Inside YPrime with Clinical Supplies Consulting at YPrime
From forecasting, drug logistics, drug sourcing, to overseeing packaging & labeling vendors, planning and managing clinical trial supplies is no easy task. However, it’s an important one for sponsors to consider carefully because the right strategy can help save a lot of money and ensure a study stays on track.
The role of clinical supplies consulting in YPrime’s portfolio.
Clinical trial supply chain management starts with forecasting inventory levels that will be needed throughout the study. It also involves developing plans and strategies for clinical manufacturing, labeling and packaging, storage, distribution, site management and drug reconciliation and destruction. But what about all the moving parts we don’t always consider?
At YPrime, Clinical Supplies Consulting help can begin with protocol review to create a realistic forecast. We can conduct feasibility, develop execution strategies, assist with IRT set-up, and then monitor IRT settings at regular intervals to adjust for actual enrollment patterns. We can also help with questions like ‘what depots should I use to store my study drug’ or ‘how should I build the IRT’?
Our expert team also adds value to our clients by interrupting the data in the IRT to ensure the drug supply doesn’t run out or forget about an upcoming expiry. We know that sponsor-based clinical supply managers are often over-tasked with managing 20-30 studies and routine study-level data reviews can easily be overlooked due to time constraints.
A sponsor may also need help with simple tasks such as updating resupply strategies or tracking shipments, or they may need someone to help with the workload during peak times. A lot of clinical work tends to be cyclical in terms of volume, offering a flexible, a la carte approach to clinical supply expertise sets YPrime apart from other vendors.
Our number one goal at YPrime is to make sure the study drug is at the sites when it needs to be. Our experts plan ahead and for as many contingencies as possible.
Contact us today to see how we can help with your clinical supplies strategy.