P&GP chose to pursue seamless and bi-directional integration. That is, we wanted data to flow in two directions: from the
electronic case report form (eCRF) to the CTMS and vice versa. We wanted a system designed to improve data reliability, to
enable managers to track progress, and to allow operational applications and analytical applications in various departments
to use the data. In theory, such data integration could be relatively straightforward. After all, the same data is used in
different departments across the company. Unfortunately, those different departments use IT systems from different vendors,
who in turn use a variety of incompatible data sources, applications and channels. Everyone may use the same data, but most
users are stuck with the data in their own system.
An Incremental Approach
P&GP took an incremental, evolutionary approach to data integration. One at a time, we added systems to the current integrated
network, assessed the results, and applied the lessons learned to the next integration. Each integration represented a landmark
on a road map sketched out in advance. Each step was planned to reach the next landmark. Moreover, each addition to the integrated
network is implemented first as a pilot project, and later as a full-scale implementation.
The company began by integrating Phase Forward's InForm™ EDC and ClinPhone's IVR system. In the first study, only a few data
points were integrated, mainly those dealing with demographics and randomization. After achieving this limited integration
and recognizing the benefits, P&GP added other elements into the mix, including IVR diary data. So far, integrated diary data
collection has only been used on two trials at P&GP, but the benefits were dramatic enough to make it a candidate for future
trials as well. The successful integration of these two systems from different vendors underscores that integration can work
as long as the vendor companies have the technology and personnel to support the venture. Effective integrations require an
active partnership between vendor and client.
P&GP discovered that a network resulting from even a modest integration offered benefits that exceeded the sum of its parts.
For example, patients registered in ClinPhone's IVR database were enrolled in InForm automatically. Within minutes, site personnel
were able to use the EDC system to enter clinical data. Moreover, patient diary data collected using ClinPhone's Patient Direct
automatically populated the eCRFs in the InForm system. This enabled real-time evaluation of diary data at each site. In addition
to showing mission-critical data, such as protocol adherence and recruitment, real-time evaluation helps monitors to identify
safety issues earlier than they could had they used non-integrated systems.
Patient screening and enrollment reveal additional benefits of EDC/IVR integration. Before the two systems were integrated,
site coordinators created a case book, which they populated with patient data. The integrated system uses IVR for screening
and enrollment. Now, by the time a site coordinator logs into InForm, IVR data has already populated the case books for newly
enrolled patients. The coordinator can begin data entry immediately. This reduces the workload on clinicians, who do not have
to transcribe diary data, calculate scores, or enter screening and demography information twice. The integrated platform enables
clinical trial sites to take full advantage of each solution's capabilities, while eliminating duplication. Furthermore, integration
reduces the length of our IVR calls, simplifies EDC entry, and allows investigators to view the data in real time. Moreover,
entering the data only once reduces the risk of discrepancies that can occur whenever the same piece of information is entered
into more than one system. The data management team must no longer look for—or query—discrepancies between two systems. Depending
on the number of patients enrolled, eliminating data discrepancies could save days of effort in each study.
When planning such integrations, P&GP built in quality controls to monitor the systems and take corrective actions. The company
worked at keeping the system architecture straightforward, avoiding needless complexities. For example, a "data ownership"
rule made certain that a data item originating in any given system could only be changed in that system and not in any other.
The change would then roll through to the integrated databases. Simple guidelines, such as the data-ownership rule, help simplify
procedures for troubleshooting the systems.