We’ve been surprised over the past year or so by the number of IRT companies that have begun touting AGILE methodology as the knight-on-a-white-horse come to save us all from our clinical trial timing dilemmas. Oh, if only it were that simple!
A Decade of Agility
Veracity Logic has been using an AGILE-style methodology for nearly 10 years now. What we have learned is this: In its cleanest form, the approach does allow project teams to implement systems faster than with the traditional waterfall. But -- unfortunately for all of us – an AGILE process is not what finally makes a difference in the timelines of a project.
What it takes to impact timelines is a laser-focused project team. If we had to pick only one variable that makes the key difference in project timelines, this is our hands-down choice. We’ve been able to put an IRT system into production in as little as five business days with this kind of commitment from our clients. (It’s a given that the vendor also has to make this commitment!)
To achieve this feat, we had the project team (client and vendor) allocate the time to sit down together and work through the User Requirements Specification (URS) in only one day. It took us two days to develop the system and walk through an informal build. One day more for us to complete our internal system validation, and then one final day for client user acceptance testing.
Exception Not the Rule
But alas, this kind of team focus – with or without AGILE-style processes – is the exception, not the rule. Client teams typically average 1-2 weeks to finalize a URS, with the worst case we’ve encountered being more than two months. User acceptance testing averages 3-5 days with another factor-10 variation! In all of these scenarios, the same AGILE-style methodology on the part of the IRT vendor was being followed.
Our point here is not to offend Sponsors or to dismiss AGILE methods – merely to bring to the forefront the single ‘devotion’ variable that makes timelines hum. The list of real-life variables that can delay a clinical trial is long and complex and can derive from multiple arenas -- scientific, regulatory, logistical, etc. But once the unavoidable “external” factors are dealt with, it’s the project team’s turn to shine. And that’s where the rubber hits the road. Forming the client team and the IRT team into one cohesive unit with the same focused insistence on spit-spot performance, turnaround, and production is the difference between stellar and ordinary results – not AGILE in and of itself, nor any other single methodology. And anyone who tells you different may be trying to sell you something.
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