OmniComm Systems, a leading strategic software solutions provider, has been selected to provide electronic data capture (EDC) software and services to a major contract research organization (CRO) with locations in the United States and Europe. The deal is the latest contract in a string of recent international partnerships. Under the terms of the most recent deal, the CRO will utilize OmniComm’s TrialOne system to standardize clinical development programs, ensure regulatory compliance and bring greater operational efficiency, speed and quality to the clinical research process within its clinics.

 

OmniComm provides comprehensive solutions for clinical research with experience from over 5,000 clinical trials. Through the use of innovative and progressive technologies, OmniComm says it helps the life-sciences industry to drive efficiency in clinical development, better manage risks, ensure regulatory compliance and manage clinical operations performance. Its TrialOne system is a browser-based data collection technology specifically designed to automate the workflows and processes within early-phase research clinics. 

 

The CRO will use TrialOne to implement a number of automated clinical trial processes across multiple clinics, including the recruitment and screening of subject participants, study design work and the collection, analysis and reporting of data. Future project initiatives will include multiple interfaces with clinic equipment such as blood pressure sensors and electrocardiogram devices. The CRO reportedly chose TrialOne because of its ability to manage and optimize patient screening and recruitment, implement data capture from subject at the bedside, automate data capture from medical monitoring equipment and devices, streamline staff training and support records and integrate with laboratory information management systems for lab orders and lab results processing.

 

“With this project award, TrialOne’s position as the market-leading eSource solution for Phase 1 clinics is now solidified,” said Kuno van der Post, OmniComm’s chief commercial officer. “We are absolutely thrilled to have been selected, more so as it comes after a period of significant investment within OmniComm in both product quality and highly skilled support resources. The timing could not have been better.”

 

OmniComm also recently signed its fourth and fifth contracts to implement TrialOne in China, all since it made its debut there in December 2016. Regulatory changes in China have increased the importance and necessity of clinic automation systems during clinical trials. Currently, early-phase research centers lack the systems needed to manage clinical trials, while addressing the regulatory requirements for data quality and integrity.

 

TrialOne was selected for several reasons, including its ability to support the Chinese language. As a system that is compliant with global industry standards and best practices for Phase 1 clinical research, TrialOne helps user organizations to ensure the quality and integrity of the data collected and managed during the clinical trial process. TrialOne’s ability to enable users to comply with Chinese FDA regulations aimed at harmonizing local practices to global standards was also a key factor influencing its adoption.

 

“TrialOne is rapidly being recognized as a solution that can help Phase 1 clinics and early-phase research organizations in China to standardize their processes, manage compliance with regulatory requirements and international standards, secure data integrity and data quality, while at the same time increasing the efficiency of their operations,” said Wolf Ondracek, managing director and senior vice president at OmniComm. “These two new customers—one located in Guangzhou—add to the geographical spread of TrialOne implementations in China, and this strengthens our confidence in the potential for impressive TrialOne growth during the course of the year.”

 

Over the last year, OmniComm’s reach has broadened across the globe. In addition to being chosen by a number of top hospitals and research universities around Europe and the United States, the company’s expansion into China is complemented by major contracts in Canada, Israel and Australia. One of its signature products, TrialMaster, supports any number of languages, meaning a trial can be designed and built and the metadata translated into the desired languages so that users can pick the language of their choice. According to their website, the clinical data itself is effectively language-agnostic, since numbers and dates are universal while coded fields contain an internal value rather than a language-dependent label. Only free text fields may need manual translation. This means, for example, that a trial may be conducted in English, Spanish, French and Japanese, but be analyzed in English.