So You Have to Move off dsNavigator: How-to Advice on Switching Your Coding Tool
Oct 06, 2016
By Richard Jenkins
With about a quarter of the life sciences market believed to be using Cerner’s dsNavigator coding tool, the decision to pull the solution from the market raises understandable concern and many questions about what the priorities should be when seeking a replacement.
As I discussed in my recent blog, having a coding tool is essential for meeting compliance requirements. Hence, companies using dsNavigator will need to transition to another tool – and sooner rather than later. Already reports of functional gaps in the DSNavigator tool that won’t be addressed are cropping up.
There are other issues to consider that have substantial implications. For example, any updates to the MedDRA (Medical Dictionary for Regulatory Activities) hierarchy itself will not be reflected in the tool as Cerner is not doing any further updates. Nor will Cerner support integration with any new systems.
Before selecting a replacement tool, companies should take advantage of the transition period to ask some pertinent questions.
Life sciences companies may use a number of dictionaries, so it’s important that your tool handles dictionary version management and can manage multiple dictionaries, including maintaining a synonym list for each dictionary. The ability to migrate your synonym list may be another priority, and since this can be time-consuming, you need to know that your tool – and vendor – can adapt to your needs.
An important capability for a coding tool is automation, specifically as it applies to auto-coding against the synonym list or against the dictionary. Can the tool perform advanced coding algorithms and review synonyms before they are added to the synonym list?
To Integrate or Not to Integrate
A key question in selecting a coding tool is, will it be used as a standalone or integrated tool? If the latter, you’ll need to decide with which systems you want to integrate your coding tool. Is it safety, is it clinical data management systems, or both? Then you need to decide how that integration will happen. That’s a technical issue that will depend on your web service. Some companies use Simple Object Access Protocol (SOAP) web services and others use Representational State Transfer (REST) web services. You would want to know that your vendor is able to modify the web services to integrate with your SOAP or REST web service.
Careful planning needs to go into the technical details of integrating what data gets passed back and forth: is it just a coded term, is it the hierarchy, is it other general attributes such as indication, or study-specific data points coming from a data management system? What other terms and attributes are being brought in? You also need to consider whether you’ll be using multiple versions of MedDRA, and if you’ll require multiple versions to be loaded and context-specified for a particular study.
Emphasis on Partnership
When you’re moving to a new tool, it’s important to know whether your vendor will listen to what you need and will adapt as your needs grow and evolve. Will they modify their roadmap to respond to client needs, market needs, compliance developments, and so on? Does your provider have ongoing communities of interest (user groups, for example) with their clients to solicit input?
What is the level of involvement of the tool developer? For example, if they outsource implementation to a third party, how much support can you expect to receive if issues arise?
Preparing to Switch
With a switch from dsNavigator a fast-approaching requirement, now is the time to have a clear idea of what you want and need from your coding tool.
Having a good coding tool to address priorities such as automation – flagging instances where there is no match between a reported event and the synonym list – and potential inconsistencies with MedDRA updates are just some key considerations, along with ensuring a trusted partnership.
Learn more about priorities around coding by downloading the white paper, Achieving Consistency in Clinical Coding for Periodic Reporting and Signal Detection.