What is an Almac pod?
What is an Almac pod?
According to Almac, The Almac Pod™ incorporates the company’s global courier network and advanced phase change technology (PCM) to provide a temperature-controlled shipping service solution. The company also said that since service-launch the Pod has been 100% effective in protecting the integrity of shipped products.
What is global clinical supply chain?
A Clinical Supply Chain is the chain from raw materials right through to world-wide distribution to customers (the patient). The core of any good clinical supply chain system is a supply management system that addresses all of the nuances of clinical supplies.
What does a clinical supply chain manager do?
The Clinical Supply Chain Manager is responsible for the strategic planning and execution of new clinical trial supply chains. This involves the ability to interpret a clinical trial protocol in conjunction with other key study information in order to create an appropriate kit design and formulate a strong supply plan.
What is clinical trial supply chain?
Clinical trials are a critical phase in a long and complex drug development lifecycle. These may include accurate and timely supply of drugs to patient sites, at optimum cost while ensuring compliance with regulations and Good Manufacturing Practices (GMP).
What is SAP Ctsm?
The CTSM Add-on Suite® leverages existing core supply chain management capabilities of SAP® and can be customized to accommodate the intricacies, business processes and unique requirements of clinical trials in Life Sciences.
What is EDC and IRT?
In the past, IRT systems and electronic data capture (EDC) systems were separate. An EDC system is what statisticians use at the end of a trial to analyze data, and prior to integration between an IRT and EDC, data from the IRT had to manually uploaded to the EDC.
What is statistical analysis plan?
The statistical analysis plan (SAP) describes the planned analysis of clinical trials. Compared to the protocol that outlines the analysis, the SAP is a technical document detailing the statistical techniques of research analysis.
