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.
