Controls that stand up to scrutiny.
Navigating public financing and IND filing requires enduring confidence in your controls — the kind that survives investor diligence and regulatory review. We build it, document it, and make it defensible.
Audit-ready IT controls
ITGCs applied efficiently, mapped to the financial statements auditors will actually test.
Filing-grade evidence
A completed IT checklist your investors and regulators can rely on.
Trial-ready practices
Policies that prevent the expensive delays that stall clinical programs.
An ISMS that holds
A right-sized information security management system, built to certify.
Insurable posture
Controls that answer the questionnaire and hold your renewal premium down.
Evidence, continuously
Controls that stay true between audits — not a scramble the week before.
Where we do the work.
Five moments where the state of your IT controls decides whether the business moves forward — or waits.
SOX-404B Readiness
As you approach public markets, IT general controls move from good practice to statutory requirement. We apply SOX-404B efficiently from the IT perspective — scoping the systems that touch financial reporting, standing up access, change and operations controls, and producing the evidence auditors expect without drowning your team in process.
- ITGC scoping & risk mapping
- Access, change & ops controls
- Evidence collection & walkthroughs
- Auditor coordination
IND Application
An Investigational New Drug application puts your systems and data integrity in front of regulators and investors at once. We deliver a completed IT checklist — the systems inventory, access governance, data-integrity and validation posture — so the technology side of the filing is a settled question rather than an open risk.
- Systems & data inventory
- Data-integrity controls
- Validation & qualification posture
- Investor-ready documentation
Clinical Trial Readiness
Trials fail their timelines for avoidable reasons — unmanaged access, unvalidated systems, gaps a monitor flags on day one. We put the policies and practices in place ahead of time so the technology never becomes the reason a site, a sponsor or a regulator hits pause.
- GCP-aligned IT policy
- System validation & access
- Vendor & eTMF governance
- Inspection preparedness
ISO 27001
A recognized information security management system that customers, partners and boards can trust. We build an ISMS sized to your organization — scope, risk assessment, Statement of Applicability and the operating rhythm behind it — and take you through to certification without the enterprise-scale bloat.
- Scope & risk assessment
- Statement of Applicability
- Controls implementation
- Certification & surveillance
Cyber Insurance Renewal
Insurers now underwrite on the strength of your controls, not just your revenue. We align your security posture to what carriers actually ask — MFA, EDR, backup, response planning — so the questionnaire is answered honestly, coverage is granted, and the premium reflects real, demonstrable maturity.
- Questionnaire readiness
- MFA, EDR & backup controls
- Incident response plan
- Evidence for underwriting
Diligence is a state you can be in.
Not a fire drill before each review. We keep your controls defensible between the milestones that matter.
Tell us what is coming — a raise, a filing, a renewal, an audit — and we will tell you where you stand.