Data Management & Biostatistics

Turning your study data into reliable evidence for regulatory and commercial success.

Data You Can Trust, Insights You Can Use

High-quality clinical research depends on high-quality data. At SAON, we bring together expert data management, statistical rigor, and integrated systems to ensure your study results are accurate, compliant, and submission-ready. Whether you are a MedTech sponsor or a CRO executing on their behalf, our Clinical Affairs team provides the infrastructure and insight needed to transform raw data into actionable evidence.

We do more than collect and clean. We design with the end in mind, aligning data capture and analysis with your study endpoints, regulatory requirements, and go-to-market strategy.

Our Support Includes

EDC and Data Infrastructure Setup

We customize and manage the study’s electronic data capture (EDC) system, ensuring that data fields, logic checks, and workflows support clean and efficient data collection. Our systems are intuitive, audit-ready, and designed to support accurate, real-time data capture and monitoring across all study phases.

Data Management Planning and Oversight

From CRF development to data validation and query resolution, we manage the full data lifecycle. Our team develops and executes comprehensive data management plans tailored to your protocol, while maintaining alignment with regulatory and sponsor expectations.

Real-Time Data Review and Reporting

We provide continuous data review, cleaning, and reconciliation throughout the study. This allows for faster interim analyses, early issue detection, and confident decision-making as your study progresses.

Biostatistical Analysis and Planning

Our experienced biostatisticians collaborate early to develop statistical analysis plans (SAPs) that match your study design and objectives. We handle everything from sample size calculations and randomization schemes to final statistical analysis and reporting.

Submission-Ready Deliverables

Whether for an IDE, PMA, 510(k), or post-market evidence package, SAON prepares all required data tables, figures, and listings. We ensure formatting, documentation, and validation meet current regulatory standards.

Why It Matters

Clean, well-organized data is critical not only for regulatory approval but also for gaining market traction. Sponsors and CROs need a partner that treats data as an asset, not an afterthought. SAON ensures your study data supports your story and your success.

Our Commitment to You

• Aligned from the Start. We design data systems and plans that fit your study protocol and objectives.
• Full Visibility. You get real-time access to data metrics, issue tracking, and performance dashboards.
• Statistical Expertise. Our team brings years of experience in medical device study design and regulatory submissions.
• Efficient Closeout. We streamline database lock and final analysis so your team can move forward with confidence.

Make Every Data Point Count

Schedule a call with our team to learn how SAON can support your study with expert data management and biostatistics.