Where's the Trial Data

When we last spoke with Peg Regan, president and CEO of PharmaPros, she was discussing the software as a service (SaaS) aspect of data integration within clinical trials. Specifically, the application of PharmaPros' Electronic Data Lifecycle Management (eDLM) approach—a methodology for managing data holistically across a study.

Peg Regan, president and CEO of PharmaPros, is redefining eDLM.

PharmaPros has now taken the next step in addressing what it has termed eDLM by offering Dataflow Manager, launched last month. Dataflow Manager, in the product materials, is described as a comprehensive clinical data tracking and integration framework, with the core function of providing context-aware intelligence of electronic data related to a clinical trial, based on the defined study protocol. What it is in context is a decision support technology leveraging operational intelligence across various disparate source data systems used in conjunction with PharmaPros eDLM based services.

The Dataflow Manager product, said Regan, is "offering all the knowledge of our company."

With all that internal brain power captured and eDLM defined, Regan and the PharmaPros team are now left with establishing the education and vocabulary around eDLM. "Coming up with the right vocabulary around eDLM is challenging," said Regan. "This is a new concept, a level of data intelligence that hasn't been accessible before."

The data intelligence that is currently being left to squander is a result of the data integration issues that Dataflow Manager addresses. Specifically, the increasing number of data sources incoming to the sponsor and how data is stored in vertical data warehouses or silos. Data sources include EDC, ePRO, IVRS, CTMS, and lab data—all from differing vendors, using different software and processes.

"There is a need for the sponsor to stay on top of the trial and the data and to respond to issues proactively," explained Regan. "In a holistic manner, where are we in the trial?" Because of the proliferation of technologies, there is a lack of visibility into the overall progress of a trial. If the trial were viewed as a whole, there would be more value to all the constituents conducting the trial. The ability to view data holistically could positively impact many aspects of clinical trials, including adaptive trial design, milestones, and safety signaling throughout the trial. "However, it is nearly impossible to do that until all the data is put back together," said Regan, which is the current state of affairs.

For William Tobin, president of Norwalk, CT-based International HealthCare (IHC), a full-service CRO with about half of its employees in data monitoring, using eDLM has changed the way they view and use data. Previously, the staff relied solely on its proprietary Excel-based system. In 2003, Tobin discussed with PharmaPros the ways they could use additional tools for data flow. The outcome was an eDLM solution that featured the continued use of the Excel proprietary system but with a more dynamic integrated database.

"The big thing that we're using in our system is tracking our monitoring visits," said Tobin. "But we didn't have a data snapshot of how many subject visits we should have each visit. With Dataflow Manager, the monitors know more of what is expected from their site visits." Translated, it means instead of the client mandating a routine every eight week site visit, IHC can look to the Dataflow Manager to determine when the site will have collected most of the data and the most optimum time to visit the site. "It has reduced travel by at least 100 visits," related Tobin, and increased efficiency by 20% to 30%.

Elizabeth LaFrance, project manager of clinical operations for Tempe, AZ-based biotech OrthoLogic Corp., told Applied Clinical Trials, "You can use Excel spreadsheets, but it won't give you the knowledge that you can get from this holistic view." Using an earlier version of Dataflow Manager in a rescue trial, LaFrance was able to track visits, CRF forms, and know what was expected and what was delivered from each site.

"When we reach Phase II with our current drug, there will be samples, photos, IWRS, and information from multiple vendors that we will be able to pull in one place and manage proactively," said LaFrance. And, that is what Regan means when she says that the data holds the intelligence of the trial.—Lisa Henderson