Clinical Data
Management & EDC

Before a single form is built, we review your protocol and schedule of assessments to translate objectives into a clear data strategy.

Our team identifies critical data points, visit structures and derivations upfront so nothing is missed later.

Using Galax EDC, we design intuitive eCRFs that mirror site workflow, minimize free text and reduce ambiguity for investigators.

Each form is mapped to standards and downstream analysis needs, so your statisticians get exactly what they need. The result is a database that is easy to use at sites, robust for analysis and aligned with regulatory expectations from day one.

High-quality data comes from smart checks, not just more checks. We configure tiered edit checks and cross-form validations that focus on critical data and safety signals, avoiding unnecessary noise for sites.

Our team defines clear rules for allowed ranges, protocol windows, visit consistency, dosing logic and key endpoint derivations. We also help you design a risk-based SDV and review strategy that concentrates effort where it matters most.

All checks are version-controlled, tested in UAT and fully documented, providing a transparent audit trail for sponsors, CROs and inspectors

Once your study is live, our central data management team continuously monitors data flow across sites, visits and systems.

We track missingness, outliers and trends, and proactively raise queries on potential discrepancies before they impact analysis. Query text is written to be clear, courteous and actionable for site staff, reducing back-and-forth and resolution time.

Dashboards in Galax show open vs. resolved queries, site performance and aging, helping you identify where support is needed. This systematic approach shortens the data-cleaning phase and keeps your trial on track for timely database lock.

From the beginning, our EDC setup is aligned with CDISC standards to avoid painful remapping at the end of the study.

Variables, codelists and structures are designed with SDTM and ADaM in mind, including controlled terminology and derivation logic. We create clear mapping specifications that link each eCRF field to its final SDTM domain and variable.

Our programmers then implement and validate these mappings, using reproducible scripts and independent review. This standards-driven approach reduces rework, accelerates CSR timelines and increases the likelihood of smooth regulatory review and data sharing.

Accurate coding and consistent safety data are essential for reliable signal detection. We support MedDRA and WHO-Drug coding, applying sponsor-specific conventions while keeping a clean audit trail of decisions and change history.

Our team works closely with pharmacovigilance to reconcile AEs, SAEs, deaths and discontinuations between the clinical database and safety system. Regular reconciliation listings and review meetings ensure that no important event is missed or misclassified.

By tightening this link between CDM and PV, you gain confidence that safety profiles, narratives and regulatory reports are all based on a single, consistent source of truth.

As your study nears completion, we coordinate a structured data-cleaning and freeze process with all stakeholders. Outstanding queries, coding, reconciliations and protocol deviations are tracked to closure with clear ownership and timelines.

We prepare lock packages including data-management plans, issue logs, edit-check specifications and final status reports for inspection readiness. Once criteria are met, the database is locked in Galax with full traceability and controlled access.

Clean, standards-compliant datasets and documentation are then handed over to biostatistics and medical writing, supporting rapid TLF generation, CSR development and regulatory submission.