End-to-End Data Management

Specializing in Oncology, Women's Health, Medical Devices, and Rare Diseases — across Phase II–IV and non-interventional studies.

Study Build

CRF design and standards alignment
Edit checks and derivations
User roles and permissions
Database Specification Oversight

Conduct & Cleaning

Data review and reconciliation
Query Management and site communications
SAE/AE and lab data oversight
Quality control and audit prep

Close & Lock

UAT and go-live readiness
Freeze, snapshot, and lock
Listings and data exports
Inspection readiness support

Flexible Engagements

We collaborate closely with Sponsors and CRO partners. Whether you need targeted support or a fully managed function, we tailor our approach to your team.

GCP CRO Oversight SOP Author CDISC Aware

Compliance & Standards

Grounded in GCP and clinical data management best practices, with deep experience in CRO oversight and SOP development.

Frequently Asked Questions

Quick answers to common questions about how we work.

Which EDCs do you have experience in working with?

Medidata RAVE, Medrio, Fusion, Baseline Plus, Datafax, RedCap, Veeva, and Syncapture; however, we are adept at learning new database platforms and can train for any system.

Can you oversee a CRO on our behalf?

Yes. We provide CRO oversight with clear KPIs, quality gates, and inspection readiness, acting as an extension of your sponsor team.

Do you handle Phase II–IV and non-interventional studies?

Yes. Our team has 10+ years of experience delivering data management for Phase II–IV and non-interventional designs.

Let’s talk through your study

Share your goals and timelines — we’ll propose a clear plan.