Our Product Suite
TrialStat® delivers data solutions on-demand for pharmaceutical, biotechnology and contract research organizations. Our TrialStat eClinical Suite™ consists of three product offerings for the EDC, CTMS, and Portal. We stand alone in the industry with such an all-compassing suite of products for conducting clinical trials.
For questions about any of our products or services, please contact us.
EDC Component of the eClinical Suite
TrialStat Orbit™ - Our EDC solution offers a comprehensive range of features that enhance the collection, management, cleaning and auditability of clinical data. The user-friendly web browser interface, configurable study design, integrated reporting, and powerful data management features accelerate decision making and reduce overall operational costs. Unlike other EDC systems, we average a 5-week data build opposed to a typical 8-9 week window, offer a subject log-in module capturing e-diary data eliminating the need for hand held devices and is scalable for all phases of clinical studies. Our global team allows for precise planning of any system maintenance downtime with minimal or no impact to sites.
More features of Orbit:
- Integrated Reporting (+) simplifies the ability to retrieve, isolate and audit data using configurable and drag and drop tools that can graphically display information for analysis.
- Browser Configurable Aggregated Study Reporting defines complex reports across multiple data sets, including audit trail information, and posts the results graphically in a variety of formats, such as Excel, SPSS and SAS. Users can configure four kinds of reports:
- Visit Reports – Shows how subject data has changed over the length of a study using graphical reporting to track data changes across different visits.
- Summary Reports – Compares relationships between fields and/or subjects to data elements.
- Data Listing – Allows the select extraction of selected subject form data with audit and data clarification form information.
- Dictionary Coding – Pulls the results of coding progress to analyze and verify consistency. In addition, users can just click the Coding link under Forms and view an activity task list, which provides an overview of ongoing and completed work. This enables users to quickly assess the status of dictionary coding quickly.
- Real-time Monitoring, Reporting and Validation automates patient and site-level reports, query generation, form completion, adverse events and Microsoft® Word documents using customizable dashboards. Orbit's dashboards provide a snapshot on a study progress. Designers can configure and display different graphical charts in addition to illustrating summary data.
- Study Metrics Report streamlines the management of your study in real-time by providing concise design and metrics reports. From incremental data reports to DCF status, Orbit offers 16 standard out of the box reports provided to summarize study data.
- Patient Milestone Reporting creates a macro view of patient timelines to better manage scheduling and overall study performance.
- Project Management freezes a project design to manage iterations and allow for controlled changes to be made on copies of the original design. As part of the protocol amendment work flow, project freeze ensures the continuity of projects, while optimizing the ability of users to make changes to copies that can be incorporated into the original design upon approval.
- Data Management (+) provides robust validation, data export in multiple formats, randomization and dictionary management.
- Easy to Use Interface with embedded conditional branching ensures that sites are presented with relevant data fields for entry based on their responses to leading questions. Real time data cleaning capabilities assist in accurate capture of data at the time of initial entry at the sites
- Dictionary Management automates the administration of MedDRA and WHODrug Dictionaries, which enables users to access, release and maintain coded records of patient safety data.
- Industry Standard Data Export uses an easy-to-use wizard to export data to Excel, SAS and SPSS for analysis or a custom report design.
- Interactive Discussion Forum provides a secure platform to post messages and share documents from multiple sites. With read, access and edit permissions, data managers can create groups and sub-groups with select access to available documents and discussion areas.
- Integrated Data Clarification Form (DCF) Management accelerates and streamlines data cleaning. Users can raise, clarify, interact, log resolution and audit DCFs.
- Source Data Verification (SDV) Tracking records and audits SDV signature and dates after it has been completed.
- Electronic Signature accounts for electronic signature and dates for the completion and accuracy of eCRF form data. Permitted users utilize controls to identify eligiblibility for electronic signatures.
- Document Generation configures event-driven document generation to produce documents reporting Adverse Events, CIOMS and Medwatch data.
- Configurable Study Design (+) allows for the customized creation of eCRFs, templates and reports through a browser interface.
- Comprehensive Study Editor configures every aspect of your data capture and management needs, including eCFRs, reports and document templates. In addition, this features offers:
- Form-based validation rules
- Multilanguage support
- Configurable visit structures
- Integrated randomization capabilities
- Form Reuse streamlines and simplifies the management of standard and customer-created form libraries, enables users to re-use existing eCRFs to speed study start times.
- Web-based Randomization enables real-time blinding of study participants through a secure browser interface, eliminating the need for costly IVRs systems while supporting adaptive clinical trial designs.
- Flexible Data Capture (+) includes innovative image-based eCRFs and Web-based ePRO to speed overall data collection and management.
- Image-based Data Capture allows users to enter data by interacting with animated and three-dimensional eCRFs, simplifying data entry and management. As well, users can attach images, such as digitized x-rays and photos, to forms.
- ePRO collects data through a secure browser interface to significantly reduce data collection errors associated with paper methods, such as transcription errors and patient consent.
- Annotated CRF displays all questions and design fields in an easy-to-read format, annotated CRF enables customers to confirm and approve their design in real-time, speeding data entry and overall trial management.
- Wireless Data Capture collects from any connected device, such as laptops or PDAs, data through the Internet and browser.
- Multi-language support is available for forms.
Sponsors and CROs want more robust reporting functionality from their EDC platform – without having to pay extra for it. That's why Orbit uses innovative reporting technology that enables you to create either granular or more global reports of your data. With drag and drop simplicity, Orbit streamlines your ability to retrieve, isolate and audit data using configurable features that graphically display information for analysis.
Customers now no longer have to purchase additional third-party reporting tools. Rather, with Orbit, they have advanced and powerful reporting tools that create, assess and validate data simply. Configurable report functionality and an easy-to-use interface, meanwhile, enable rapid adoption across different users with different levels of technology sophistication. From patient scheduling to aggregate reporting, Orbit makes it easy for you to report on the progress and results of your study in real-time.
Integrated Reporting Features:
You shouldn't have to be an Oracle database programmer to use your EDC solution. The diverse range of EDC users, from registered nurses to data managers to a VP Clinical, requires a solution that can manage data simply, as well as be deployed in multiple clinical environments.
Whether it's a small Phase I study, or a large international post-marketing registry, Orbit provides easy-to-use features that enable sponsors and CROs to automate the management and validation of their data on demand. This allows you to review, identify and approve data across sites, trials and global locations in real-time, on demand.
Using permission-based rules, Orbit enables users to code with standard or custom dictionaries and to utilize configurable reporting and query tools. With an intuitive browser interface, Orbit eliminates the need to hire expensive database experts. All your organization needs is access to a Web browser.
Clinical Data Management Features:
Your EDC solution should work the way you work. It should mirror your organization's workflow, while accommodating the unique requirements of different studies of all sizes, phases and therapeutic areas. User configurability is an important first step to ensuring that your EDC solution works for you – letting you focus on clinical research rather than software programming.
With a browser configurable interface, Orbit can be deployed faster than any other EDC platform. Users can design and manage all aspects of their studies through easy-to-use wizards and templates, accelerating the deployment of their trials. Flexible permission-based controls and real-time data access ensure that authorized users can review their data and meta data whenever they want. This flexibility allows customers to add new information to their trial, or even change its design after protocol amendments.
Configurability also extends across different functional areas. Collaborative discussion forums, for example, allow users to create groups and subgroups and control read/access/edit permissions separately to better manage communication and sensitive information exchange, such as adverse events or medical images, among researchers. In addition, data managers can configure specific workflows, procedures and processes to more efficiently manage their trial and the accuracy of its data.
Configurable Study Design Features:
Innovative new ways to capture data enable you to complete your study faster and more accurately. That's why Orbit has some of the industry's most advance and flexible data capture tools.
As an industry first, Orbit's image-based data capture is an innovative technology that allows clinicians to capture and visualize data graphically though interactive images on the screen, reducing the time to complete forms and dramatically improving accuracy. The industry's first on demand EDC solution also provides fully integrated support for bar code scanning to facilitate and accelerate the collection of patient, lab and prescription data. Data captured with a bar code scanner can also make use of Orbit's standard real-time data validation capabilities, ensuring its accuracy and overall quality.
Electronic Patient Reported Outcomes or ePRO uses a secure browser and password-protected interface to allow patients to enter data. Its easy-to-use interface enables patients of different levels of technology sophistication to enter data simply and fast, ensuring more accurate data collection than with paper-based and IVR data collection methods.
Flexible Data Capture Features:
For researchers under the pressures of time and cost constraints, TrialStat Orbit is:
- Rapidly Deployable: Orbit is the only 100% browser configurable EDC platform that lets you deploy complex projects in days, not months;
- Cost Effective: Orbit's hosted platform means that there is no IT to set up and manage and no software to install at sites. This, combined cost saving user confi gurability features, can significantly reduce your EDC costs
- Beyond Conventional EDC: Orbit incorporates a host of features you won't find in any other EDC platform. Features, such as single click deployment to mobile devices, imagebased forms, bar code integration and encryption, ensure that Orbit adapts to how you conduct research, not the other way around.
Portal Component of the eClinical SuiteTrialStat Portal provides ultimate study management through real-time visualization of study data. It seamlessly integrates with all TrialStat products creating user dashboards to drilldown and retrieve data. Portal enables users to make critical decisions for managing a study.
CTMS Component of the eClinical SuiteTrialStat-COMET is the CTMS module of the TrialStat eClinical Suite. It will seamlessly capture and report dynamic data from clinical operations and data management functions. A variety of reports will be available through easy-to-use reporting dashboards. A dynamic and intelligent reporting module will allow for a user-friendly reporting dashboard that will enhance your trial management.
The heart of any SaaS-based application is its data center. TrialStat® services are hosted in an ultra-secure and high availability data center in New Jersey.
The New Jersey data center has 100% uptime guarantee powered by renewable energy with multiple backup generators. Additionally there are multiple Tier 1 network providers and a dedicated fiber ring for full redundancy. Fully redundant data backup, extensive and layered firewall protection and an array of security requirements, including onsite video surveillance, retinal scans, locked server partitions and 24h security personnel, ensure that your data is secure and fully protected.
What's more, the data center is SAS 70 Type II certified and HIPAA Compliant. TrialStat's data center supports international studies in over 15 countries with more than 3000 users, accommodating our customers' ability to scale with the changing requirements of their studies - to access data on demand.
- Customer Focus
- Data Management
- External Collaborations
- Rapid Turnaround Time
- Team Approach
- Dermatology trial conducted in India with over 50 sites and 1200 subjects.
- Jubilant Clinsys was contracted to perform database design and validation, full data management, biostatistics and eCTD compliant CSR submission activities for the client.
- Clinical and safety monitoring activities were conducted by a different CRO.
- Extremely aggressive timelines since the client wanted to submit the FDA application before end of the year.
- Customer Focus
- Data Management
- Global Processes
- Rapid Turnaround Time
- Team Approach
- Dermatology trial conducted in US, Belize and India with over 25 sites and 800 subjects.
- Jubilant Clinsys was contracted to perform database design and validation, full data management, eCTD compliant CSR submission, US and Belize clinical and medical monitoring activities for the client.
- Clinical and medical monitoring activities for India were conducted by a different CRO.