DreamCIS Cuts Time for Clinical Data Search by 99%, Trims Costs by 66%, and Boosts International Partner Collaboration on Global Clinical Trials
 
 

DreamCIS Cuts Time for Clinical Data Search by 99%, Trims Costs by 66%, and Boosts International Partner Collaboration on Global Clinical Trials

  • Oracle Customer:  DreamCIS
    Location:  Seoul, Korea
    Industry:  Life Sciences
    Employees:  249
    Annual Revenue:  Under $100 Million

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.

 
Building a Global Platform for International Clinical Trials

A word from DreamCIS

  • “We implemented Oracle’s health sciences solutions to effectively manage clinical trial data and meet global quality standards. We have reduced the cost of clinical trial data searches by 66%, cut search time from 7.4 seconds to 0.063 seconds, and can easily collaborate with international partners.” – Ko Hee-jung, Director, Biometrics Center, DreamCIS

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.

 
Improved Data Reliability and Monitored Clinical Trial Status in Real Time

 
Reduced Data Search Time by 99% and Costs by 66%

 
Enabling International Collaboration

 
Meeting Global Standards in Clinical Trial Data Services

 
Setting an Example for Korean CROs

 
 

 
 

Challenges

  • Replace an outdated legacy system with a Web-based management platform that can effectively manage the quality and integrity of international clinical trial data
  • Support increasing presence and reputation in the global CRO market by facilitating collaboration with international medical and pharmaceutical partners
  • Provide clinical trial services that follow International Conference on Harmonization’s good clinical practice guidelines, as well as the local country laws and conditions
  • Reduce the cost and time associated with clinical trial data searches
  • Ensure clinical trial data uses globally accepted medical terminology

Solutions

  • Cut clinical trial data search time by 99%, from 7.4 seconds to 0.063 seconds
  • Reduced the cost of clinical trial data searches by 66%, from US$8 per search to US$3
  • Monitored the status of clinical trials in real time and validated the accuracy of source documents throughout the trial, which wasn’t possible previously
  • Enhanced customer satisfaction and improved competitiveness by providing clinical trial services that meet international standards
  • Used the system to managed more than 60% of client projects two years after implementation
  • Improved the utilization rate of clinical studies by using a clinical data management platform that can capture and manage data based on global standards
  • Prevented data loss by keeping the source information intact even as it is being processed
  • Provided access to clinical data regardless of different document formats and electronic data capture methods used by global pharmaceutical partners
  • Achieved more cost-efficient global clinical studies by carrying out joint research with collaborating bodies internationally
  • Improved work efficiency by conducting a single clinical trial simultaneously from various locations overseas, and facilitating Web-based communication with international partners
  • Supported multinational clinical trials by implementing a centralized repository of globally used medical terms that accommodates diverse clinical regulations and which can be easily expanded
  • Increased the productivity of IT staff members and enhanced system performance, by using table partitioning to improve the efficiency of database and system management
  • Set the example for other Korean CROS on how to be compliant with domestic and international regulations and conditions
  • Laid the foundation to become Asia’s top CRO and a leader in international clinical standards by 2019

Why Oracle

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.

Implementation Process

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.

Partner

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.”