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Data Management

Data management for clinical trials is paramount to ensure subject data is accurate, complete, and reliable. Our data management team will design clinical and/or safety databases tailored to the needs of your program to empower you with the data outputs you need quickly and efficiently while ensuring data quality, integrity, and regulatory compliance.

Our customizable data services can include:

  • Database design, development, and maintenance

  • CRF design

  • Data processing

  • EDC system and end-user training

  • IVRS support

  • Data cleaning and query management

  • CRF and data query tracking

  • Medical coding using WHODrug & MedDRA dictionaries

  • SAE reconciliation

  • Preparation of Statistical Reports – Interim, Final and Clinical Study Reports

  • Generation of SAP

  • Coordinating and managing DMC/DSMB/ad-hoc outputs

  • Data visualization for SAB or Board Meetings

  • Database transfer

  • Database lock and archival

Contact us to learn how our data management team can empower your development program.

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