Immix prepares clinical-to-commercial distribution with a serialized, audit-ready system of record
Customer
Immix Bio, an emerging biotech organization coordinating clinical operations and commercialization planning across multiple partners—including CDMOs in the U.S. and Canada—and a network of clinical sites across the U.S.
The challenge
Immix needed to connect clinical and commercial supply chain realities into a single operational picture—without relying on spreadsheets and manual reconciliation.
Operationally, the program involved: – Multiple CDMO handoffs (including cross-border coordination) – A distributed clinical footprint (approximately 21 clinical sites across ~15 states) – Commercialization readiness requirements (serialization, labeling, DSCSA compliance, and clinic interactions) – Time-sensitive logistics (including references to a 48-hour shelf life scenario in onboarding discussions)
The team needed a way to maintain end-to-end traceability and audit-ready documentation while keeping day-to-day execution practical—especially as timelines and regulatory milestones approached.
Why RxERP
RxERP was selected because it provides pharma-grade ERP capabilities designed for environments where traceability and compliance are built into daily operations: – Serialized inventory + traceability: Designed for pharmaceutical workflows where serialization and traceability are first-class requirements – Audit-ready controls: Role-based access, controlled changes, and defensible event history – Partner coordination: Clear handoff points and workflows across CDMOs and downstream execution partners – Operational efficiency: Reduce manual reconciliation and exception “fire drills” by keeping inventory, movements, and reporting aligned – Financial readiness: Integration patterns that support QuickBooks-style workflows
The solution
RxERP became the foundation for Immix’s onboarding and operational alignment—helping define the “chalk line” between Immix-owned workflows and CDMO-owned workflows, and then standardizing how inventory, movements, and exceptions are captured.
Instead of stitching together multiple tools for inventory, compliance documentation, and partner coordination, Immix could move toward a single system of record that supports: – Clinical and commercial distribution planning – Chain-of-custody visibility across partners – Exception handling and investigation documentation – Audit-ready reporting and evidence packs
Impact (high level)
- Improved readiness to scale from clinical operations into commercialization with standardized, traceable workflows
- Stronger chain-of-custody visibility across CDMOs, shipping providers, and sites
- Reduced operational ambiguity by defining partner handoffs and exception ownership early
Why this matters (for biotech / advanced therapies)
When clinical-to-commercial supply chains involve multiple partners, sites, and regulated handoffs, traceability can’t be an afterthought. RxERP helps teams run pharma-grade operations with serialized, audit-ready controls—without building a large administrative layer to keep systems in sync.
