One of the biggest challenges for the life sciences industry is to ensure efficiency and control both through the supply chain and across the complex operational landscape—all while complying with regulations. Calculating the clinical supply-demand, optimizing the production, and managing the logistical requirements of moving clinical products are crucial aspects for pharma companies. Moreover, effective product identification and traceability are required to properly identify and keep track of products and adhere to regulations that ensure patient safety.
To support your pharmaceutical manufacturing and distribution processes and help you remain compliant, you need an enterprise resource planning (ERP) system designed to meet the demands of clinical supply chains with precision and transparency.
The AXP365 Clinical Supplies™ module can significantly increase connectivity of your entire clinical supply chain. It allows managing the following aspects:
Clinical trials have been growing more and more intricate and increasing in their complexity regarding country-specific guidelines and regulations to follow. A clinical protocol—documenting the clinical study—states the study objectives, design, methods, selection and exclusion of subjects, collection schedules, and statistical considerations for analyzing the clinical research data.
The AXP365 Clinical Supplies™ module can manage the clinical study and all related information across multiple sites, including relevant study dates and the number of participants among the different investigator sites.
The AXP365 Clinical Supplies™ module allows users to link the clinical study to a project to capture all the resources, hours, expenses, and items related to the clinical trial management itself. In this way, our integrated solution enables clinical supply forecasting with predictive intelligence to anticipate the demand and optimize planning, external and internal manufacturing, and delivery.
With improved connectivity across the clinical supply chain, you increase effectiveness, speed, and cost savings in clinical trials by promptly identifying and isolating issues. You will drastically reduce supply disruptions, save time, and optimize your inventory levels—ensuring all subjects receive the proper treatment and avoid any waste of clinical products.
Life sciences companies are required to maintain complete traceability upon manufacturing active ingredients and drug products. Traceability is required to ensure consumer safety, protect pharmaceutical products from fraud and counterfeiting, and improve production efficiency.
According to the World Health Organization – Annex 5, “The manufacture of pharmaceutical products and their subsequent handling within the distribution chain, moving both nationally and internationally, must conform to prescribed standards and be rigorously controlled to guarantee their quality, safety, and efficacy”. Specific regulations related to traceability and lot genealogy are being established over time, and drugs must be traceable at the unit level as they move through the pharmaceutical supply chain.
The AXP365 Clinical Supplies™ module allows you to handle lot tracking with unique sequence numbers and printed barcoded labels and to trace the goods by expiration dates. The item-tracking functionality allows you to retrieve specific lots’ forward/backward history and full genealogy. The details include the list of components used to manufacture the batch/sub batch—with all transactions from the purchase from a vendor to the production and sale of the finished product to the customer.
With the AXP365 Clinical Supplies™ module, you ensure accurate and timely management of delivery and inventory information of raw materials, drug substances, drug products, and dispensable units.
Our solution manages full traceability of product movement from warehouse to warehouse, site to site, across the world, and with different storage conditions and restrictions to increase patient safety and security. Controls are implemented on import/export requirements to ensure only licensed/approved medicinal products are permitted to be imported (or exported) within a region unless otherwise specified. Hence it is possible to define different restrictions and restriction types for a specific batch/sub batch to ensure only approved medicinal products can be moved, shipped, or consumed unless otherwise specified.
Our module is designed to ensure life sciences companies can control their supply chains with maximum efficiency. Find out more by getting in touch with our pharma experts today.