Established in April 2000, DreamCIS is a contract research organization (CRO) providing clinical trial services to the clinical development industry. Its 210 clients include pharmaceutical companies, biotechnology firms, medical device manufacturers, and functional food producers. It received the 2009 Future Leading Company & People (Pharmaceutical Industry) award from Korean media company Herald Biz, and the grand prize in the 33rd National Productivity Awards (Human Resources Development Division) from the Ministry of Knowledge Economy in September 2009.
To fulfill its vision of becoming the top CRO in Asia and a leader in international clinical standards by 2019, DreamCIS implemented a clinical data management system, based on Oracle Clinical, Oracle Remote Data Capture, and Oracle Thesaurus Management System. The new system meets international standards for clinical data management and enabled the company to improve the accuracy and security of clinical data. It can also conduct a single clinical trial from various locations worldwide and monitor the status of the trial in real time. In addition, DreamCIS has reduced the cost of clinical trial data searches by 66% and cut search time from 7.4 seconds to 0.063 seconds.
As Korea’s market share in the global pharmaceutical industry continues to grow, there has been a corresponding demand for a system that can manage clinical trial data more effectively. In particular, it has become essential to provide clinical trial services that conform to International Conference on Harmonization—Good Clinical Practice Guidelines, as well as the local regulations and guidelines of the countries in which clinical trials are conducted.
In addition to its unpredictable performance issues, DreamCIS’ legacy clinical data management system was based on simple storage and management functions, which affected the quality of data. The company decided to replace its in-house systems with a more advanced platform to ensure the reliability and accuracy of clinical trial data, improve the efficiency of clinical studies, and meet international clinical trial standards.
DreamCIS began using Oracle Clinical and Oracle Remote Data Capture in January 2010. It was the first Korean CRO to implement these products, and within 24 months was using the system to manage more than 60% of client projects. The utilization rate of the Web-based Oracle Remote Data Capture application has reached 40% for all projects, and customer satisfaction ratings have steadily risen over the years. In March 2012, the company went live on Oracle Thesaurus Management System to further improve clinical trial data quality.
Oracle Clinical enabled DreamCIS to electronically capture and manage clinical trial data in an integrated fashion, and comply with best-practice, clinical trial procedures. The company can modify data without deleting previously entered information, avoiding data loss during the conversion phase by keeping the source information intact even as it is being processed.
The easy-to-use interface allows researchers, inspectors, and site coordinators to input and delete data, monitor the status of clinical trials in real time, and track source documents throughout the trial to validate their accuracy. By improving the integrity and reliability of clinical trial data, DreamCIS has enhanced customer service and maximized productivity.
Based on experience and technical expertise accumulated from using Oracle Clinical and Oracle Remote Data Capture, DreamCIS recently implemented table partitioning, a technique that involves managing a single storage device in logical partitions. The company has reduced management tasks for clinical trials, increasing the productivity of IT staff members and improving the efficiency of database and system management. Partitioning has also allowed DreamCIS to diversify system restore points and enhance system performance.
As a result, DreamCIS has reduced the cost (based on system use) of clinical trial data searches by 66%—from US$8 per search to US$3—and cut search time from 7.4 seconds to 0.063 seconds.
The implementation of the Oracle clinical data management platform has enabled DreamCIS to communicate with overseas partners and participate in multinational clinical trials. For example, Oracle Remote Data Capture provides access to clinical data regardless of different document formats and electronic data capture methods used by global pharmaceutical and biotechnology clients.
The Web-based Oracle platform gives DreamCIS the ability to conduct a single clinical trial from various locations worldwide. It also raises the utilization rate of clinical studies and enables the company to provide clinical trial services that meet international standards, the quality of which has been validated in two inspections by the Korea Drug and Food Administration. This is particularly important, as the company runs multinational Phase III clinical studies involving 23 Asian institutions in India, Indonesia, Korea, the Philippines, and Thailand. The ability to carry out joint research with collaborating bodies internationally has resulted in more cost-efficient online global clinical studies.
To complement Oracle Clinical and Oracle Remote Data Capture, DreamCIS implemented Oracle Thesaurus Management System, which provides a centralized, globally available repository of medical terminology. The system also contains specialized medical terms and functions used by the US Food and Drug Administration and MedDRA MSSO.
By integrating these products, DreamCIS ensures the quality of clinical trial data management for clients and enhances its role in the biotechnology industry. The company uses the Dictionary Management, Coding, and Browsing functions to sort clinical trial data, based on global standards. In addition, Oracle Thesaurus Management System offers a stable architecture that ensures reliable, convenient access to these functions, significantly improving work efficiency.
As the first CRO in Korea to adopt Oracle Clinical and Oracle Remote Data Capture, DreamCIS has hosted a range of activities, including seminars, for industry stakeholders. These seminars aim to raise the standard of Korea’s clinical trial data management by educating stakeholders on how to be compliant with domestic and international regulations and conditions.
As the importance of stringent clinical trial data management increases, DreamCIS plans to implement other Oracle Life Sciences applications to improve performance and stability. This will enable the company to expand its scope of services. It will also allow it to improve client service and trust, enhance its ability to compete on the global stage, and meet goals of becoming Asia’s top CRO and a leader in international clinical standards by 2019.
Organizations in the pharmaceutical sector need specialized solutions that are supported by a deep understanding of the industry’s unique processes and tasks. Above all, when data is processed through a clinical-trial data management system, the system’s accuracy, reliability, security, and operational consistency must be validated.
As DreamCIS conducted multinational clinical trials and receives collaboration requests from CROs in Asia, Europe, and North America, the company needed to implement a data management system that met international standards, based on audits of foreign-based subsidiaries by the parent company. DreamCIS also wanted to improve its global competitiveness in the CRO industry.
“It is important to deploy a stable research system that meets international standards,” said Ko Hee-jung, director, biometrics center, DreamCIS. “The ability to strengthen business capabilities and increase sales using such a system is key to the company’s success.”
After reviewing solutions that would meet the special requirements of the medical market, DreamCIS chose Oracle Clinical, which complied with International Conference on Harmonization’s good clinical practice guidelines and the regulations of various countries. The application enables quick and open communication with global clinical trial partners in the medical and pharmaceutical industry. The company also selected Oracle Remote Data Capture, which has the same data model and architecture as Oracle Clinical, to offer online access to clinical trial data and facilitate international collaboration.
DreamCIS must also ensure it uses the correct code for pharmaceutical terms. The organization selected Oracle Thesaurus Management because the software offers a dictionary of common pharmaceutical terms and their matching codes, ensuring DreamCIS uses globally accepted terminology in its clinical trials. Oracle Thesaurus Management also accommodates diverse clinical regulations and can be expanded to include more terms and codes. In addition, the software is integrated with Oracle Clinical and Oracle Remote Data Capture.
DreamCIS implemented Oracle Clinical and Oracle Remote Data Capture in May 2009 and went live in January 2010. Oracle Thesaurus Management System was deployed in September 2011 and went live six months later in March 2012.
Oracle Specialized Partner DBMS Consulting Inc. implemented and validated the clinical trial data management system, based on Oracle Clinical and Oracle Remote Data Capture.
BioPharm Systems Inc., another Oracle Specialized Partner, helped DreamCIS to deploy and validate Oracle Thesaurus Management System. BioPharm Systems also provided DreamCIS staff members with training on Oracle Clinical, Oracle Remote Data Capture, and Oracle Thesaurus Management System.
“We were very pleased with the professionalism and quality of work of both partners,” said Ko. “Together, they worked to ensure the clinical data management platform met all our needs.”