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Data Management

Providing secure and reliable data management service

Data on a Touch Pad

Our team of Clinical Data Management (CDM) is actively involved in all stages of clinical trials right from inception to completion of database lock and archival. We will work with you based on your timeline and budget to identify 21 CFR part 11-compliant systems to ensure accuracy, reliability, and consistency of data. We perform secure, computer-generated, time-stamped audit trails to indepedently record the date and time of operator entries and actions that create, modify, or delete electronic records. Our Standard Operating Procedures and controls will be implemented to ensure the integrity, authenticity, and confidentiality of data. 

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Our data management solutions may include:​

  • The protocol is reviewed from a database designing perspective for clarity and consistency.

  • A Case Report Form (CRF) is designed by the CDM team to translate the protocol-specific activities into data being generated.

  • The data fields should be clearly defined and be consistent throughout.

  • The type of data to be entered should be evident from the CRF.

  • The CRF should be concise, self-explanatory, and user-friendly. The filling instructions (CRF Completion Guidelines) will be provided to study investigators for error-free data acquisition.

  • Data entry, if applicable

  • Medical coding using WHODrug & MedDRA dictionaries

  • Serious adverse event (SAE) reconciliation

  • Management and integration of local laboratory reference ranges with CRF data

  • Data validation, discrepancy management, data extraction, and database locking are assessed for quality at regular intervals during a trial.

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