support of e-source

"Where is the sense in asking Investigators to first capture data on paper, and then type it into an electronic data capture system?"

Today, true electronic data capture in clinical trials barely exists. It is a myth. Why? Because current eDC systems, particularly those that are web-based, are ill suited to meet this objective. Instead today's eDC systems are in reality eDT systems, i.e. electronic data Transfer systems. The goals of improved data quality (rather than just reducing the number of nuisance queries) and real time access to data are not being achieved.

E-source is the term often used to mean the capture of data in a clinical trial directly into an electronic data capture system (eDC), rather than on paper or into the clinic's electronic medical records system. This can be done by entering data directly into the eDC system (indirect e-source), or better still by transfering data directly from medical devices that measure ECG, vital signs, spirometry, digital X-rays etc or from medical records systems (direct e-source).

In order for an eDC system to support indirect e-source it must be easy and very rapid to use in front of a patient, and nearly always portable. For direct e-source, it must be able to support wireless or direct data capture from medical devices.

Cmed believe that e-source is the desired future, and furthermore that technology now permits its practical application today. The only unrealistic aspect of e-source is the import of significant amounts of data directly from medical records systems. Simply, there are too many disparate systems in existence even within a single country, let alone across the world. These systems often fail to comply with the regulations pertaining to the capture and management of clinical trial data — meaning it could be decades before this type of e-source will take on significant levels globally.

Meanwhile, there is much to be gained in speed, quality, efficiency and cost savings via indirect e-source, and direct e-source from medical devices. Timaeus was engineered to support both types of e-source and is uniquely capable in this regard.

Cmed recognises the importance of ensuring that sites retain their "source data" and that safeguards are in place. These valid regulatory requirements are not insurmountable, especially with the right technology.

Below are some of the features/benefits of Timaeus in supporting e-source:

• Very fast to enter data — split-second screen refresh rates
• The most powerful validation checks that fire in real time, giving sites important feedback early on
• Full portability and multiple wireless modalities to ensure it will work in a busy clinic
• Automatic, robust communication between Timaeus stations and remote servers
• Direct data capture from medical devices. (Devices already integrated include ECG, Holter monitors, vital signs and spirometers)
• Timaeus can not only pull data from medical devices but in many cases take over remote operation of the device
• Local printing for site study records
• Fast data exports in CSV, PDF and XML
• Easy, 'go back in time' audit trail showing the full history of how each piece of data was generated, queried, amended etc. (No separate or convoluted audit trail views)
• Ability for patient biometric fingerprint recognition and validation opening many possibilities.