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Timaeus use in mid-to-late phase studies

"Does the eDC Emperor wear no clothes?" (EDC and Beyond, IIR, 2006)

Most large Phase II and Phase III studies are conducted at Investigator sites in multiple countries, often with a near-global geographic spread. In order to efficiently manage the increasingly diverse nature of clinics and studies conducted today, it is clear that any electronic Data Capture (eDC) and/or Clinical Data Management System (CDMS) must be practical, flexible, robust and able to cope with many different situations.

This should be the obvious minimum standard from which to compare systems. However, too often this is not the case, and failings can prove costly when discovered.

The reality:

  • Certain studies are currently better suited to paper CRFs than eDC and vice versa
  • Some studies can be done more cost effectively using paper CRFs than eDC, and vice versa
  • Internet connectivity is never 100% guaranteed anywhere
  • Internet connectivity is not available in many parts of the world where there are actual or prospective Investigator sites
  • Broadband (fast internet) is not always available around the world
  • Wireless GSM/GPRS (low bandwidth), used in mobile / cell phones is now more widely available than telephone landlines in many countries
  • Multi-second eCRF screen refresh rates are not acceptable and frustrate busy study coordinators. Speed is important!
  • A large proportion of sites still need to have sponsor-provided hardware when asked to use web-based eDC systems
  • Hospital/clinic computers do go wrong, sometimes at critical times in a study
  • The sponsor is often powerless to help when the site's own computer has a problem.
  • Many sites still prefer to use paper CRFs: some sites (e.g. US-based trial specialist sites) are set up for and prefer web-based eDC while others want hardware and portability, orientated to clinic workflow
  • Some sites charge more for using eDC rather than paper

      • ... Clearly the list could go on and on. Perhaps the important conclusion is not to be fooled like the Emperor of the fairytale!

      The solution? There is no perfect solution, but the best solution is one that is the most flexible and best addresses the practical realities.

      Timaeus:

      • Seamlessly manages paper CRFs, web-based eDC and appliance eDC within a single system, and within a single study
      • Can use the internet, or wireless, or low bandwidth GSM/GPRS (can any other system in the world do this?), or 3G, or wired LAN or Wifi.
      • Is fast and easy to use in any data capture medium
      • Is algorithmically scaleable. Fast and powerful in the largest studies
      • Supports Data Safety Monitoring Boards and similar — e.g. proven ability to handle a mega trial database on a single, portable, disconnected laptop
      • Portability makes it possible to conduct paper-based DM at sites — e.g. an important but problem site

      In summary, there is no more complete, flexible or powerful system than Timaeus. It has now made every other system obsolete. It is a real world, practical, scaleable, "fit for purpose" system.