When integrating an IRT (IWR/IVR) system with an EDC platform, avoid collecting CRF data in the IRT. Optimal goals for deploying an IRT are to screen subjects (i.e., assign a Subject ID), to randomize subjects to a treatment group, and to assign drug to subjects during the trial. We recommend our clients follow a ‘must have’ approach for data collected in the IRT and subsequently pushed to the EDC – in most cases, limiting the data transferred to the Subject ID, Visit ID, and IP assigned.
One of the questions most frequently asked by clients during demos of the Veracity Logic IRT (IVR/IWR) system is how best to handle the problem of having to reconcile data between a study’s IRT and EDC platforms.
The answer is twofold, but simple: First, move data between the two systems in only one direction. Second, set up your study so you don’t duplicate data in the two systems.
Electronic integration between the IRT and the EDC systems should be a one-way arrow – ideally, data should be ‘pushed’ from the IRT to the EDC. Not only is this cheaper than requiring a two-way transfer of data (i.e., also ‘pulling’ from the EDC into the IRT, which can double costs), but, depending on the EDC platform being used, it may also be technologically simpler, since EDC APIs to receive data may be more available than APIs to push data.
Your EDC system will house the bulk of your clinical data for the upcoming clinical trial but you’re using an IRT for screening, randomization, and drug assignment. What’s the most efficient, cost-effective way to accomplish two key study goals: to integrate certain data as needed (in a timely fashion), and to avoid time-wasting duplication and reconciliation requirements between systems?
Through Integration of Medrio and Veracity Logic, Atlantic Research Group Expands Capabilities
Finding themselves under a strict timeline and in need of drug supply management, Atlantic Research Group was searching for a way to bolster their software repertoire. Using a free API from Medrio, they were able to access the comprehensive drug supply management capabilities of Veracity Logic without forfeiting Medrio’s top-shelf electronic data capture.
With the cost of executing clinical trials continuing to spiral upward, Sponsor and CROs are increasingly relying on the ability to integrate multiple service providers on a single study. Integration…true integration, that is…must accomplish three key procedural (and thereby cost) savings regardless of the types of applications/tools being integrated:
First, the integration must eliminate costly and inefficient redundancies, and the reconciliation activities they inevitably engender. Second, data sharing between systems must occur in close to real-time in order to avoid misinformation and the wasteful time/cost consequences misinformation can generate. Third, integration must be able to be accomplished easily and flexibly, without causing long delays in startup timelines and, hence, negatively impacting project budgets. Fourth, the integration must be reliable–that is, users must be able to feel confident that data is accurately and consistently being conveyed.
Veracity Logic’s approach to integrations between its IRT system and leading EDC platforms in the field today meet all four of these critical criteria. Data initiated by the IRT — for example, screening IDs or patient randomization data — are shuttled on a real-time, transactional basis to the EDC system. There is no need to enter the same data twice, thus eliminating the need for reconciliation. Error monitoring and correction processes are built into the our approach to integration, enabling users to feel confident in the status of the integrated database. For example, should a transmission fail– either on the IRT or the EDC side of things — an email is automatically sent to IRT staff who can then take the necessary steps to address the issue and retransmit the file.
Want to hear more?
Your study depends on reliable interaction between your IRT system and your EDC platform. But your current IRT provider has three times failed to successfully complete a transmission between the two systems…with no warning to you! In all three cases, the transmission error was caused by technical issues that were not in the IRT vendor’s control. Still, you need a way to solve the problem…fast!
Veracity Logic’s approach to third-party integration builds in error monitoring and correction processes. XML transmissions successfully completed are held in a SENT folder on the IRT server. Should the IRT server be unable to successfully transmit a document, that file will be moved into an Error folder and an email message automatically sent to IRT staff who can then take the necessary steps to address the issue and retransmit the file. If a snag at the EDC end is preventing data from being received, an email message is sent to VL’s staff so that resubmission steps can be taken.
At Veracity Logic, we know what real life is like, and we plan for it. Want more information or a demo of our system?