Errors plague transition to 'paperless' clinical trials, says Intrasphere
Company Announces New Electronic Data Capture Practice
Five major pitfalls await drug development executives attempting a paperless clinical trial environment, according to Intrasphere Technologies, which has created a new Electronic Data Capture (EDC) practice area to help pharmaceutical companies realize the benefits of EDC in managing clinical trials.
The company has identified the following most common mistakes that prevent drug companies from achieving the significant time and cost savings available by going paperless:
EDC Systems Are Not Fully Integrated
It is essential to integrate EDC technology with existing legacy and enterprise systems in order to facilitate and streamline downstream tasks such as data mining and cost analysis.
User Requirements Are Not Identified Early in the Process
Every EDC implementation touches a broad spectrum of stakeholders, each with different goals and expectations of what EDC can deliver. Key stakeholders must be identified early. Their needs must be used to help prioritize product functionality and features prior to its selection. This process also gets key players enrolled early, thus minimizing resistance to change.
Business Processes and Systems Are Not Thoroughly Mapped
By collecting and organizing the business and technology requirements of all people in the clinical trial enterprise, better decisions are made about specific technologies that will serve their needs. Additionally, a risk management plan, including risk profile, should be created.
Technology Solutions and Organization Are Mismatched
EDC technology and telecommunications approaches are rapidly evolving. The key to successful EDC implementation is finding the technology solution that fits best with the organization, and takes into consideration scalability and long-term technology plans.
EDC Solutions Providers Are Not Thoroughly Assessed
When selecting EDC solutions providers, pharmaceutical executives should have the following concerns: economic viability, pricing model, scalability, domain knowledge and regulatory awareness (i.e. 21 CFR Part 11). A knowledgeable and objective assessment of EDC solutions providers is mandatory.
Intrasphere EDC Practice
Intrasphere's new Electronic Data Capture practice provides a range of services that are based on the company's expertise in EDC products and solutions, information technology, and in the drug development process. These services include customized integration, application development, business process and systems mapping, vendor assessment, implementation strategy and development and deployment of eLearning tools.
The practice is headed by Susan Nonemaker, whose experience in EDC with clinical trials includes SmithKline Beecham's Clinical Research and Development division, Ibis Software, a company devoted to developing pen-based remote data entry technology and the Informatics division of Grey Healthcare Group. Additional information about Intrasphere's Electronic Data Capture Solutions is available by contacting Ms. Nonemaker, 212- 937-8287 or susan.nonemaker@intrasphere.com.
About Intrasphere Technologies
Intrasphere Technologies, Inc. provides technology solutions to companies seeking to maximize their Internet, Intranet and Extranet business space. The company specializes in application development and systems integration for the pharmaceutical and finance industries. Headquarters are at 100 Broadway, New York City, with a second office in London. The company maintains a Website at www.intrasphere.com.
Pursuing More Efficient Clinical Trials
Changes in the efficiencies of clinical trials are being widely sought within the pharmaceutical industry with the joint goal of reducing costs and speeding up time to submission. Approximately 85-90% of pilot studies are paper-based; a slow process requiring frequent data re-entry. This, in itself, leads to error, further slowing the process. Information is not easily organized and integrated so it can be used to guide critical decision-making. Until recently, pharmaceutical and biotechnology companies developed homegrown solutions or were limited to a small selection of specialized software. Within the past few years, numerous flexible options have become available, requiring informed decision-making in their selection.
Source: Intrasphere Technologies, Inc.
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