eStudy is Globally Accessible
eStudy is accessed via:
* Internet browser
* Windows mobile device
* Data is stored in an Oracle database
eStudy is Title 21 CFR Part 11 Compliant
* System administrators delineate user permissions for every part of the system
* Audit trail of all captured data
* Passwords required for access and to approve any type of data capture
* Validated system
* Provides signed electronic records with the users' name, date and time of signing
Data is Secure
* All communication and transfer of data is encrypted and secure
* Your data are protected on secured servers
Have it Your Way
eStudy is Adaptable to Your Workflows and Your Study Goals
* 100% Web-based solution for use in on-line and off-line modes
* eStudy Manages the Entire Study from Protocol through Report
* eStudy Manages Multiple Study Types
* Users Define and Control Study Design, Data Collection Template Design, Notebook Design, Report Template and Report Table Design
* eStudy has an Open Architecture for Simplified Customer-Specific Customizations and Interface to 3rd Party Tools
* Easy Learning Curve - Browser-based, Windows look and Feel, Utilizing Word Processing functionality and Spreadsheet Formatting similar to products the user is already familiar with
eStudy was designed by regulatory scientists with years of practical industry experience as a flexible platform to manage regulatory studies. Study Directors define and control all aspects of study design. With eStudy Manager users quickly design studies, defining test articles, treatments, test systems, samples, observations and test sites. The eStudy fundamental architecture supports a wide range of life science, biotechnology and chemical studies, such as efficacy, safety, toxicology, and pathology.
eStudy offers the ability to collect data globally and in various languages. eNotebooks are easily created and published by Study Directors. Published notebooks are accessible online to the designated users. eNotebooks are compatible with a variety of mobile devices and multiple browsers. Study data generated by human and instrument observations are recorded securely and in real time from laboratory, greenhouse and other sites. Data collection is fully compliant with EPA, OECD and FDA requirements.
Data collected from multiple sources are easily exported, collated, compiled, evaluated and shared in real time. eStudy assists study directors and investigators with simple yet sophisticated query tools.
With the ePublisher module or function, reports are generated at the project, study, or experiment level and presented in industry-standard publishing formats with minimal effort. Each report may contain text, tables and images that are simultaneously accessed from multiple data sources within and outside eStudy. Report templates are easily designed by users for in-progress or status reports to keep stakeholders informed and for final reports for submission to regulatory agencies.