GMP Clinical Supply

ACCELERATE YOUR CLINICAL SUPPLY CHAIN WITH A SINGLE INTEGRATED ERP SOLUTION. SAFELY.

Today’s clinical trials involve more patients, more sites, more countries, and more uncertainty than ever before. The number and complexity of issues affecting the supply chain has also grown to include costly comparator drugs, intricate protocols, delicate investigative compounds, adaptive clinical trials, and variable dosing schemes. Added to the mix are increased country-specific regulatory requirements, surrounding temperature-controlled drugs, packaging, shipping, and labeling.

The Clinical Supply module from AX for Pharma is a single integrated ERP solution that can significantly improve the forecasting, manufacturing, and distribution processes of clinical trial supplies. With the trend toward more elaborate clinical trials, the ability to remain flexible and rapidly adjust to changes in client demands has been a critical success factor for on-time delivery.

 

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  • The totally integrated Clinical Supply Chain.
  • Greater operational efficiency.
  • Standardization of clinical trial management.
  • Creation of a consistent approach across clinical development programs.
  • Consistent and systematic compliance management.
  • Delivery of product pipelines to market in a cost-effective and timely fashion.

 

Clinical Supply

On-time delivery and inventory

CLINICAL SUPPLY CHAIN
Because some studies involve many countries, investigators, and depots, tracking deliveries and inventory is critical.

AX FOR PHARMA
Ensures the accurate and timely management of delivery and inventory information from those involved in the clinical supply chain, including third-party logistics providers.

FEATURES:

  • Raw materials, drug substances, drug products, and dispensable units
  • Lot and container identification and traceability
  • Full lot genealogy
  • Storage conditions and restrictions
  • Internal and external manufacturing
Logistics and import/export

CLINICAL SUPPLY CHAIN
Import and export permits are a challenge with some countries. The transport and storage of product, particularly the temperature-sensitive shipments, is crucial.

AX FOR PHARMA
Supports the logistic needs to move products from warehouse to warehouse, site to site, domestic or international, import permits and licenses, special packaging and labeling.

FEATURES:

  • Management of controlled substances and hazardous materials
  • Time out of storage and temperature monitor management
  • Tamper evidence seal management
  • Import/export restrictions
  • Internal labels and shipping labels
  • Packaging and printing requests
Demand for drug products

CLINICAL SUPPLY CHAIN
Because the complexity grows fairly quickly in terms of levels of patient enrollment, the number of sites, various dosing schemes for a clinical product, it is crucial to align supply with demand.

AX FOR PHARMA
Provides visibility of demand at program, candidate, and protocol levels; improves the forecasting, manufacturing, and distribution processes to remain rapidly adjust to changes in client demand.

FEATURES:

  • Program, candidate, and protocol management
  • Population across countries and sites
  • Treatment and treatment groups
  • Dispensing matrix
  • Kit/Subject randomization list
Synchronize the supply chain

CLINICAL SUPPLY CHAIN
The manufacturing processes for APIs, drug products, packaged product, and patient kits must be included in a synchronized flow.

AX FOR PHARMA
Helps synchronize the entire supply chain: clinical demand, manufacturing, clinical packaging & labeling, inventory, quality, and R&D functions.

FEATURES:

  • Product management
  • Program, candidate, and protocol management
  • Clinical manufacturing
  • Weighing & Dispensing
  • Clinical Packaging and Labeling
  • Handheld device capabilities

AX for Pharma Fact Sheets

Other Resources

AX for Pharma is supported with a variety of insightful documents on pharmaceutical production and validation. To view our extensive resource library, simply follow the link below.

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