Oracle Clinical RDC currently provides the only fully integrated solution on the market, where staff at doctors' offices and hospitals can use a Web interface to enter patient data directly into a complete clinical trials database.
The new release extends this capability by integrating Adobe Portable Document Format (PDF) forms technology, allowing the data to be collected in page layouts that are identical to the conventional paper forms. As each page of data is submitted, it is validated against Oracle Clinical Data Management system, and the user is notified immediately of any data problems. Problems can then be corrected quickly and electronically, with the system keeping a full audit trail of any changes, as required by the United States Food and Drug Administration (FDA) Code of Federal Regulations (CFR) Title 21 part 11.
The new release includes an integrated layout tool, so that the forms for data collection are designed once, regardless of whether the data is to be collected electronically, on paper, through batch load or any combination of the three. Historically each form had to be defined three times: once on paper, once for the clinical trials database and once for the RDC tool, so this new release offers tremendous advantages over the piecemeal solutions offered by other vendors.
Once a study is complete, the data may be converted to PDF, providing both a certified copy of the data for the doctor and a record of the source data for the eventual submission. This is a critical feature as all original clinical data must be included in regulatory submissions, and the FDA expects submissions in PDF.
"The primary reason that traditional RDC tools have not been more widely adopted is that they only automate part of the process", stated Keith Howells, Vice President of Oracle's Pharmaceutical Applications group. "The new release of Oracle Clinical RDC automates study design, data collection, data management and regulatory submissions, using an architecture that can scale to handle hundreds of studies per year. This will help our customers to bring medical products to market faster and at lower cost."
"Over the years, businesses have relied on the strengths of PDF for retaining document fidelity and security, strengths that have also helped the format gain broad adoption in the electronic forms market", stated Harry Vitelli, Vice President of Business Development, Adobe. "Adobe is pleased to be working with innovative leaders like Oracle and Pfizer to deliver PDF technology in such a critical application as bringing new drugs to market."
The RDC application includes the ability to design and deploy adobe PDF forms in Japanese, providing a familiar interface for users in Japan. The Japanese data can be translated back into English for analysis alongside other studies where the data was collected in English.