What Kind of IT Infrastructure Does a Pre-IND Biotech Really Need?

If your biotech or pharma start-up is aiming to file its first IND within the next 6 to 12 months, you're probably swimming in scientific and regulatory priorities. It's tempting to treat IT as something to deal with "later"—but the truth is, your digital pre-IND infrastructure plays a quiet but critical role in IND readiness.

You don’t need a full-blown enterprise IT department. But you do need a few foundational tools in place—systems that ensure your data is secure, your documents are compliant, and your team can collaborate without chaos.

So what do you actually need from an IT standpoint before submitting your first IND?

Let’s break it down.

Pre-IND Infrastructure Need No. 1: A Document Management System That’s More Than a Shared Drive

You might be using Google Drive or Dropbox now—and that’s okay for a while. But as you start preparing for regulatory submissions, those shared folders can quickly become a liability. What you need:

• Version control (so you know what changed and when)

• Access controls (to ensure only authorized users can edit)

• Audit trails (to track activity for compliance purposes)

✅ Smart IT Move:

Start with a lightweight, GxP-friendly document management system (DMS). Options like Kivo or a configured SharePoint system offer compliance without overwhelming your team.

Pre-IND Infrastructure Need No. 2: FDA-Ready Secure Email

If you're not set up to communicate securely with the FDA, your submission process will hit a wall. The FDA doesn’t send IND acceptance letters via personal email accounts. What you need:

• A domain-based, secure email system

• Registration with the FDA’s Electronic Submissions Gateway (ESG)

• Encryption and backup capabilities

✅ Smart IT Move:

Get your FDA-compliant secure email infrastructure in place 4-6 weeks before you want to start interacting with FDA (see Appendix A of this CBER SOPP, which is the same process for CDER), and plan to get your ESG NextGen account setup at least a couple of months before you plan to submit your preIND package. It’s not just for the regulators—investors will also appreciate the signal that you're operationally ready.

Pre-IND Infrastructure Need No. 3: A Way to Track Who Touched What

When your documents become part of a regulatory submission, you’ll need to prove they haven’t been tampered with and were handled appropriately. That means audit trails, timestamps, and controlled access. What you need:

• System-level audit trails for key documents

• Role-based permissions

• SOPs to define how documents are handled

✅ Smart IT Move:

You don’t need expensive validation tools—just a system that can log document activity and basic SOPs to back it up.

Pre-IND Infrastructure Need No. 4: Data Storage That Meets Global Privacy Expectations

If you're handling any personal data (especially from EU-based advisors, trial participants, or consultants), you'll need systems that support GDPR and data privacy compliance. What you need:

• GDPR-compliant cloud storage

• Security features like encryption, MFA (multi-factor authentication), and user access logs

✅ Smart IT Move:

Look for cloud-based file storage that’s built with life sciences in mind. Bonus points if it supports geographic controls for international data privacy.

Pre-IND Infrastructure Need No. 5: A Scalable Way to Manage Vendors

As you bring in partners (like CROs or data vendors), you’ll need a place to manage contracts, contacts, and system access. What you need:

• A basic vendor management tracker (even a well-structured spreadsheet will do!)

• Clarity on who owns vendor onboarding and offboarding

• Systems access logs for third parties

✅ Smart IT Move:

Set up a simple vendor onboarding process and access review schedule—it’ll pay dividends in accountability and audit readiness.

The Bottom Line: Start Small, But Start Smart

You don’t need every bell and whistle to submit your IND. But you do need a solid foundation: secure communication, compliant document handling, and traceable data workflows.

These aren’t just regulatory requirements—they’re also the kind of operational maturity that gives investors confidence in your ability to scale.

At The Sugar Water Operations Team, we help early-stage life sciences teams build right-sized IT strategies that support your science, not slow it down. No unnecessary tools. No bloated systems. Just smart digital moves for lean teams.

📅 Ready to map out your IND IT essentials? Schedule a free consult and let’s build your digital foundation together.