DATA MANAGEMENT

INTEGRITY

Amarex  offers two data collection options: EDC (Electronic Data Capture) for electronic data entry at the clinical sites or paper CRF (Case Report Form) for paper data entry that is collected from the clinical sites and entered into a database by Amarex staff members. The computer system that is used for data collection, processing, transfer and storage is 21 CFR Part 11 compliant. Being 100% web-based, it offers real time data management capabilities to clinical sites and sponsors.

Data protection is maintained through various elements:

1) Access-Controlled Data Center

2) Regular Data Back-ups with Off-Site Storage

3) Back-up Power

4) Disaster Recovery Procedure

5) 24/7 Monitoring- IT Staff

Services include:

  • Data Management Plan

    • Trial Specific | Version Controlled | DM Process | Nomenclature Conventions | Medical Term Coding Specifications | SAE and AE Reconciliation Procedures | Final and Interim Data Lock Procedures | Data Entry Instructions

  • Case Report Form Design

  • Customized Designed Databases for each Clinical Trial

  • Database Customized Programming (EDC or Paper-CRF)

  • Data Collection, Data Entry and Validation

  • eCRF Design

  • Customized Status Reports / Trackers

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