Companies providing IRT (IVRS/IWRS) systems that support clinical trials know they must be seen as being “flexible” in their approach to delivering those systems. Most IRT vendors claim a capacity for flexibility. But what does that actually mean…and how should one expect flexibility to impact cost and timelines?
At Veracity Logic, we prefer the simplest definition of flexibility: To be able to bend without breaking…anything (system, timeline, or budget)! This means vendor flexibility has to be offered in two arenas:
- Project Management (PM)
- System Design (SD)
But there’s also a third arena, much less talked about, in which a culture of flexibility is required for success: Client Engagement (CE)
Let’s consider each:
PM flexibility – what to look for:
- A true partnership attitude vs inklings of ‘us/them’
- Substance behind the hype. Good PMs know their job is two-sided: advocacy for the client, and advocacy for their company. It’s only constant effort to find a win-win that should…and does… bring the best results.
- A belief that creative, mutual problem solving is at the core of their job
- A naturally proactive communication style that lets the team always see what’s coming down the road
- Processes that operationalize quality enforcement without numbing bureaucracy
- A horizontal structure in a company: unlayered, nimble, and right-sized, and able to respond quickly to unforeseen events
- A culture that knows clinical trials = change, and that the project team’s job is find and apply best strategies to cope
- A commitment to staying ahead of the industry curve in the time required to fill change orders, in a company that lives on the most reasonable side of change costs
- PM oversight of an in-house help desk, able to reach true problem solvers at any time
System Design flexibility – what to look for:
- A design that allows users to minimize at will the need for help desk involvement for a wide variety of changes – for example, managing cohorts and cohort limits, turning a treatment group off based on findings without breaking randomization integrity (adaptive studies); modifying (and re-modifying) enrollment limits at the study, site, country level as project needs dictate; specifying multiple resupply processes within and across sites…to name but a few!
- A design strategy that accommodates protocol amendments, with a core that permits multiple versions to run concurrently by site
- A design that permits re-configuration of the production system in key domains by a simple method of pre-validated configuration imports
- A report strategy that enables users to easily create custom reports as needed
- Notification and user permission functions that are easily modified during the study
- And so on…
Client Engagement — what is most needed:
This is the third and perhaps most critical piece of the flexibility pie. In a win-win scenario, it’s incumbent on clients to recognize – and plan for – the fact that there is, of necessity, a symbiotic dance between fast/cost effective delivery of a clinical trial system and changes that are applied to that system.
Flexibility by client members of the project team includes:
- Distinguishing internally between functions that are ‘nice to have’ and those required to execute the project
- Advocating internally for straightforward processes that improve the speed at which project teams can accomplish milestones…for example, simplifying sponsor-side approval processes
- Recognizing that imposed ‘franchise’ processes logically may slow vendors down because of newness – and may also put quality in greater threat. Such changes should be applied selectively and collaboratively, as a win-win analysis by the project team
- Soliciting creative vendor input to problem solving. Remembering that no one wants a project team that acts as a ‘yes man.’ Not only is it boring…it’s dangerous!
- Helping to tweak components of schedules to accommodate changes that require unexpected system testing without blowing up final timelines
- Getting a leg up on possible in-study change costs by adding a 20-25% contingency line item to the client’s own internal project budget perspectives
The most important takeaway on the subject of flexibility is this: The best project teams work together – client and vendor – to operationalize flexibility in a way that balances change time, and cost and creates a true win-win for the project.
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