Data Management

Data Management

Accurate, high-quality data is the foundation of successful clinical trials. At Globyz Clinical, our Data Management services ensure regulatory-compliant, reliable, and analysis-ready data from study startup to database lock. Leveraging advanced EDC systems, rigorous quality checks, and industry expertise, we streamline data collection, integration, and validation to minimize risks and delays. Whether designing eCRFs, reconciling external data, or securing a clean database lock, we deliver efficient, scalable solutions tailored to your trial’s needs. Partner with us to transform complex data into actionable insights faster, smarter, and submission ready.

Our Comprehensive Data Management Services:

Our Comprehensive Data Management Services:

  1. Data Management Plan (DMP) Development

We create and maintain a detailed, study-specific DMP that defines data collection standards, quality metrics, and workflows—ensuring alignment with protocol requirements and regulatory guidelines.

  1. Database Build & Validation

  • Custom database design with robust edit checks and audit trails.

  • Full validation (UAT, IQ/OQ) to ensure system reliability and compliance.

  1. Electronic Data Capture (EDC) Implementation

  • Selection, setup, and validation of leading EDC systems (e.g., Medidata Rave, Veeva, Oracle Clinical).

  • Training and support for sites and sponsors to ensure seamless adoption.

  1. Source Data Verification (SDV)

  • 100% or risk-based SDV strategies to verify data against original source documents.

  • Centralized monitoring tools to prioritize high-impact discrepancies.

  1. Data Integration & Reconciliation

  • Seamless merging of external data (labs, safety reports, IRT) with EDC datasets.

  • Automated reconciliation to resolve inconsistencies efficiently.

  1. Database Lock & Delivery

  • Final QC, query resolution, and audit trails for a clean, analysis-ready database.

  • Secure transfer in preferred formats (SAS, CDISC SDTM, etc.) for biostatistics or

    regulatory submissions.

  1. Case Report Form (CRF) Design

  • Paper or eCRF development optimized for user-friendly data entry and protocol adherence.

  • Edit checks and skip logic to reduce queries and enhance accuracy.

  1. Electronic Data Capture (EDC) Implementation

  • Selection, setup, and validation of leading EDC systems (e.g., Medidata Rave, Veeva, Oracle Clinical).

  • Training and support for sites and sponsors to ensure seamless adoption.

  1. Database Build & Validation

  • Custom database design with robust edit checks and audit trails.

  • Full validation (UAT, IQ/OQ) to ensure system reliability and compliance.

  1. Source Data Verification (SDV)

  • 100% or risk-based SDV strategies to verify data against original source documents.

  • Centralized monitoring tools to prioritize high-impact discrepancies.

  1. Data Integration & Reconciliation

  • Seamless merging of external data (labs, safety reports, IRT) with EDC datasets.

  • Automated reconciliation to resolve inconsistencies efficiently.

  1. Database Lock & Delivery

  • Final QC, query resolution, and audit trails for a clean, analysis-ready database.

  • Secure transfer in preferred formats (SAS, CDISC SDTM, etc.) for biostatistics or

    regulatory submissions.

The Globyz Clinical Advantage:

  • Dedicated Team: Experienced data managers, programmers, and QA specialists.

  • Transparency: Real-time dashboards and proactive communication.

  • Scalability: Support for Phase I-IV trials, rare diseases, and complex study designs.

Contact us to discuss how we can optimize your trial’s data strategy—faster, cleaner,and submission-ready.