Development History

Timaeus is an intelligent data acquisition and management system, which uses the latest technology. It was designed as a 21st century solution to take eDC and data management technologies to a new level.

“The history of technology has shown you can only modify and improve a technology so much. If you really want to leap forward, you need to start again and invent a new technology”

Timaeus was designed without legacy AFTER the dot-com era. In other words, Cmed had no legacy investment in any Clinical Data Management System (CDMS), e-diary or similar system to protect. Nor did we jump on the web bandwagon of the dot-com era and rush to develop a system using tools and architecture better suited for online shopping. We believe that there’s no point in having sophisticated, powerful technology if it is unreliable, unable to scale without ‘super server’ power, or is too slow or too complex for inexperienced clinical site end users.

Instead, we spent 18 months carefully thinking and planning through requirements, and building and evaluating prototypes. This was done with the help of experienced management from large pharmaceutical companies – with a thorough practical understanding of clinical research, global clinical data management and the demands on investigator sites – allied to cutting-edge software engineers originating from Oxford University, England.

Investigator sites are the primary end-users of an electronic Data Capture (eDC) system. Cmed recognised this early in the technology’s design. Forcing investigators to use a method of data capture that doesn’t suit them is likely to prove counterproductive. Therefore, we conducted specialised market research surveys, investigator focus groups, a large global workshop and follow-up workshops with investigators (funded by a large pharma company). The objective was to determine what these users really wanted and ensure that they would approve of Timaeus as it was being built.

This shows in every aspect of Timaeus. The result is a carefully designed and engineered system that from top to bottom is “fit for purpose”. Although many investigators and study co-ordinators prefer eDC and transmission to the paper CRF process, many users – experienced in eDC use – complain about systems being too slow to use, unsuitable for use in a busy clinic environment and impossible to use to capture data with a patient in front of them. In fact, the majority of site users still thought it was a data entry burden forced on to them that causes much additional work. Others, particularly the investigators, complained of the hassle and problems in having suitable dial-up and fast internet connections installed, or enabling the hospital LAN to access eDC web sites. The need for portability, not only within a clinic but also between separate hospital buildings, was repeatedly cited – as was the need to collect data by eDC at patients’ homes, for some primary care studies in children or the elderly.

The ‘constantly changing password’ nightmare was a shared horror story, as was “and then we’re told off and cited by auditors for writing them down”. Some study coordinators even admitted to maintaining a password notebook.

As a result of these and other findings, many groundbreaking features have been incorporated into Timaeus. Find out more about Timaeus’ features.

The conclusion was that eDC alone, especially a web-only tool, was not enough. What was needed was an iDAM system that could seamlessly handle multiple data capture media from paper CRFs, through to a sophisticated appliance eDC, a fast web UI and even patient e-diaries. It was concluded that in the 21st century portability and use of wireless technology was now an essential requirement.

It was absolutely clear that one approach would not fit all, and that what was needed was a radically new type of system. A “fit for purpose” data acquisition and management system, like no other.