Clinical Trial Planning

The foundation of any Life Sciences clinical trial is the trial pharmaceutical or device, managing and forecasting inventory levels and costs by product, lot, dosage and expiry date to ensure sufficient inventory, access to that inventory and access to the limited, high cost manufacturing resources and facilities is a critical, complex process.

The timing and levels of drug depletion depend on a variety of variables including Patient Volumes & Timing, Patient Indication and Patient specific factors such as Height & Weight which all drive Patient Specific Dosage requirements and Depletion.

Blue Line’s cloud based Life Sciences Inventory Management System, allows Life Sciences Companies from Pharmaceutical to Biotech to Medical Device to efficiently manage and understand inventory levels and costs, and effectively manage high cost manufacturing processes over the life-cycle of the trial which typically lasts years.

The patient intake planning module allows users to plan, over the life-cycle of the trial patient enrollment, physician enrollment sites, dosage levels by indication, timing of patient dosages and active / Placebo ratios.

Blue Line’s “Life Sciences Inventory Waterfall” module allows organizations to understand inventory levels by Time Period including; Beginning Balances, Depletion and Ending Balance by Product, Lot, Dosage and expiry date.

The cost accounting module costs inventory value at each step in the “Inventory Water- fall” to support and apply standard and company configurable accounting guidelines to accurately cost inventory.

The Inventory Operations module forecasts when additional Product, Lot and Dosages will be required to replenish inventory levels. Typically organizations require 12 – 16 month lead time to schedule, plan and prepare manufacturing facilities to produce clini- cal trial drugs.