ClinDatrix CRO Launches Oracle EDC Tech

IRVINE, CA - ClinDatrix, Inc., a leading full service Contract Research Organization (CRO) located in Irvine, California, launches Oracle Health Sciences InForm 6.1 and Oracle Argus 8.0, to improve clinical development processes, streamline data capture, speed up trial timelines and enhance pharmacovigilance services.    ClinDatrix is a full service CRO offering pre-clinical and clinical Phase I-IV project management services for domestic and global clinical trials. Also, ClinDatrix offers clinical monitoring, medical safety management and monitoring, event planning (e.g. investigator meetings: in-person and via webinars) data management, biostatistics, programming to CDISC standards, medical writing, regulatory affairs including eCTD submissions, and quality assurance services.    ClinDatrix, a Silver level member of Oracle PartnerNetwork (OPN), plans to utilize Oracle’s best-in-class electronic data capture technology to gain deeper and faster insight into clinical trial data, which will help sponsors improve the speed, quality, efficiency, and cost of their clinical studies. ClinDatrix looked to Oracle Health Sciences InForm for a solution that would enable its clinical project teams to access real-time clinical trial data, reduce invalid data entries, expedite data availability and provide capabilities for robust clinical data reporting. Having these systems hosted on-premise in Irvine, CA can improve skill development and provide complete control of study design scheduling.   With the implementation of Oracle Argus 8.0, ClinDatrix can provide efficiencies and have the increased ability to support global safety collection and risk management efforts. Argus 8.0, including Interchange, offers efficient processing and submission of Case Safety Reports to regulatory agencies. Oracle Health Sciences InForm offers comprehensive support for industry standards, such as CDISC, to increase efficiency and time for trial design and setup and enhance data collection and reporting quality.    “Our industry-leading clinical development, management, and safety solutions empower CRO’s to optimize clinical productivity and deliver clinical data innovation and business value while managing critical regulatory requirements with confidence,” MaryAnne Rizk, PhD, Vice President of Global CRO Partner Business Oracle Health Sciences.   About ClinDatrix ClinDatrix is a privately held, full-service CRO founded in 2002. ClinDatrix provides world class, full service clinical research capabilities to the biotechnology, pharmaceutical, diagnostic, and medical device industries. Through our U.S. based staff and global affiliates, we conduct Phase I-IV trials domestically or around the world. To learn more, contact Matt Delaney, Senior Director, Business Development, at (949) 428-6676, matt.delaney@clindatrix.com or visit us at www.clindatrix.com   About Oracle PartnerNetwork Oracle PartnerNetwork (OPN) Specialized is the latest version of Oracle's partner program that provides partners with tools to better develop, sell and implement Oracle solutions. OPN Specialized offers resources to train and support specialized knowledge of Oracle products and solutions and has evolved to recognize Oracle's growing product portfolio, partner base and business opportunity. Key to the latest enhancements to OPN is the ability for partners to differentiate through Specializations. Specializations are achieved through competency development, business results, expertise and proven success. To find out more visit http://www.oracle.com/partners.