Automation of Out-of-Scope Trackers and CNFs?
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by Anca Copaescu
CEO, Strategikon Pharma

Clinical trial change tracking is notoriously difficult for Sponsors, especially when changes need to be rapidly approved and can’t take the time to go through an entire change order process. The Change Notification Forms, or “CNFs” have been around for several years with various degrees of standardization. Most CNFs track the specific change, the budget variance, the scope of the change, at activity and aggregate level. Most also have limits on how much work can be released based on the CNF alone, defining triggers for the single and cumulative CNF amounts that can be tolerated before processing a change order. Almost universally there is some approval mechanism, which is usually done by signing the CNF or via email approval.

The “out of scope” trackers, or CNFs would be fine to manage if it weren’t for the manual tracking aspects of the CNFs, especially at aggregate (portfolio) level. Having a few CRO change trackers may be OK, but what happens when you have dozens, hundreds? What if the changes do not include the impact on the trial costs or pass-through costs? How often is your finance team challenged with under or over-accruing? Regardless of the company size, it is frustrating for the study teams to be surprised by the change order amounts and timing, even if the ongoing changes were technically tracked in the CNF line-by-line.

Automating the CNF management with an embedded communication log, system change submission, revisions, approvals and role-based access that enables both study and finance teams to view tracked changes in real time, lies at the very foundation of Clinical Maestro LEAD.

Here is a sneak peak of a modern CNF in LEAD.

Small biopharma, large pharmaceutical sponsors and CROs all benefit from full transparency in the change notification process. This includes benefits such as: full traceability and significant workload reduction for the busy study and outsourcing teams. Additionally, it eases invoice reconciliation and expedites reports to support the accrual process. LEAD was co-designed by both Sponsors and CROs, so the system workflow naturally blends the unique processes of each. With increasing labor cuts and staff reductions, automation in such a labor-intensive process and increased transparency in change management is proving to be a win-win for all.