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When was the last time you searched through email threads to find an IIS approval status? If you're like most Medical Affairs professionals, it was probably this week. Maybe even today.
Email feels like a natural choice for managing investigator-initiated study approvals. It's universal, familiar, and creates a paper trail. Everyone uses it. Everyone understands it. Yet for all its convenience, email fundamentally fails as an infrastructure for life sciences workflows. The gap between what email provides and what IIS approvals demand creates risk that compounds with every forwarded attachment and every buried response.
The illusion of documentation
Email creates records, but not defensible ones. There's a critical distinction here that becomes painfully clear during regulatory inspections. When an FDA auditor asks for evidence of your IIS approval process, showing them, a folder of emails is like bringing receipts to a tax audit when they've asked for certified financial statements.
Consider what happens when an investigator submits an IIS concept. The initial email goes to a Medical Affairs coordinator, who forwards it to three reviewers with their own comments added. One reviewer replies all with feedback. Another sends a separate response just to the coordinator. The third downloads the attachment, marks it up, and sends back a renamed version. Two weeks later, someone asks, "Which version did we actually approve?"
Version control becomes impossible when attachments multiply across inboxes. You might have "IIS_Concept_v1.docx" in your sent folder, but somewhere in the thread, there's also "IIS_Concept_v1_ReviewerComments.docx" and "IIS_Concept_FINAL_v2.docx" and "IIS_Concept_FINAL_FINAL.docx." The actual approved version? It exists somewhere in this digital haystack, assuming everyone remembered to reply-all and nobody's comments got lost in a separate thread.
The ownership vacuum
When everyone's CC'd, no one truly owns the process. This diffusion of responsibility creates a peculiar organizational blindness. The concept sits in six inboxes, but whose job is it to chase that missing approval? Who escalates when a reviewer hasn't responded in a week? Who makes the call when feedback conflicts?
Email-based approvals create what I call "passive delays" — time lost not to active review but to uncertainty about process ownership. A reviewer assumes someone else is handling the regulatory compliance check. The Medical Affairs coordinator thinks the therapeutic area lead is managing the timeline. The therapeutic area lead believes the coordinator is tracking everything. Meanwhile, the IIS concept sits idle, not rejected but not progressing, trapped in the spaces between responsibilities.
The escalation problem compounds this ownership vacuum. When a critical reviewer doesn't respond, who has the authority to reassign the review? In email, escalation usually means adding more people to the CC line, which only spreads responsibility thinner. You end up with approval of threads that include twelve people, where nobody knows who's actually empowered to make decisions.
Life sciences-specific risks
The stakes in life sciences make email limitations particularly dangerous. FDA guidance documents outline explicit expectations for documented decision-making in clinical research. ICH E6(R3) Good Clinical Practice guidelines require systems that ensure the integrity, accuracy, and reliability of trial data and documentation. Email meets none of these requirements.
When regulators talk about an "audit trail," they mean a comprehensive record that captures who made what decision, when they made it, under what authority, and with what information available to them. They mean timestamps that can't be altered. They mean clear documentation of the review process from submission through approval. Email provides timestamps and text, but it doesn't provide context, authority, or immutability.
"We can pull the emails if needed" isn't audit readiness. It's audit hope. Hope that you can find the right messages. Hope that nobody deleted anything important. Hope that you can reconstruct the decision-making process from fragments scattered across multiple inboxes. Hope that the reconstructed narrative will satisfy a regulator who's looking for systematic compliance, not archaeological evidence of good intentions.
The distinction between personal productivity tools and validated systems matters here. Email was designed for communication, not for process management in regulated environments. Using it for IIS approvals is like using a spreadsheet for enterprise resource planning — it might work at small scale, but it creates risk that grows with every additional study, every new reviewer, and every regulatory change.
The path forward
Proper IIS approval infrastructure treats the approval process as what it is: a critical business workflow requiring standardized routing, clear ownership, version control, and defensible documentation. This isn't about replacing email communication. It's about recognizing that communication and process management require different tools.
Automated routing ensures concepts reach the right reviewers based on therapeutic area, budget, and scope. Version control maintains a single source of truth for documents throughout the review process. Clear ownership assignment eliminates the passive delays that kill momentum. Comprehensive audit trails satisfy regulatory requirements while providing operational insights.
The transformation from email to purpose-built infrastructure isn't just about compliance or efficiency. It's about recognizing that investigator-initiated studies deserve the same operational excellence we demand from sponsor-initiated trials. Every day an IIS concept sits in email limbo is a day lost in the pursuit of medical advancement.
Ready to move beyond email for IIS approvals? Explore how Approvia creates defensible documentation and streamlined workflows for investigator-initiated study concept reviews.
