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Clinical Research Software

Software built for
maternal & child
clinical research.

Materna Systems delivers federally compliant, purpose-built software for MNCH clinical research teams. Designed for rigor. Built with care.

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Active Studies
2,400+
Data Accuracy
99.8%
FDA / IRB Compliant
✓ Verified
21 CFR Part 11
HIPAA Certified
NIH Compatible
FedRAMP Ready
SOC 2 Type II
IRB Support
The Platform

Every tool your research team needs.

From participant enrollment to final data submission, Materna Systems handles the full lifecycle of federally funded MNCH clinical trials — without compromise.

140+
Research institutions served
18M
Patient records managed
99.9%
Uptime SLA guaranteed
0
Critical audit failures to date
◎
EDC & eCRF
Purpose-built electronic data capture with MNCH-specific form libraries and validation logic.
⊕
Enrollment Tracking
Manage participant eligibility, consent, and cohort tracking across multi-site studies.
⊞
Regulatory Reporting
Automated generation of NIH, FDA, and IRB-ready reports with full audit trails.
⊗
Adverse Event Module
Real-time AE capture and escalation workflows built to federal reporting standards.
Regulatory & Compliance

Built to meet every standard you answer to.

Federal clinical research doesn't allow for shortcuts. Materna Systems is designed from the ground up to satisfy the most demanding regulatory environments in healthcare research.

21 CFR Part 11
Electronic records & signatures
HIPAA / HITECH
Protected health information
ICH E6 GCP
Good clinical practice guidelines
FedRAMP Moderate
Federal cloud security baseline
SOC 2 Type II
Annual third-party audits
"
From the Field
Materna Systems gave us the infrastructure to run a 12-site newborn outcomes study without a single compliance incident. It's the first platform that genuinely understands the weight of this work.
Dr. Priya Nair, MD, MPH
Principal Investigator, Neonatal Outcomes Research Consortium