Providing specialized Clinical Data Management, Statistical Programming, and AI-driven automation for Biotech and Pharma.
Founded in October 2024, ASAAJ LLC was created with a singular vision: to bring uncompromising precision and innovation to clinical data management and statistical programming for the Biotech and Pharma industry.
Our approach is built on three pillars that set us apart—deep Services expertise, a library of Standardized Templates ensuring compliance and efficiency, and forward-looking AI Innovation that transforms how clinical data is managed.
We partner with sponsors, CROs, and biotech organizations to deliver regulatory-grade deliverables that accelerate clinical development timelines.
End-to-end CDM and Statistical Programming support with deep regulatory expertise.
GxP-compliant document library—DMPs, SAPs, validation logs—ready to deploy.
Intelligent automation tools redefining vendor reconciliation and UAT processes.
With extensive experience spanning clinical data management and statistical programming across multiple therapeutic areas, our founder established ASAAJ LLC to bridge the gap between traditional clinical data services and next-generation AI-powered automation.
Their deep understanding of regulatory requirements—from CDISC standards to 21 CFR Part 11 compliance—combined with a passion for technological innovation, drives the company's commitment to delivering precision and excellence.
From database design to regulatory submission, we deliver end-to-end support with uncompromising quality.
Expert setup of Medidata Rave, Veeva Vault CDMS, Oracle Clinical, and other EDC platforms.
CDISC-compliant CRF design mapped to SDTM domains from day one.
Systematic edit check programming, discrepancy management, and medical coding.
Vendor data integration, lab data reconciliation, and SAE/CIOMS reconciliation.
Ensuring data integrity through rigorous lock procedures and 21 CFR Part 11 compliant archival.
Standards-compliant dataset development using SAS and R, with full traceability.
Tables, Listings, and Figures for CSRs, ISS/ISE, and regulatory submissions.
Submission-ready metadata documentation meeting FDA and PMDA requirements.
Independent double programming and validation per PHUSE best practices.
Pinnacle 21 validation, P21 issue resolution, and OpenCDISC compliance.
Our R&D arm develops intelligent tools that automate complex, error-prone processes in clinical data management.
Our intelligent reconciliation engine automates the comparison of vendor datasets against EDC data, identifying discrepancies with unprecedented speed and accuracy. Coupled with automated UAT capabilities, it dramatically reduces manual effort while improving data integrity.
Our standardized, GxP-compliant template library ensures every deliverable meets the highest regulatory standards.
Comprehensive DMPs covering data flow, edit check strategies, reconciliation processes, and lock criteria.
Detailed SAPs with pre-specified analysis methods, table shells, and endpoint definitions.
Complete validation documentation—IQ/OQ/PQ, UAT scripts, traceability matrices, and test evidence.
All processes and systems designed for full compliance with electronic records and signatures requirements.
Adherence to international regulatory guidelines ensuring global submission readiness.
SDTM, ADaM, and controlled terminology implementation verified through Pinnacle 21 validation.
At ASAAJ LLC, we're building a team of exceptional Clinical Data Managers and Statistical Programmers who thrive on solving complex problems in clinical research.
We offer the opportunity to work on cutting-edge biotech trials, access to modern tools and AI-driven workflows, and a culture that prioritizes technical excellence and professional development.
We invest in your growth through mentorship, training, and exposure to diverse therapeutic areas.
Be at the forefront of AI and automation in clinical data—contribute to tools that reshape the industry.
Every dataset you manage and every program you write contributes directly to bringing therapies to patients.
Whether you need CDM support, statistical programming, staffing, or want to learn about our AI tools—we're here to help.
Prefer to speak directly? Book a 30-minute consultation to discuss your clinical data needs.
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