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Data Management

Amarex offers two data collection options: electronic data capture (EDC) for electronic data entry at sites or paper case report forms (CRFs) for paper data entry collected from sites and entered in-house. The computer system used for data collection, processing, transfer and storage is 21 CFR Part 11 compliant and has been validated by multiple FDA audits. Our 100% web-based system offers real-time data management capabilities to sites and sponsors.

To meet timelines, database setup and database lock are performed at industry-leading speed, and we provide tables and listings of accumulating data during the treatment phase of a clinical trial, allowing sponsors to conduct ongoing data reviews.

Our Integrated Safety Database (ISDb) takes multiple databases from multiple clinical trials, for a single product, and makes them uniform so that safety data from all the databases can be analyzed through a single database. The ISDb is a powerful tool to analyze the safety data of multiple studies, and to rapidly generate safety data for annual IND reports.

Data protection and integrity is maintained through:

  • An access-controlled data center
  • Regular data backups with off-site storage
  • Backup power
  • Disaster recovery procedures
  • 24/7 monitoring by IT staff

‚ÄčServices include:

  • Data management plan
    • Trial specific
    • Version controlled
    • Data processing
    • Nomenclature conventions
    • Medical term coding specifications
    • SAE and AE reconciliation procedures
    • Final and interim data lock procedures
    • Data entry instructions
  • Case report form design
  • Custom-designed databases for each clinical trial
  • Database customized programming (EDC or paper-CRF)
  • Data collection, data entry and validation
  • Analysis dataset creation and transfer
  • Multiple-study integrated safety database
  • eCRF design
  • Customized status reports and trackers
  • Data cleaning
  • ePRO
  • Amarex representative presenting CIOMS report - Pharmacovigilance Services | Amarex

    Pharmacovigilance

    Our highly experienced clinical safety professionals provide clinical and medical expertise to evaluate the safety and conduct of Phase I-IV clinical trials.
  • Diabetic Measuring Lancet Instruments on White Background - Biostatistics services | Amarex

    Biostatistics

    We identify the best method of analysis for each individual protocol, determining efficient and accurate pathways to product approval.

Contact Us

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