Brief introduction of pinnacle 2 1 (1)

In general clinical trials, you should be familiar with the word Pinnalce 2 1. We will use Pinnalce 2 1 as a tool to generate Define.xml and validate SDTM and Adam data sets. In daily work, the word pinnacle 2 1 may just refer to a tool. I want to introduce this tool through a series of articles. This article is the beginning of this series.

First of all, Pinnalce 2 1 may refer to two versions of the tool: Pinnalce 2 1 community and Pinnalce 2 1 enterprise. The former is a free open source version, and the latter is a paid commercial version. Their developer is Pinnalce 2 1. How did the development of this company begin?

Starting from CDISC standard, CDISC has developed and popularized high-quality clinical trial data standards, and provided a clinical trial data framework to make clinical trial data easier to access and use. The standardization of clinical data needs to clean up the data according to the standards. Pinnacle 2 1 Company started with simplifying the data cleaning process. They realize that clinical trial data processing will develop towards standardization and process automation. So in 2008, they developed and launched a tool-OpenCDisc to deal with data standardization. OpenCDISC is the predecessor of Pinnalce 2 1 community and Pinnalce 2 1 enterprise.

OpenCDISC is an open source, free and plug-and-play software. Prior to this, researchers usually implemented CDISC standards manually or using expensive and bloated tools. Therefore, once OpenCDISC was launched, it was widely praised by researchers.

Before 20 10, the US Food and Drug Administration (FDA) did not force clinical trials to meet CDISC standards. However, at 20 10, the FDA's biological agent center must meet the CDISC standard. The FDA evaluated the relevant verification software, and finally chose OpenCDISC to verify and review the data submitted in clinical trials.

In the widespread use of OpenCDISC, some customers want more complex functions. 20 1 1 The contradiction between complex functions and tight R&D funds gave birth to Pinnalce 2 1 enterprise. The revenue of commercial edition can not only support the development of more functions, but also support the maintenance of open source projects. Pinnalce 2 1 Enterprise is a product based on cloud server, which can run on the cloud server and generate reports. In the same year, FDA chose to upgrade to Pinnalce 2 1 enterprise.

Under the demonstration of Pinnacle 2 1 and FDA's successful cooperation, in 20 15, Japan Pharmaceutical and Medical Device Bureau (PMDA) also adopted Pinnalce 2 1 enterprise to verify the relevant submitted data. So far, Pinnacle 2 1 has provided services for the examination and approval institutions in two key drug markets around the world. In the same year, in order to make it clear, OpenCDISC and Pinnacle 2 1, two brands had the same developer, and Pinnalce 2 1 chose to reshape the brand. They unified two versions under Pinnacle 2 1, the open source version is community and the authorized version is enterprise, which is what we are familiar with now.

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