Over the years we have been fortunate to work with our clients on projects big and small, across the entire drug R&D continuum, from early discovery to human trials, on three continents. Some projects involved extremely valuable (i.e. expensive to lose and therefore high-value) data. All projects were important to us and of course (as we always are told) all really useful data workflows must be low-maintenance. A holy grail of sorts.
So we set out in pursuit of this holy grail of high value and low maintenance. It is not a purely theoretical concept. We have in fact witnessed this rare confluence in our own work from time to time and we now strive to make it a frequent occurrence in our clinical research informatics practice. Let us try to crystallize the features that we think are prerequisites to high endurance in unattended data processing.
Conditions for Endurance
Let us start by looking at a couple of examples from large pharma.
In the first case, we got a phone call from informatics IT five years (half a decade!) after delivering a project. The client had in place a recurring automated workflow processing CRO data from multiple in-vivo studies over time. In that friendly call, after the customary how-are-you's we were informed that following an unrelated emergency server upgrade (this is a large pharma), their nightly animal study CRO data capture workflow stopped. Not failed but just refused to execute and left behind a lengthy error log. So we looked together at Saber Informatics admin documentation for the workflow (reader, make a note) and went tracing deployment steps one by one. It turned out that an open-source windows executable needed for one step in the data processing, was missing on the new server. We installed it, and the workflow was able to run again. Some of us at Saber Informatics got an unscheduled bonus in that week's paycheck! Unbelievable, this was still running after five years without active maintenance - we started to ask ourselves why.
In the second case, human clinical trial data in thousands of gnarly Excel files had been flowing in for automated processing from CROs over four years. In this time span there had been changes in the informatics IT department, restructuring, and new overseas IT partners were introduced to support informatics. The workflow kept humming along. It was when external IT partners started asking maintenance questions about the workflow, we also began to wonder - what made it to endure over the years?
Lessons Learned
Looking back, we think there are at least five characteristics that are shared by long-running data capture workflows. Each of these will contribute to make your unattended workflow a low-maintenance process.
- Subject matter experts are available at the outset - they know what matters. If you can get their input and iterate the design a couple of times, you will be golden.
- Stable infrastructure - if you know that your server will not be decommissioned in a year due to changing Windows versions, you can work with longer time horizons. You should register your server in the organizational IT resource inventory system to prevent someone from hitting "delete" on it without a very good reason.
- If the workflow is requested by the organization after a period of unmet need (a real need as opposed to just "an idea"), chances are it will endure if it meets that recognized need.
- It helps to have flexibility (backup branches) built-in to the workflow processing logic. Like bamboo, the algorithm will bend to accommodate variations in inputs.
- Scarcity of software resources can be a plus - people value systems that keep working. There probably is no off the shelf software for the task or Saber Informatics wouldn't be called in to help. For that reason, the workflow will have a unique advantage: it will genuinely fill an unmet need in the organization.
On a side note, outsourced informatics can be a plus because the new overseas partner would tend to accept an existing status quo and they won't push for a quick technology replacement, at least for a couple of years. This will help keep existing data workflows running undisturbed.
We Can Help
Feel free to call or email us at Saber Informatics to start a conversation: we bring to the table extensive practical experience in the field as an active practitioner. We honor strict client confidentiality and bring an industry insider perspective. We will listen and help.
