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Data Management & Review2018-02-07T17:10:47+00:00

Clinical data management plays a key role in the set-up and conduct of a clinical trial. We provide tailored, efficient data management for clinical trials to capture your data to support insightful and effective data analysis ensuring you meet key milestones.

Our data management services are in line with industry standards and are CFR compliant. We collaborate closely with you to design study specific case report forms for the collection of data as well as creating and testing study databases ready for data entry, performing data validation and query resolution, ensuring quality control and transferring data. We also have the expertise to clean, transform and integrate external data sources.

Our services include:

  • Project Timeline/Budget Management

  • CRF Design

  • Data Entry

  • Database Design and Build

  • Data Check Design and Build (Paper and EDC)

  • Database/Data Check User Acceptance Testing

  • EDC Training Data Query Management

  • CDISC Standards Implementation (SDTM and ADaM)

  • AE/SAE Reconciliation

  • Local, Central, and Corelab Data Handling/Management/Reconciliation

  • Medical Coding (MedDRA)

  • Data Management Documentation (Data Management Plan, Data Transfer Agreements, etc.)

  • Investigator Meeting Presentation/Support

  • Data Management Metrics/Reporting

  • Quality Management – With experience in GCP and ISO standards

Other Services

Innovative analytics solutions that derive better information from your life sciences, pharma & healthcare data.

Data
Clinical Study Protocol Development
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Team
Statistical Analysis Planning & Execution
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Training
Hot House Simulation
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Want to find out more? Get in touch