member, we’re positioned to shape the future of clinical data standards—ensuring AuroraPrime remains the most advanced, compliance-driven platform for enterprises. Backed by Microsoft, NVIDIA, and Veeva, we empower top pharma companies to:
✔️ Slash medical writing costs
✔️ Eliminate compliance risks
✔️ Accelerate drug approvals
