Optimize end-to-end production planning from DS to IMP.
The N-SIDE Production App gives you unprecedented flexibility to optimize manufacturing for your clinical projects, from drug substance (DS) to drug product (DP) to investigational medicinal product (IMP).
Use the Production App to build and maintain an optimal clinical production plan that accounts for your specific constraints. Respond quickly and efficiently to unexpected changes with what-if scenarios.
The Production App enables data-driven decision making and enhanced communication between teams for each project in your portfolio.
More than a software product, the Production App is supported by expert services from the leading minds in clinical supply chain optimization.
How it works
A more strategic, proactive approach to production planning
Design
Plan
Adapt
Design
1The N-SIDE Production App optimizes strategic design decisions regarding clinical manufacturing, like:
- Outsourcing vs. in-house manufacturing
- Network design
- Vendor selection
- Lot sizing
- Stability strategy
- Lot-to-lot allocation constraints
The Production App identifies the main levers for maximizing manufacturing efficiency, including DS, DP, and allocation to trials.
The Production App also supports the evolution of your manufacturing design, including scale up strategy optimization and transition to commercial manufacturing.
The Production App incorporates key R&D production variables and criteria, including:
- Stability plans and related expiry date extensions
- Regulatory constraints
- Clinical, technical, and commercial needs
- Bill of Materials (production yields)
- Production capacity constraints
- Costs
- Current inventories
- Ongoing production runs
- Lead times
Plan
2Using the latest IMP demand from the N-SIDE Supply App or any other source, the Production App optimizes production planning at the clinical project level. Achieve a plan with optimal:
- Quantities and timing
- Production, storage, and distribution timelines
- Downstream lot allocation
- Allocation to clinical trials
The Production App also supports non-clinical demands (e.g. commercial, sampling, stability) and all products required for conducting clinical trials (e.g. ancillaries, safety medications, comparators).
Using the Production App, drugs are allocated according to demand, unallocated lots are redistributed, rational and transparent safety buffers are built-in, and waste is reduced — all while protecting your clinical supply chain against shortages.
Adapt
3The N-SIDE Production App can be integrated into the sponsor IT landscape to increase efficiency and deliver a production plan that always remains grounded in reality.
Re-optimize your clinical production plan to adapt to events like:
- New trials
- Protocol amendments
- Updated recruitment timelines
- Unexpected events
- Batch delays and losses
- Process updates
- Network updates
The Production App will always provide a solution to keep risks under control, keep your waste down, and keep stakeholders informed.
Benefits
Develop a clinical manufacturing plan that’s both tailor-made to current conditions and always up to date. With the Production App, you can account for all constraints of each project on an ongoing basis, while minimizing waste and keeping your budget under control.
The advanced modeling capabilities of the Production App let you proactively test changes to clinical operations based on reliable and accurate data, so you can adapt quickly to whatever situations arise.
Users of the Production App are ready to answer any stakeholder question with reliable, accurate, up-to-date results. Improve collaboration and enhance accountability with better visibility.
Outcomes
-
10-20% waste reduction at manufacturing -
100% trial demand satisfaction -
Increased agility -
2-6 months reduction in time to market -
Budget reduction