Timaeus in mid-to-late Phase Studies

Most large Phase II and Phase III studies are conducted at investigator sites in multiple countries, often with a near-global geographic spread. Increasingly, many pharmaceutical companies are seeking clinical trial patients from the ‘emerging’ countries/markets.

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.

The reality:

• 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 universally available
• Wireless GSM/GPRS (low bandwidth), used in mobile / cell phones, is now more widely available than telephone landlines or internet access
• 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 and 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 CRFs than paper CRFs

There is no perfect solution, but the best solution is one that is the most flexible and best addresses the practical realities of each site, each trial, each situation.

Timaeus:

• Seamlessly manages paper CRFs, web-based eDC and appliance eDC within a single system, and within a single study
• Can use the internet, wireless, 3G, wired LAN, Wifi, or low bandwidth GSM/GPRS (can any other system in the world do this?)
• Is fast and easy to use in any data capture medium – algorithmically scalable
• Supports Data Safety Monitoring Boards and similar – e.g. proven ability to handle a mega trial database on a single, portable, disconnected laptop. It’s fast and powerful in the largest studies
• 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, scalable, “fit for purpose” system.