OmniComm Systems, Inc. a leading global provider of clinical data management solutions for clinical trials, has announced the general availability of TrialOne version 4.3. TrialOne is a browser-based, mobile, clinic automation solution designed specifically for early-phase research that facilitates subject recruitment, source data capture, sample tracking, data management and reporting. TrialOne offers time-based data entry and automates many data collection activities via its ability to both print and scan barcodes, as well as to integrate directly with medical monitoring and laboratory equipment. Furthermore, TrialOne's import and export features provide integration with laboratory information management systems for lab orders and results processing.
TrialOne version 4.3 includes numerous productivity and functionality enhancements that drive efficiencies and reduces costs through faster volunteer recruitment, flexible screening questionnaires, direct data capture, work flow automation and modern data processing.
Enhancements to TrialOne include the following:
• Comprehensive integration with bedside patient monitoring, telemetry and clinical devices with enhanced ability to send electrocardiography (ECG) orders to devices such as Mortara Surveyor™ Central System, Seca scales, and Sartorius laboratory balances.
• Enable open-label clinical study design allowing researchers and participants to know which treatment is being administered.
• Ability to read ECG tracings in real-time enabling clinic staff to effectively respond to research participants in a timely fashion.
• Study teams receive electronic notification alerts of research participant's adverse experiences allowing them to take appropriate clinical action and medical intervention.
• Enhancements in handling treatment blinding allows researchers to effectively track drugs per research participant in adherence to clinical plan and dosages ensuring adherence to clinical protocols where multiple drugs are ordered.
• TrialOne now supports open-label (no blinding), single-blinding (participant blinded), double-blinding (floor staff blinded), and triple-blinding (data extract blinded).
"TrialOne continues to set the standard for the automation of early phase clinics," stated Randy Smith, OmniComm's CTO and TrialOne Group Executive Sponsor. "The 4.3 release builds on our successful TrialOne suite providing a platform for future planned enhancements".