The Datimbi Platform is hosted in the data centers of a leading global infrastructure provider. Data centers are located in North America, Europe, and Asia. Customers may request their preferred regions for their Primary and Backup sites.
The Datimbi platform has been constructed to maximize security and data protection, and has undergone extensive security testing through an independent external testing firm. It is only through this type of process that customers trust their most sensitive data to us, such as medical records for clinical trials.
- All connections to the Datimbi Platform, including the user web application as well as web services used for data exchange, are encrypted via SSL.
- All user passwords are stored encrypted.
- Only designated Datimbi System Administrators can view and manage your account.
- If Datimbi has not been requested to provide additional support to your basic platform services, our staff will never see your business data.
The Datimbi platform has been engineered from its foundation to be FDA 21 CFR Part 11 compliant to support Good Clinical Practice (GCP). These features also add value to enterprise data management in general:
- Unique user ID, password-protected accounts, with password management policies
- Role-based security that defines the system-wide and project-specific functions and privileges assigned to a user
- All data updates (and other system events) are logged indelibly at the data field level, including the user, date/time, field definition, from and to data values, with the additional ability to provide Edit Reasons for data updates
- Integrated data Query functionality (question/answer for data quality) at the form and field levels
- Field edit and display privileges definable down to the field-level
- A robust multi-organization structure that enables managers to define which collaborators can see which data records
- A role-definable Track Changes function that enables data quality assurance staff to easily identify the set of information they need to review
What else makes the Datimbi Platform GCP validated, and what is the advantage of that to your customers?
In addition to application functionality that meets the data management and QA requirements of clinical trials and medical records management, our software development lifecycle management (SDLC) process includes:
- An overall documented software engineering management process
- Full documentation chain, from requirements through technical design
- Externally-run and verified test cases
- Comprehensive system management documentation and standard operating procedures
What this means for our customers:
- No need to validate your own software applications, thereby greatly reducing expenses, complexity, and time to go-live
- Higher overall quality
- Sustainable knowledge on the system and operations
If you need to have a Clinical Trial or other similar application to be validated, Datimbi will furnish the required evidence to the requesting authorities. Additionally, Datimbi works with test and validation experts that can help you to validate quickly the specific setup and configuration for particular studies.
The Datimbi Platform is offered as a managed service. Our customers select a subscription package that serves their particular needs, as well as additional Professional Services as required.
Subscription Packages are structured around these usage requirements:
- Single Project: This is an inexpensive way for an organization to conduct a study or manage a single business process using an enterprise-class solution.
- Unlimited Projects within a Single Client Organization: For organizations that conduct multiple ongoing studies or manage a diverse range of business processes using the software.
- Unlimited Projects, Multiple Client Organizations: This option is ideally suited for service providers that use the platform in an outsourced/OEM fashion, where many external clients are managed in the platform. Examples of this category would include Business Process Outsourcing (BPO) providers and Contract Research Organizations (CROs).
These packages all include full maintenance and technical operations of the Datimbi software platform, and upper-level technical support. For more information, please see the Subscription Packages page.
If you use one of the Single-Organization packages, it means that you use the platform for your organization’s internal use only. You are permitted to define external collaborators who have access to the system as part of your business process or study, but those collaborators may not be paying you to provide the service to them. In addition, you may not resell (or otherwise provide) the Datimbi platform functionality to those collaborators in the way that Datimbi sells the the platform to you, the subscribing organization.
This package enables OEM providers such as Contract Researh Organizations (CROs) or Business Process Outsourcers (BPOs) to provide the Datimbi platform to a number of their clients. In effect, this package comprises multiple Single-Organization/Multiple Project accounts within one license. The restriction on this package is that you may use it to deliver your service or conduct your studies to your customer base; you may not resell (or otherwise provide) the Datimbi platform functionality to those collaborators in the way that Datimbi sells the the platform to you, the subscribing organization.
No. Other than the Subscription Package you’ve purchased (Single Project; Multiple Projects/Single Organization; or Multiple Projects/Multiple Organizations), there are no additional limits on numbers of users, project size, or amount of data that can be collected.
The Datimbi platform is provided as a service, otherwise known as Software as a Service (SaaS). As such, Datimbi does not distribute its software.
In the event you have a unique scenario that requires the platform to be hosted within your data centers, please contact us to discuss your needs further.
The approach to analytics and reporting in the Datimbi Platform is to follow the 80/20 (or in many cases 90/10) rule – most of your monitoring, data analysis, charting, statistics and reporting can be performed directly in the platform. For more sophisticated processing, we make it easy for you to extract data sets to import into Excel or your preferred statistics package.
- Data Views: Enables analysts or other designated users to select columns, aggregate statistical operators, and filtering criteria using a simple drag-and-drop process to create data tables to view on screen, download, or use in charts or reports
- Charts: A variety of bar, line, and pie charts can be created to display online or download
- Reports: The platform enables custom reports to be defined using Crystal Reports and uploaded to the platform for web viewing by authorized roles
- Maps: If your data capture design includes addresses or geocodes, your data sets can be integrated within the Datimbi Platform using Google Maps
All analysis products – whether simple tabular Data Views through custom reports, are always secured at the user level, based on the assigned user roles on specific Projects. This means that regardless of how the filter criteria for a data set have been defined, you can be assured that any user viewing an analytic product can only see the data they are authorized to see.
Sometimes, the standard reporting and analysis functions in the Datimbi Platform do not meet your more sophisticated requirements. Or maybe you’ve decided you want to change data management solutions.
The Datimbi Platform offers a function whereby you can take a full project extract snapshot at anytime for download or archiving within the system. The extract contains a number of CSV files, each corresponding to forms defined in the project, study, or business process. These files can be imported into Excel, MS Access, SAS, SPSS, or many other programs.
The platform also offers secure Web Service access to Data Views and Project Extracts. With proper authorization, your external systems can access XML-based data sets and associated schema over a secure SSL link for real-time integration with your project data.
As always, the defined security models are applied at the foundation of these functions, ensuring authorized users only get the data they are allowed to see.
Defining a project, study or business process in the Datimbi platform is a combination of defining values such as workflow statuses and the graphical creation of data capture forms.
- Roles and workflow statuses are created are reused from existing definitions.
- Forms, comprising a wide array of data entry field types, are created using drag-and-drop tools. Forms can contain infinitely cascading sections each containing data entry fields.
- Role, form and “instrument” status rules are overlaid on any level of the hierarchy, from forms down through individual fields, to determine under what circumstances fields are editable and/or visible to a user.
Yes. All aspects of the system, including data field definitions, “control” data (such as statuses), lists of values used on data collection forms, menus, and other objects can be specified to use multiple languages, with EN being the default language if alternatives have not been specified.
The software provides client administration functions for you to define the organizations, users, and their overall roles in the system. These collaboration partners’ access can be activated and deactivated at the organization and individual user level. You can add as many collaborators as needed to the system, all within the terms of your selected subscription package.
How can I control which collaborators have access to specific studies, projects or business processes?
Once a collaborator and its users have been defined in the system, they can be assigned to individual studies, projects or business processes with specific (and sometimes different) roles across activities. This flexibility means, for example, that a user providing data for one study may be responsible for performing quality assurance functions on a different study.
Yes. By default, organizations providing data into the system are allowed to further view and modify their data, depending on where submitted data are in the management lifecycle. In addition, other groups who may not necessarily be data originators can be defined to have access to subsets of providers’ data. Some examples:
- Country-based groups overseeing the data provided from multiple clinical centers;
- District/county and state-level entities overseeing Municipality-level Case data
The control over which data access is granted is completely configurable depending on the needs of a particular management activity.