Without accurate, reliable data a successful clinical trial is next to impossible.

Amarex data systems produce accurate, reliable and secure data. Established computer security procedures, including nightly system back-ups and restricted network access, assure the safety of all Amarex data systems.

The expertise of our seasoned clinical data managers is an integral part of the clinical development process. The clinical monitoring team’s involvement spans from the CRF design to data lock and study closeout. The parallel
processing and preparatory procedures allow databases to be locked SOONER through continuous data cleaning and validation and rapid identification and resolution of data queries. Our data management system is robust, reliable, flexible, and easily customized to meet our clients’ specific needs.

The database system is a validated, proprietary VB based system that allows us to double-data enter, third party verify and validate data quickly. All CRF are processed through our Document Filing System and stored in a fireproof, restricted access facility.

Data Management Plan Flow Chart

Flexibility, Documentation, Accuracy, and Security are the four main characteristics of our data management system. The flexibility of the system allows us to integrate all inherited data from past trials. Thorough documentation via a protocol-specific data management plan, allows the sponsor to re-visit how data was managed several years later without losing any information. Accuracy is the result of a process-dependent rather than person-dependent system. System security allows for robust, reliable and reproduceable databases and resolution of data queries.

Amarex Data Management Services:

• Case Report Form Design
• CRF Tracking
• Data Management Plans
• Database Design
• Double Data Entry
• Automated Edit Checks
• Database Integration
• Data Coding and Cleaning
• Data Listings and Transfer
• Automated Data Queries

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