investigator site wishes

"We want a solution that works in a busy clinic, one that helps us rather than hinders us!"

Investigator sites are the primary end user of an electronic Data Capture (eDC) system. Cmed recognized this early in the design of Timaeus. Forcing investigators to use a method of data capture that doesn't suit them is likely to prove counterproductive. Therefore, Cmed (funded by a large pharma company) conducted specialized market research surveys, Investigator focus groups, a large global workshop and follow-up workshops with investigators, with the objective of determining what these users really want and ensuring that they approve of Timaeus as it was being built.

Although some Investigators and study co-ordinators prefer electronic data capture and transmission to the paper CRF process, many study coordinators and Investigators, experienced in eDC use, grumble about systems being too slow to use, unsuitable for use in a busy clinic environment, impossible to use to capture data with a patient in front of them: over 50% 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 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, the following features have been incorporated into Timaeus:

• Fully portable appliance option with automatic wireless communications and built in fingerprint biometric for both system access and digital signature. Thus no password nightmare!
• Multiple Timaeus appliances wirelessly communicate with each other in the clinic
• No need for internet dial-up or fast internet connection. Will work via low bandwidth GSM and/or GPRS, wirelessly.
• Automatic self-hunting communications.
• Very fast to use. Able to enter data live in front of patient
• Complexity removed from eDC. Deliberately uncluttered, simple screens for easy use by end users without computer experience
• Direct data capture from medical devices
• For those who prefer web access, very fast, crisp screen changes even with powerful cross-visit validation checks firing through Timaeus's web-enabled user interface
• Central and local lab data loading and management, including remote loading. All lab data available to site through eDC
• 'Scroll back in time' audit trail to help the site understand what has been done. (Often more than one coordinator may work on a study/patient)
• CRF completion guidelines located close to fields for completion

Cmed and the pharmaceutical sponsor of this research concluded 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. In the 21st century, it was concluded, 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.