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eStudy manager eStudy Notebook eStudy DataCipher eStudy Publisher

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Plant  •  Animal  •  Stability  •  Toxicology  •  Batch Records

Stability Studies
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The iAdvantage eStudy™ platform provides the Design Scientist with intuitive, logically organized tools to quickly design research studies into the stability of drugs or other chemical or biological products. The eStudy Manager™ module is a user-friendly, web-based graphical interface for the definition of test articles, treatments, samples and observations.

Features of this module include:
  • User-built libraries of:
    • People and companies - including names, addresses, phone, etc.
    • Test articles - including active ingredients, formulations, packaging, etc.

  • Step-wise wizards for the creation of:
    • Treatment lists - including storage environmental parameters
    • Sample lists - including generation of sample labels with barcodes
    • Observation event lists - including pull dates

  • Data Collection Template Generator, which gives the Design Scientist control over the organization and presentation of the data collection forms in the data collection "notebooks." These templates are easy to build and revise. Once built, the templates can be used repeatedly.
The data is collected using the eNotebook Manager™, a web-based electronic laboratory notebook. The Design Scientist generates these notebooks using the tools described above and publishes them to a URL. The Investigating Scientist, who is executing the study and collecting the data, accesses the notebook through a secure web-based environment via username and password permissions.

The data collection forms are completed while the user is actively online or can be downloaded to another workstation or tablet PC for data collection in a laboratory location. In addition, data can be downloaded from instruments used to monitor or measure specific parameters or from instruments used to analyze samples. Data entries and revisions are tracked through an audit trail that allows auditing of the study data for Q.A., Q.C., and regulatory compliance (GLP, 21 CFR Part 11).

Sophisticated queries and/or statistical analysis can be applied to data within eStudy without the data leaving its secure validated environment with eStudy DataCipher™. If desired, the data can also be output to other statistical packages of the user's choice and the results returned to the database.

Data is then aggregated and reported using eStudy Publisher™ by authorized users whenever they choose - from anywhere in the world with a connection to the Internet. This unique tool allows the user to design his own report templates in the word processing software of his choice - including Microsoft Word, WordPerfect, etc. These report templates are then available to be used and revised as the needed. The reports are generated by selecting the studies, product and report template. These reports can be generated in the user's choice of word processing or spreadsheet software.

By using eStudy stability studies are designed, executed and reported in an efficient and consistent manner.