Innovative Consulting Solutions for V2 Clinical

Full CDISC-aligned data management services from database build through lock. Lean teams, clean data, and rapid delivery backed by SOPs, QC steps, and therapeutic experience across oncology, CNS, and rare disease. 

Our team delivers EDC builds, edit checks, data review listings, reconciliation, external data integration, and lock preparation with exceptional rigor. V2 supports both full DM outsourcing or targeted FSP-style augmentation for sponsors needing flexible, senior-level support.

Transparent statistical leadership and programming support that accelerates analysis and regulatory readiness. From SAP development to TLF packages and exploratories, our statisticians deliver with speed and precision. 

We support study-level and program-level statistics, interim analyses, DSMB preparation, randomization, sample-size assumptions, and submission-ready statistical outputs. Our programmers deliver reproducible code, CDISC conversions, and validated outputs to ensure clean, timely statistical deliverables.