Clinical Data Management:
At Digitrix, our clinical data management and consultancy services are dedicated to providing you with clinical data, data analysis, and regulatory support and presentation requirements.
The increasing role of a dedicated Clinical Research Organization in your company's clinical data requirements.
At Digitrix, our clinical data management and consultancy services are dedicated to providing you your clinical data, data analysis, regulatory support and presentation requirements. Within clinical data management, optimal therapeutic designs, customer support and customized data analysis are key areas where our bio statisticians and medical writers interact to provide comprehensive solutions. Only through an all-inclusive understanding of study objectives, clinical design issues, and upgraded quality control measures, can maintenance of the quality of data and adherence to expected deadlines be achieved. Analysis of clinical trials includes pharmacokinetic and dynamic evaluations, therapeutic equivalence testing and sequential designs.
Our Clinical Data Management Services
- CRF Development
- Case report form design, production, and tracking
- Clinical Data Entry
- Data entry cleaning
- Case report form review
- Automatic edit checking and query tracking
- Medical Coding
- Coding of adverse events (meddra, who-art, costart)
- Coding of concomitant drugs (who drug centralized data coding)
- Clinical Database locking
- Clinical Data transfer specification (CDISC-SDTM and Sponser specific)
SAS- Clinical Data Integration
Integrates clinical, operational and safety data from multiple sources.
- Protects your investment in legacy operational systems and data.
- Integrates with Medidata Rave® and other leading EDC systems.
- Enables access to all data regardless of source or format.
- Automates data loads for clinical data on a more frequent schedule.
Prepares uniform, consistent data for analysis.
- Includes flow control, integrated error reporting, job performance monitoring and statistics, and reporting.
- Provides tools to support aggregation of data across clinical trials.
- Provides a full mapping of data source (where data came from), data manipulations (how the data has been manipulated) and the final destination for data.
- Helps you plan for and report on the impact of any process changes, including:
- Changes to incoming data formats.
- Changes in data standards.
- Additional data requirements for analysis data sets.
Enhances data quality to ensure trustworthy analytical conclusions.
- Automates data quality activities so less time is spent validating incoming clinical data.
- Automatically incorporates data quality techniques to ensure consistent, trusted and verifiable clinical information.
Supports data standards and performs adherence checks.
- Performs standards adherence checks.
- Includes prebuilt support for CDISC models, including SDTM and CRT-DDS (define.xml), and is extensible for custom models.
- Provides specialized transformations for mapping clinical data to a standard model.
- Matches the application of standards to study requirements.
- Provides lifecycle management for standards as they evolve.
- Increase operational efficiency while lowering costs.
- Automate repeatable tasks to free up resources for higher value-added tasks.
- Increase your capacity to handle additional trials, as well as more complex global trials.
- Write and validate less code, and potentially reuse code for future trials.
- Scale clinical studies without adding expensive, hard-to-find headcount.
- Manage and reuse information stored in a common repository to reduce both development and maintenance time.
- Support adaptive trials through rapid access to clinical data.
- Drive top-line growth.
- Leverage existing clinical data to make new marketing claims or discoveries.
- Speed data preparation for medical publications.
- Automate the migration of acquired data assets through data standards.
- Support and automate data aggregation and standardization for ongoing clinical trials.
- Ensure the proper use of standards.
- Validate both the structure and content of data for conformance to CDISC SDTM.
- Standardize data to CDISC SDTM using prebuilt data models and processes.
- Visually convert legacy data to standard data.
- Deliver consistent, trusted and verifiable clinical information.
- Aggregate information from virtually any hardware platform or operating system.
- Address potential issues before they affect your study by automating data quality and data transformation routines.
- Improve productivity.
- Build and document work with a user-friendly GUI interface.
- Reduce the need to write unique code for each study.
- Get new team members up to speed quickly on work done by others.
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BENEFITS AT A GLANCE
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- Scalability. Provides high-availability load balancing and centralized management of large server farms.
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GO-Global Cloud consists of three components:
- GO-Global Host
- GO-Global Cloud Server
- GO-Global Cloud Client
GO-Global Windows Host 4
GO-Global Windows Host 4 Web-enables Windows applications without having to modify them. Local and remote users access the applications just as though they were running locally. Existing Windows applications can be Web-enabled in as little as 15 minutes, retaining 100% of their features, functions and branding. To learn more, refer to the GO-Global Windows Host 4.0 data sheet.
GO-Global UNIX Host 4
Coming soon from GraphOn® will be GO-Global UNIX Host 4 to Web-enable UNIX and Linux applications for global access via GO-Global Cloud. Currently, GO-Global for UNIX 2.2 is available as a standalone solution for UNIX/Linux application delivery.
GO-GLOBAL CLOUD SERVER GO-Global Cloud Server provides a high-availability, secure gateway to GO-Global Hosts. Administrators have extensive control over user rights and privileges, allowing them to monitor and manage clusters of GO-Global Hosts. Users can access and share applications, files, and documents via simple hyperlinks. And developers can integrate Windows and Linux applications into their Web-based enterprise and workflow applications.
GO-GLOBAL CLOUD CLIENT
Users running Windows, UNIX, Linux, Mac OS X, or portable devices access and manage GO-Global Hosts by running the GO-Global Client, available as a native client or browser plug-in. Alternatively, users can connect from any platform by simply using a Web browser that supports Adobe Flash 9 or later.
A SECURE GATEWAY TO THE WEB
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GO-GLOBAL CLOUD FEATURES
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Flash-based Client and HTTP Tunneling. With other application delivery solutions, users are often unable to access applications because they do not have rights to install a required plug-in, or firewalls and proxy servers prevent the connection. GO-Global Cloud solves these problems by allowing access through any Flash-enabled browser and by using standard ports (Port 80, for example) and protocols (HTTP, for example).
Users can securely access and share documents and files from GO-Global Hosts. Depending on access rights, users can view and edit documents whether or not they have the corresponding application installed. The documents never have to leave the secure GO-Global Host.
Virtually all GO-Global Cloud features can be controlled programmatically from Web-based applica¬tions using the GO-Global Cloud Web API. Developers can start sessions, authenticate users, create user-private workspaces, move files to and from a workspace, start and stop applications, and monitor server usage.
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Secure Architecture. Robust authentication and access control options allow GO-Global Hosts to be accessed securely over the Internet.
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Administrators can easily shadow sessions, terminate sessions, and evaluate user and session resources.
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Private VDI. Users and administrator can see a full desktop view of the Host in a private session•