TrialOne

The Operating System for Early Phase Research™


This enterprise solution addresses the distinct challenges of Phase I/IIa studies and the unique requirements of Early Phase Clinics worldwide.

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The Number One Proactive eSource and Early Phase Clinic Automation Solution

TrialOne is the number one proactive eSource and Phase I site automation solution for your early phase clinic operations. Whether it be volunteer recruitment, real-time study data collection or SAS data exports, TrialOne will handle all your study protocol needs. This web-based, tablet compatible system provides an advanced platform for automating your clinic operations and complies with FDA 21 CFR part 11 as well as supporting standards such as CDISC for easy import, export and reporting of data.

Phase I protocols can change quickly, but with TrialOne, last-minute setup and study schedule changes are easily managed, even after a study goes live. TrialOne meets the demands of early phase clinical research units with a web-based interface allowing for quicker decision making, extensive reporting functionality and on-demand data export capabilities supporting the latest CDISC standards.

TrialOne helps drive efficiencies and reduce costs through faster volunteer recruitment, flexible screening questionnaires, direct data capture (DDC/eSource), work flow automation and modern data processing. The stream-lining of processes allows TrialOne to save time while increasing quality through enhanced user prompts leading to fewer mistakes and less data queries.

TrialOne Modules

Subject Recruitment

A very time-consuming aspect of conducting a clinical trial is subject recruitment so with tight deadlines it is imperative volunteer enrolment is as smooth and efficient as possible. TrialOne helps reduce the time it takes to get a drug to market by letting you collect the data you need about each subject. There are no limitations as to what information can be collected and users can even search a subject’s medical history from past clinical studies.

TrialOne allows the recruitment team to keep track of advertising campaigns as well as a subject’s interest in a particular study. Volunteers are enrolled into a study after successfully passing inclusion/exclusion criteria allowing customisable study entry controls to be maintained. Communication in the form of letters, emails, text messages, or phone calls can be sent to subjects to remind them of upcoming screening and study visits.

The dynamic subject database facilitates sites to maintain a pool of volunteers with only the data collection fields applicable to the site, meaning no more empty fields. Subject and study specific data remain separate but users can still securely query across datasets.

Data Collection

Study Data Capture

Gone are the days of collecting information on paper forms which were then sent to the research sponsor, because with TrialOne data can be collected from offices, hospitals and universities throughout the world by physicians, nurses, and research study coordinators using TrialOne’s proactive real-time web-based Electronic Data Capture system.

Electronically confirm a volunteer into a visit by scanning their ID badge and start collecting data right away. The clear and intuitive data capture screen provides a fast and user-friendly method of collecting the information that is most important for your clinical trial. Connect directly to a blood pressure machine for consistent and accurate results without the need for double data entry. Scan barcodes to verify the correct specimen container is being used and record the collection time with a USB attached footswitch.

At OmniComm we believe it is not just important to collect data but also to quickly view the data without having to apply complicated filters or run time-consuming reports. With this in mind, TrialOne includes the ability to design pre-set data filters for viewing adverse events, concomitant medications, dose times and imported laboratory results across subjects in a study.

Subject Screening

TrialOne is perfectly suited to this important step of a clinical trial because its data collection abilities are designed with the user in mind. Questionnaires are designed with an intuitive “drag-and-drop” design tool that allows for the rapid structuring of conditional event branching as well as customisable tracking tasks for safety samples.

With TrialOne each stage of a clinical trial can be controlled with protocol driven inclusion and exclusion criteria.

ODM Data Service (API)

There are many different types of API (Application Programming Interface) but what sets the TrialOne API ahead is it is CDISC ODM compliant. The TrialOne API is a RESTful (RepresEntational State Transfer) data service that provides a rich and uniform vocabulary for external applications to communicate with TrialOne. Study parameters as well as collected data are presented as an XML document on both a study and clinic-wide basis for consumption by third-party tools.

Sample Tracking

Samples collected at the bedside or from blood draw stations can be tracked throughout the site to ensure the time from collection to freezer is within the times dictated by the protocol. Lab technicians can operate the extremely user-friendly interface through wall-mounted touch screen monitors to record the chain of custody and manage shipping tasks. Aliquots can be checked-in, centrifuged and separated either individually or within a batch. Subsequently, batch barcodes can be scanned to speed the process of moving a group of samples between locations in the laboratory.

Label Preparation

Pre-printed sample labels are often required to be prepared for each volunteer and time point as defined in the clinical protocol. Quickly and easily design labels using NiceLabel Pro then seamlessly print sample labels within TrialOne. As well as system generated barcodes, TrialOne supports external barcode labels allowing the site to cater for all sponsor needs.

Data Management

Data Imports

Oftentimes it is necessary to import data from an external source such as a laboratory, centralised ECG system or from patient diaries. TrialOne has an automated file import utility which will monitor a drop location such as a folder on a shared drive or FTP/SFTP site. The import utility will then process the file into the TrialOne database for immediate display against the appropriate data point on the schedule.

Data Exports

Statisticians and programmers devote a large amount of time and effort to map and transform clinical data from a data model optimized for data entry, cleaning and monitoring to the domains required for data analysis and reporting.

The TrialOne data export utility allows for the definition of domain variables using industry standards such as CDISC CDASH and for the mapping to site data collection objects. Export requests are configured using the intuitive interface allowing exports to be run immediately, providing efficiencies for statisticians and data managers alike. Data can be exported as ASCII delimited files or SAS datasets for immediate loading into industry standard statistical packages.

Data Review

With TrialOne, data is no longer copied from paper case report forms, which can produce errors that are not caught until weeks later; instead, the visibility of a patient’s medical status can be accessed in real-time by the sponsor through the online review tool. In addition, monitors can raise queries and expect rapid responses through the query resolution features integrated with the data collection screen.

Reporting

System Reports

A variety of canned reports are included with TrialOne to assist users in retrieving data in a standard format. Examples of these reports include blank case report forms, completed case report forms, adverse events by study and subject, study schedules, subject information, sample task summary and user details with assigned security.

Ad Hoc Reporting

Providing the ability to create ad hoc reports is an important step to releasing collected data from any EDC system. TrialOne allows users to easily create and share sophisticated reports with charts and graphics with colleagues as well as providing the ability to share critical insights to a wider audience outside the organization. TrialOne Ad Hoc Reporting is provided through a seamless interface to the LogiXML Ad Hoc reporting package, accessible by any web-browser. The simple wizard interface opens up numerous opportunities for creating comprehensive dashboards and intelligent reports facilitating the analysis of data as it is collected in real-time.