N-SIDE-Suite-Clinical-Trials

The Challenge

Handle uncertain demands in clinical production planning

When planning the production of medicine required for clinical trials, many factors are subject to change, such as timelines, projected demands, shelf-lives, manufacturing resource availabilities and priorities. There are also multiple stakeholders involved, each with their own tools, and often without a standardized planning process.

Creating a drug production plan to cover this uncertainty and manage the associated risk, without jeopardizing trial timelines and while also minimizing costs, can be a difficult challenge for production planning teams.

The Solution

Evaluate, Plan and Optimize Clinical Trial Production

Reacting to change is essential in clinical supply management. N-SIDE Production App optimizes your production planning while managing the risk including the demand uncertainty provided by N-SIDE Supply App. Accurately model your manufacturing process and evaluate the many variables with easy what-if analysis, to produce an optimized production plan with lot-to-lot allocation, lot-to-study allocation and up/down traceability.

N-Side Production App introduces standard processes to ease collaboration and knowledge transfer. Updates to changes are faster and more reliable as they are performed automatically with the input of the changed parameter.

The Production App and Supply App are integrated solutions providing end-to-end clinical supply chain optimization.

Evaluate

Manage the risk of the unexpected
Evaluate the impacts of manufacturing at different facilities, taking into account costs, yield, capacity, shipping and timelines. Manage the risks, such as changes to the stability plan, delays in releases and additional trials, by testing what-if scenarios and creating contingency plans.

Plan
Create an informed plan considering all variables and constraints
Model your specific manufacturing process from drug substance to investigational product and any intermediate steps. Consider all possible variables and your specific constraints and create a reliable production plan which mitigates risk, improves timelines and minimizes waste and costs.
 
Optimize

Decrease waste and manufacturing costs with optimal compound planning
Optimize your compound production planning respecting all of your clinical trial specific constraints, such as shelf-life extensions, lot sizes, and lot-to-lot allocation constraints. Batches can be allocated so that trials receive optimal batch release dates and quantities, considering shipping and storage requirements, to reduce waste and satisfy demands with sufficient remaining shelf-life for all trials.

 

N-SIDE Production App integrates with your inventory management system / ERP in order to collect up-to-date information about the project (including study information, non-clinical needs, existing production batches and current inventory) and implement the optimal production plan for the compound.

N-SIDE Production App also integrates with N-SIDE Supply App to ensure any changes in production inform supply decisions and vice versa. This creates a fully integrated end-to-end clinical trial supply chain management system and allows for globally aligned decision making.

Production planning

ensure production meets uncertain demand and varying timelines by considering all constraints. Optimize your planning from drug substance production through to investigational product, with lot allocation to trials, to minimize waste.

Budget planning

evaluate the impact of different manufacturing decisions on your budget regarding fixed and variable costs. Know the production cost breakdown per trial.

Risk Management

assess different what-if scenarios and ensure your planning will cover the risk including the demand uncertainty as measured by N-SIDE Supply App.

The Results

Optimized, integrated clinical trial production plan

No matter the size of your organization, N-SIDE Production App provides a fully integrated production planning application which gives you confidence in meeting uncertain demands and fluctuating timescales.

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Optimal batch release dates and quantities

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Plan for uncertainty and mitigate risks

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Ensure production meets trial dosing demand and timings

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Batch allocation to trials with upwards and downwards traceability

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Production cost breakdown per trial

Benefit from end-to-end integration, discover the N-SIDE Suite for clinical trials and its other applications!

N-SIDE supply APP

Optimize your strategic IP forecasting, future-proof your design & planning, efficiently manage your risk

N-SIDE dashboard APP

Visualize and intuitively interact with your clinical data for efficient study monitoring & reporting.

We are committed to respecting your privacy and protecting your personal data, including any information which allows us to identify you as an individual person. N-SIDE uses the personal data in a fair and lawful manner. N-SIDE collects and processes personal data in accordance with the privacy statement available in the privacy policy.
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