Arden Biometrics
Accelerate Your Database Lock. Rescue Your Legacy Data.
Arden is an asset-light Biometrics FSP. We deploy elite Clinical SAS programmers into a Zero-Trust AWS cloud to map your Phase 1/2 oncology datasets to 2026 CDISC standards — in half the time of a legacy CRO.
100% 21 CFR Part 11 Compliant
CDISC Gold Standards
Zero-Trust AWS Architecture
Big CROs are bottlenecking your trial pipeline.
You recently acquired a promising asset or finished a Phase 1 trial. But your primary CRO has a 6-month waitlist just to convert your legacy data into FDA-ready SDTM and ADaM formats. You are burning cash waiting on basic data mapping.
The FSP Built for Agility and Total Data Sovereignty.
🛡️ Data Sovereignty: Your data never leaves American jurisdiction. We operate strictly within an encrypted, locked-down AWS VDI.
🧬 Oncology Veterans: No junior coders. We provision ex-Tier 1 CRO talent who have navigated RECIST and complex AE mapping for successful FDA filings.
âś… Double-Programming QC: Every dataset and TLF is independently programmed by two isolated scientists to guarantee 100% mathematical parity.
Specialized Biometric Capabilities
Legacy Data Rescue & SDTM Conversion
We rapidly ingest your fragmented Phase 1/2 raw data and map it into flawlessly compliant, FDA-ready CDISC SDTM standards. Bypass the 6-month CRO waitlist with our secure, accelerated harmonization process.
100% Independent Double-Programmed TLFs
We mitigate your regulatory risk by deploying two isolated scientists to independently program every Table, Listing, and Figure from scratch. This rigorous mathematical parity ensures your safety and efficacy results are completely audit-proof.
ADaM Dataset Generation
Our elite senior programmers translate your complex oncology endpoints—including RECIST criteria and overlapping adverse events—into precise Analysis Data Models. We accelerate your database lock so you can immediately begin analyzing efficacy.
Define.xml & Reviewer's Guides (SDRG/ADRG)
We finalize your submission with machine-readable Define.xml files and highly detailed, transparent Reviewer’s Guides. You receive a perfectly structured, eCTD-ready package designed to sail through FDA technical validation without delays.
Arden Biometrics LLC
1500 Ridgeway, Boston, MA, 02120
Phone : +1 (617)-961-2504
Email : [email protected]
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