Data Management

We have comprehensive Clinical Data Management (CDM) Services
  • End-to-End CDM Services

    • From CRF design, database deployment - set up, and query management to Database Lock (DBL) — for both electronic (eCRF) and paper-based studies.

  • Robust IT Infrastructure

    • Ensures data security, privacy, and uninterrupted service delivery with well tested back up plans to address all contingencies.

  • Expertise in Leading CDM Systems

    • Proven experience with industry-renowned clinical data management platforms.

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  • Compliant Processes & Documentation

    • Well-defined SOPs, working procedures, and study-specific documents aligned with ICH-GCP, country & global regulations and guidelines.

  • Skilled Talent Pool

    • Experienced professionals with hands-on knowledge of Phase I–IV trials across diverse therapeutic areas, including Biologics and Biosimilars.

  • Stringent Quality Control Measures

    • Multi-level QC and independent QA reviews to ensure accuracy and compliance throughout study conduct, documentation and data processing.

  • High-Quality Data, Delivered on Time

    • Reliable, validated, and regulatory-compliant data output, ensuring efficiency and integrity in every study.

Extensive expertise from study start-up to database lock covering Initiation, Conduct & Closeout Phases.

CDM Tools

Data management team have experience of working on following various CDM tools:
  • Clinical Data Management Systems (CDMS):

    • Managing the entire data cycles, from capture to analysis and reporting.

  • Electronic Data Capture (EDC) systems:

    • Electronic data collection and storage, replacing traditional paper-based methods.

  • Clinical Trial Management Systems (CTMS):

    • Supports clinical trial process, including enrollment, randomization, and supply management.

  • Electronic Patient Reported Outcomes (ePRO) systems:

    • Enabling patients to record and submit their health outcomes electronically, providing real-time data collection.

  • Randomization and Trial Supply Management (RTSM) systems:

    • Manages patient randomization and the distribution of investigational products.

  • Interactive Response Technology (IRT):

    • Used for activities like patients enrollment, randomization, and drug dispensing.

  • Safety Gateway systems:

    • Manages and report adverse events.

  • Coding applications:

    • Standardizing the classification of medical terms, such as adverse events and medications.

  • Laboratory Data Integration systems:

    • Ensures the seamless transfer and management of lab data within the clinical trial database.