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CLINICAL DATA MANAGEMENT

Support Clinical Research & Development functions with optimal processes, systems, and structure for capturing, processing, and reporting clinical and non-clinical study information

Clinical Data Management (CDM) is a critical component of Clinical Research, which includes data collection, data cleaning and review procedures to ensure data is Complete, Consistent, Enduring and Reproducible. Data Quality & Integrity is ensured by adopting ALCOA (Attributable, Legible, Contemporaneous, Original, Accurate) principles or framework. Capturing quality clinical trial data is the key to ensuring patient safety and confirming efficacy in clinical development today. Efficient systems, processes, and people help to produce a drastic reduction in time during Clinical Drug Development.

CLINICAL DRUG DEVELOPMENT PROCESS

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IKCON PHARMA  provides clinical data management services from case report form (CRF) design through database lock and archival. Assures quality using standard operating procedures, including the use of templates for standard CRF/eCRFs, data management plans, user acceptance testing procedures, data review checklists, database quality acceptance sampling plans and database lock plans. Our procedures includes Case Report Form (CRF) designing, CRF annotation, database designing, data-entry, data validation, discrepancy management, medical coding, data extraction, database locking, data archival.

 

Our team of data managers are committed to upholding a standardized, process-driven approach. They can deeply understand each clinical study, from database set-up to database lock. Our data managers are also familiar with other off-the-shelf EDC systems. Our list of services includes but not limited to:

 

  • Design Case Report Forms (CRFs) following industry standards

  • Database Development

    • Database Specifications

    • Edit Check Specifications

    • User Acceptance Testing (UAT) Plan

    • Data Validation Plan

    • User Administration, Training and Support

  • Data Management Plan & CRF Completion Guidelines

  • Data Cleaning & Review Procedures, Query Management

  • Data Integration from external sources

  • Medical Coding

  • Interim PK/PD Data Review

  • Serious Adverse Events (SAE)

  • Study Metrics, Key Performance Indicators (KPI), Key Risk Indicators (KRI)

  • Interim & Final Database Lock procedures

  • Data Archival & eTMF Management

  • On-shore and off-shore Clinical Data Management Services

  • Use of value-added technology to streamline Clinical Drug Development.

  • Ease Data Acquisition, Integration, Aggregation, Analysis and Reporting

  • Ensure that systems and processes are compliant, flexible, scalable, and sustainable.