SYDNEY – (ACN Newswire) – Asia-Pacific specialist CRO Novotech announced as part of its ongoing IT infrastructure investment program that it has implemented the Oracle’s Trial Management and Monitoring Cloud Service (TMMCS) to support its growth in the Asia-Pacific.
Oracle Health Sciences VP of Services, David Tuckfield said Novotech will have the largest TMMCS implementation in the Asia-Pacific and is the first biotech-focused CRO in the region to go-live on Oracle’s TMMCS technology in the cloud.
“We are delighted to be able to implement Novotech’s vision of next generation trial management,” he added.
Novotech, the recipient of the 2018 Frost & Sullivan Asia-Pacific Biotech CRO Company of the Year award for the 3rd consecutive year, has been operating in the Asia-Pacific for 22 years.
Novotech CEO Dr John Moller said Novotech has always invested heavily in the latest technology. This ensures regulatory compliance, allows integration into global studies, and gives Novotech teams and clients better data visibility to improve decision-making.
“Oracle’s cloud technology provides a centralized trial database enabling improved access, control and governance of clinical data. The system is highly configurable allowing us to tailor process flows and alerts to client needs, as well as ensuring effective control on deviations. Advanced functionalities like eSignatures, and tools for swift approvals and submissions help us accelerate trial implementation.”
Novotech launched the migration project in partnership with Oracle Health Science Global Services in March 2018. Novotech has also invested in Oracle Argus for Medical Safety and Oracle Inform EDC.
Novotech is a full service CRO with on-the-ground operations in Australia, New Zealand, South Korea, China, Taiwan, Philippines, Hong Kong, Singapore, Malaysia, Thailand and India with 550+ full-time employees.
Novotech clinical staff numbers have grown by more than 20% in Asia over the last quarter, fueled by demand for a regional CRO with international accreditation and reputation, combined with local knowledge, partnerships and expertise.
The CRO has extensive therapeutic area experience handling clinical studies with small and mid-size biotechnology companies across all phases of clinical trials – First-in-Human (FIH) studies to phase IV. Novotech has managed around 700 projects including the APAC component of pivotal trials for multiple FDA, EMA registered products since 2001
Novotech has now signed 10 strategic collaborations with hospitals and research institutions in the Asia-Pacific region.
About Oracle TMMCS
Oracle Health Sciences Trial Management and Monitoring Cloud Service, enables effective management of critical clinical trial activities and improved relationships with investigators, from early to late-stage clinical trials. With real-time visibility into clinical trial progress and significant utilization rates of clinic and staff resources, this solution can help to lower costs, while increasing study speed and data quality. These services are part of the foundation for Oracle Health Sciences’ integrated, holistic approach to risk-based monitoring.
About Novotech – https://novotech-cro.com/welcome
Headquartered in Sydney, Novotech is internationally recognized as the leading regional full-service contract research organization (CRO). With a focus on clinical monitoring, Novotech has been instrumental in the success of hundreds of Phase I – IV clinical trials in the Asia Pacific region.
Novotech provides clinical development services across all clinical trial phases and therapeutic areas including: feasibility assessments; ethics committee and regulatory submissions, data management, statistical analysis, medical monitoring, safety services, central lab services, report write-up to ICH requirements, project and vendor management. Novotech’s strong Asia Pacific presence includes running clinical trials in all key regional markets. Novotech also has worldwide reach through the company’s network of strategic partners.
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