A never-ending tension in clinical trials exists between a client’s need for quick changes to a technical system – for example, an IRT (IWR/IVR) system in production -- and the vendor’s need for time. The axiomatic truth is this: the details of clinical trials are often fluid, with the need for changes commonplace. But Sponsors and CROs often get frustrated when vendors say ‘We can’t provide those modifications overnight!” And vendors get frustrated when Sponsors and CROs insist “Why the heck not?”
Here’s the reality:
- Many system configurations may be changed in a day, but programmatic changes require time. How much time depends not only on the complexity of the change but on the other variables involved with finalization, not all of which are in the vendor’s control. To wit:
- How long it takes the client to review and approve the updated specification documents the vendor will need to develop and provide for the change
- The time required for the vendor to adequately validate the system changes
- The time required for client review and testing of the changes
- Time for revision and finalization of all testing results
Issues of scope apply to all modification timelines. For example, let’s say that a protocol amendment allows the maximum age of a subject to be raised from 75 year to 80 years—but only for some clinical sites. For other sites, the 75 year limit remains.
Updating a system configuration to change the age limit of subjects in a study might be a one-day affair. But updating a system to permit different maximum ages for different sites – that is, allowing different sites to be using different versions of a protocol at the same time – is, understandably, a more complicated programmatic and specification issue.
Project managers on both the client and IRT sides of the aisle need to clearly define and address all of the variables that go into a given system change and collate those factors around a realistic -- and hopefully frustration-free – understanding of the update timeline.
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