What do we offer?
COMPUTER HARDWARE AND SOFTWARE SYSTEMS
  • The computer hardware we use is of the latest technology to optimize efficiency, allowing reduction in cycle times and
    achievement of rapid database locks.
  • Our data management software uses Sybase SQL Anywhere Database Engine as its database system.
  • Software in use include the statistical package SAS® (v9.2), WinNonlin Pro (v5.2) for PK parameter estimation, MedDRA
    (v12.0) for coding of drugs, conditions and adverse events and Clindex (v3.76) data management system.
  • Each computer is password protected. Policies require passwords to change every 3 months. Backups are made
    daily and taken offsite.

SOFTWARE VALIDATED AND 21 CFR PART 11 COMPLIANT
  • Clindex, the Data Management software we use meets the criteria established for validation of systems to ensure
    accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records.
  • The functionality of the application as it applies specifically to 21 CFR Part 11 is proven and can be provided.
    For each relevant paragraph of 21 CFR Part 11, a statement can be provided that explains how the product
    supports compliance.

STANDARD OPERATING PROCEDURES (SOPS)
  • Our SOPs are highly integrated into our Data Management system. Each employee is trained on relevant SOPs for his/her job description.
Phone : +27 (21) 949 6992
Fax : +27 (21) 949 6932
Email : haylenenell@ttctrials.co.za
cgfourie@telkomsa.net
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