Clinical Supply Consulting
Strategy. Planning. Execution.
Helping our clients drive their innovative products from manufacturing to the patient.
YPrime Clinical Supply Consulting and IRT
Life science companies spend their time and resources on developing innovative products and treatments to improve the lives of patients. With their focus on the scientific rigors of product development, they may require extra resources to effectively manage all or part of their clinical supply chain lifecycle.
With more than 25 years of experience, YPrime’s clinical supply consulting team has the depth and breadth of industry expertise and experience to help life science companies drive their innovative products from manufacturing to the patient. With our ability to view projects from a macro level and offer consolidated services, we can create better efficiencies for clients, maximizing your investment while reducing your stress.
The clinical supply consulting team’s experience spans:
- Clients across the globe
- Multiple therapeutic areas, at various levels of complexity
- All the major packaging and labeling, courier, and interactive response technology (IRT) vendors
Clinical Supply Consulting Services
Vendor Management
Help sponsors select packaging and labeling (P&L), courier, and interactive response technology (IRT) vendors. Recommendations are made objectively, based on the sponsor’s specific needs and our experience.
Get Drug Product from the Manufacturer to the P&L Vendor
Work with the manufacturer to get drug product shipped to the P&L vendor, track shipments, confirm shipment conditions, and confirm receipt of shipments.
Label Text Generation and Label Generation
Generate Master English Label Text (MELT) for Clinical Trial Material (CTM) and work with the P&L vendor to have CTM labels generated for the production runs.
P&L Vendor Activities
Schedule production runs and assist with pre/post batch record reviews or work with the sponsor QA to have the documents reviewed and approved. Work to have the appropriate depots set up, schedule depot transfers or site shipments, and if an IRT system is used, load CTM into the IRT.
IRT Maintenance/User Acceptance Testing (UAT)
Act as the unblinded clinical supply role in the IRT– load CTM for the study, release CTM lots, set up resupply strategies, create shipments, and release quarantined CTM from temperature excursions. Perform end-to-end UAT or clinical supplies UAT in IRT systems.
Clinical Supply Forecasting
Perform pre-study forecasting to determine how much drug will be needed for the study based on the number of sites, countries, depots and how much DP is available. Provide ongoing study forecasting services and monthly updates.
Temperature Excursion Management
Act as the first level of review for temperature excursions. Document, approve, assess temperature excursions, and monitor site inventory and patient dosing.
SOP Development
Review sponsor SOPs or develop new SOPs as needed, for temperature excursion management, label text generation, processing and handling of CTM, returns, destruction, and accountability.
Comparator Sourcing
Assist with sourcing comparators for clinical trial use or research testing, work with various vendors to acquire quotes, set up comparator sourcing vendors, and assist with shipping of material.