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Often, a clinical trial management system provides data to a business intelligence system, which acts as a digital dashboard for trial managers. [5] [6] [7] CTMSs allow experts easily to access centralized data and thus reducing the number of delayed trials. Sponsors can work with a database of previously researched contacts and names of ...
Matched or independent study designs may be used. Power, sample size, and the detectable alternative hypothesis are interrelated. The user specifies any two of these three quantities and the program derives the third. A description of each calculation, written in English, is generated and may be copied into the user's documents.
The table shown on the right can be used in a two-sample t-test to estimate the sample sizes of an experimental group and a control group that are of equal size, that is, the total number of individuals in the trial is twice that of the number given, and the desired significance level is 0.05. [4]
PASS is a computer program for estimating sample size or determining the power of a statistical test or confidence interval. NCSS LLC is the company that produces PASS. NCSS LLC also produces NCSS (for statistical analysis). PASS includes over 920 documented sample size and power procedures.
An electronic trial master file (eTMF) is a trial master file in electronic (digital content) format.It is a type of content management system for the pharmaceutical industry, providing a formalized means of organizing and storing documents, images, and other digital content for pharmaceutical clinical trials that may be required for compliance with government regulatory agencies.
Medidata Solutions is an American technology company that develops and markets software as a service (SaaS) for clinical trials.These include protocol development, clinical site collaboration and management; randomization and trial supply management; capturing patient data through web forms, mobile health (mHealth) devices, laboratory reports, and imaging systems; quality monitor management ...
Clinical data management (CDM) is a critical process in clinical research, which leads to generation of high-quality, reliable, and statistically sound data from clinical trials. [1] Clinical data management ensures collection, integration and availability of data at appropriate quality and cost.
SAP GUI is the graphical user interface client in SAP ERP's 3-tier architecture of database, application server and client.It is software that runs on a Microsoft Windows, Apple Macintosh or Unix desktop, and allows a user to access SAP functionality in SAP applications such as SAP ERP and SAP Business Information Warehouse (BW).