The Hidden IT Risks That Can Derail Your First FDA Submission (and How to Avoid Them)

If you're a lean biotech or pharma start-up racing toward your first IND submission, you're probably laser-focused on the science. But here's a truth many early-stage companies learn the hard way: regulatory readiness isn’t just about data—it’s also about your digital infrastructure.

Missing or mismanaged IT elements can introduce costly delays, compromise your submission quality, and raise red flags with both regulators and investors.

Here are five hidden IT risks that can trip up your FDA submission—and smart, scalable moves to avoid them.

Hidden IT Risk 1. No Audit Trail = No Trust

Regulators expect to see who touched what, when—and why. If your document management system lacks audit trails, version control, or user permissions, you may not be able to prove your data integrity.

✅ Smart IT Move:

Start with a GxP-friendly document management system (DMS), even if it’s basic. Cloud-based tools like Veeva, Kivo, or even Part 11–compliant SharePoint configurations can scale with you without opting for higher-cost platforms. Consider scaled managed services or fractional shared resources to support day-to-day operational support of your cloud-based tools.

Hidden IT Risk 2. The “Secure Email” Gap

You may be using Gmail or Outlook today, but without encryption, secure email setup with FDA, and FDA-compliant configurations (like the FDA’s ESG), you're not ready to send and receive regulatory correspondence.

✅ Smart IT Move:

Plan ahead for FDA secure communication setup at least 3–6 months before your IND by identifying a service provider you can partner with early to set up and/or manage your secure communications. Not only does this avoid delays, it reassures investors/stakeholders that you're anticipating regulatory touchpoints.

Hidden IT Risk 3. “We’ll Worry About That Later” Data Strategy

Spreadsheets might work now, but poor data management becomes a liability as you transition to clinical operations. No structure for metadata, no governance model, and no system for storing raw and processed data? That’s a problem.

✅ Smart IT Move:

Begin with a lightweight data governance plan that aligns with FAIR principles (Findable, Accessible, Interoperable, Reusable). Even a basic framework shows investors/stakeholders, and regulators that your house is in order.

Hidden IT Risk 4. Unclear Roles = IT Chaos

In lean teams, tech often falls to “whoever is available.” That’s risky. When it’s unclear who owns IT policy, vendor management, or compliance documentation, balls get dropped and things get lost—sometimes critically.

✅ Smart IT Move:

Consider onboarding fractional IT leadership early. Whether it's a consultant or advisor, having someone responsible for digital readiness strategies keeps you moving forward with purpose—and frees up your scientific team to focus on science.

Hidden IT Risk 5. Overlooking Disaster Recovery

A power outage, system failure, or ransomware attack may sound unlikely—until it isn’t. Without a basic Disaster Recovery and Business Continuity Plan (BCP), your submission timelines (and funding) could be jeopardized – especially if your early development company documents are on a personal laptop that only one person can access or, worse yet, lose.

✅ Smart IT Move:

Right-size your disaster planning. You don’t need a full-scale BCP at seed stage, but you do need secure backups, access logs, and restoration protocols for critical systems.

Why It Matters to Investors and Stakeholders

Smart IT decisions aren’t just about compliance—they’re about confidence. Investors want to know you can scale, meet milestones, and respond to regulatory scrutiny without scrambling.

By building foundational systems early, you show investors that your team is proactive, efficient, and ready for the long game.

Final Thoughts

Your IND may be 6–12 months away, but your IT readiness needs to start now. These risks can be solved with scalable, strategic planning—no need for a massive overhaul or expensive tech stack.

At The Sugar Water Operations Team, we specialize in right-size solutions for small and start-up biotechs. And one of the things we’ve learned from our clients since our own launch is that there’s a need for lean, biotech-friendly IT operations strategy. So whether you need help building your roadmap, selecting the right vendors, or avoiding common pitfalls, we’re here to help.

📩 Want to talk about your IND readiness? Let’s schedule a 30-minute consult to assess your technology and digital capability gaps.