SecureGen provides a cloud‑hosted, validated Platform as a Service that consolidates regulatory‑compliant data, SAS/R/Python environments and pharmacometrics engines such as NONMEM and MONOLIX into a single, version‑controlled workspace. The platform offers scalable HPC clusters, granular role‑based access, audit‑trail lineage and API integration to meet FDA 21 CFR Part 11 and GxP requirements, enabling pharma and biotech R&D teams to accelerate analysis and submissions.
Funding
Funding not disclosed
Founders
Product
Problem
Pharmaceutical and biotechnology organizations must manage large volumes of regulatory‑compliant data across biostatistics, pharmacometrics, and toxicology workflows, yet many existing tools are fragmented, lack validated cloud environments, and require manual integration, leading to delays in analysis and regulatory submissions.
Solution
SecureGen delivers an enterprise‑grade Platform as a Service that centralizes regulatory‑compliant data, analysis pipelines, and computational resources in a single, cloud‑hosted environment. The platform provides validated SAS, R, Python, and specialized pharmacometrics engines (e.g., NONMEM, MONOLIX) alongside high‑performance HPC clusters that can scale from a few cores to tens of thousands. All data and workflows are version‑controlled with full audit trails and granular role‑based access, ensuring traceability for regulatory review. Integrated APIs enable seamless connection to third‑party tools and enterprise systems, while 24 × 7 support and automated compliance monitoring maintain a validated state without manual overhead. This unified approach reduces time to insight, accelerates drug‑development timelines, and supports secure collaboration across distributed R&D teams.
Target Audience
Primary customers are R&D, biostatistics, clinical pharmacology, and pharmacometrics teams within large pharmaceutical companies and mid‑size biotech firms that require validated, cloud‑native analytics and secure data management.
Features
- Cloud‑hosted, validated SAS and R environments with pre‑qualified packages for regulatory use
- Integrated pharmacometrics engines (NONMEM, MONOLIX, PSN, MPI, PIRANA) and R/RStudio within the same platform
- Scalable HPC “Sonic Cluster” that auto‑provisions compute resources from small clusters to tens of thousands of cores
- Version‑controlled data repository with immutable audit logs, granular RBAC, and full lineage tracking
- API‑driven integration layer for enterprise systems, third‑party analytics tools, and data exchange
- End‑to‑end encryption and continuous compliance monitoring to meet FDA 21 CFR Part 11 and GxP standards
- 24 × 7 technical support and managed services, including automated software updates and validation documentation