The Benefits of EDC Realized

Applied Clinical Trials

Supplements-03-02-2009, Volume 0, Issue 0

Designing and adapting the latest technology to meet clinical trial needs and redeem the best of its multiple benefits.

In any CRO, the choice of an EDC tool is a combination of meeting the CRO's needs and adapting to sponsor requests. There are many EDC products that sponsors prefer to use in trials. There are EDC products that CROs have acquired to promote as their own to broaden their capabilities. What it comes down to for PPD, one of the larger publicly traded CROs, is flexibility.

"We work with large, diverse pharmaceutical, medical device, and biotechnology companies," explained Jim Streeter, executive director, EDC, for PPD. "Some have their own EDC preferences like Oracle Clinical (OC) RDC Onsite, Phase Forward's Inform, or Medidata's Rave, and PPD offers these solutions to ensure flexibility for our clients.

While we have the capabilities and processes to work with any EDC vendor in the market, Oracle RDC Onsite is our preferred EDC system. It is hosted internally and used for a large portion of our EDC trials. When a client doesn't have an EDC preference, OC RDC Onsite is the system we use."

To date, PPD has performed over 200 clinical trials using EDC, with over 125 using Oracle's RDC system. "PPD has used EDC in clinical trials for over six years and the Oracle RDC product for almost four years," said Streeter.

Upgrading to Oracle's latest version—OC RDC Onsite 4.5.3—was a decision made easier by a number of factors: the look and feel of OC RDC and its Web-based interface; integrated discrepancy management; and performance and stability. PPD also uses the Siebel Clinical (now Oracle) CTMS system and Oracle's AERs.

PPD looked at Oracle's future integration strategy and vision strategy to ensure that its current and future products are integrated. "This future integration of Oracle products was important to PPD," said Streeter.

Smooth transition

PPD was the first company to upgrade to the new version of OC RDC Onsite 4.5.3 and is now the largest user of it. It has deployed RDC Onsite 4.5.3 to over 8000 global users and over 30 active studies since last March. PPD is an Oracle Strategic Development Partner—one of four to take part in testing and beta testing the new version.

"We were involved from the beginning in the development of the product, including requirements, design, and testing phases of the system development. In addition, some of our investigator sites were involved in usability testing, and they could look at the screens and offer input into the design," said Streeter.

By being part of the beta testing, PPD knew what to expect and could plan activities and training for a successful roll out to PPD investigator sites and users. Thus, it was able to migrate investigators quickly to the upgraded system and provide on-line training with no interruption to protocol activities at investigator sites. These sites were excited to upgrade to the new version and adapted to it very fast.

For the PPD technology department, RDC Onsite 4.5.3 was a "true" Web-based system, and it (and PPD's sponsors) reaped the benefits of not having to install plug-ins, products, or other interfaces onto thousands of users' computer systems. In addition, there was a 30% drop in support calls and a reduction in time to resolve them, resulting in time savings for investigator sites and clinical research associates (CRAs) who call the support center.

Pivotal additions

A key to PPD's use of Oracle's RDC Onsite is that electronic case report forms (eCRFs) can be set up to look and feel like paper CRFs.

The new version includes features key to investigator sites. CRAs like special page views for recording adverse events in addition to key log pages and the ability to work on multiple eCRF pages.

The change to the discrepancy management system provided a new eCRF integrated discrepancy feature, allowing investigator sites and CRAs side-by-side review of data and discrepancies, thus saving time.

Pleasing results

At PPD headquarters, the upgrade to OC RDC Onsite 4.5.3 was consistent with its overall strategy to make investigator sites successful with their clinical trial data acquisition and reporting by providing rapid data collection with an application that is intuitive and easy to use. This product also allowed PPD teams and its sponsors to integrate with other data sources (e.g., IVR and central labs) and provide needed reports for rapid review of progress and on-time reviews for safety and other business decisions.

For the CRO, the results were equally satisfying. If time is money, which it is, then success speaks for itself. Using the new OC RDC Onsite system, PPD has been able to have data cleaned in real time for optimal interim trial decisions and to have it fully finalized within 10 days after the last subject visit.

"Our sponsors and investigators have been very pleased with our approach and tools," said Streeter. The benefits of technology...realized.

Lisa Henderson is Editor-in-Chief of Applied Clinical Trials, email: lhenderson@advanstar.com