Q1. How robust is the eDiary design from a programming usage stand point? (e.g. mid-study changes, inclusion of unscheduled visits, inclusion of alerts, etc.)
A1. assisTek solutions are designed with these scenarios in mind. For Example:
Inclusion of unscheduled visits: There would be a button option to include unscheduled visits, and would include pertinent questions/forms.
Inclusion of Alerts: Our systems always have logic/rules to trigger alarms and alerts.
Mid-Study Changes: Mid-study changes are implemented by uploading software remotely to the device. These changes would be incorporated without sending the device back to assisTek.Back to Top
Q2. Are there ever problems with transmission?
A2. Transmission issues are rare, occurring less than 0.05%
Our software has the capabilities to auto-resend data until data transmission is successful.
In the rare instance the device fails or data is corrupted during transmission, the patient data is all backed up on the device SD Card.
For all devices that are transmitting data over a cellular 3G/4G network, Wi-Fi may always be used as a back-up.Back to Top
Q3. How do you monitor entry compliance?
A3. There are several ways assisTek monitors and encourages compliance.
Logic built into the software to ensure the user completes entries properly.
Alarms to remind the patient to complete daily entries.
Text message alerts to patient’s mobile phone, and/or to the study team.
Web reports with compliance detailsBack to Top
Q4. Can the system be qualified as a working database?
A4. Yes, the system can be used as a working database, including audit trail & query management.Back to Top
Q5. What actions are taken in the case of a device malfunction?
A5. Due to the in-device SD Card, all patient data can be recovered if the device is not working.
A new device will be shipped in 24 hours
Optionally, the patient can collect data on paper until a new device arrives.
assisTek will ensure the data recorded on paper is compliant once entered into the system.Back to Top
Q6. What happens if a patient loses their eDiary?
A6. The patient would notify their site. assisTek would ship a replacement device within 24 hours!Back to Top
Q7. How long does it take assisTek to deliver a system for a trial?
A7. It takes anywhere between 6-12 weeks, depending on customization and complexity of the study.Back to Top
Q8. What age groups have used your products?
A8. All - every age group ranging from young kids battling Cystic Fibrosis to elderly adults recording Angina episodes. System features are always customized based on patient population.
According to the FDA guidance on source data in electronic form, eSource will help to eliminate unnecessary duplication of data, reduce the opportunity for transcription errors, promote the real-time entry of electronic source data during subject visits, ensure the accuracy and completeness of data, and more.
|assisTek's TotalSource solutions capture these improvements to source data, and are customized to each individual protocol.||More Information|
assisTek successfully fuses new developments in mobile technology with creative software solutions to revolutionize the collection of data from patients and clinicians in clinical trials. We have proudly been helping clinical trial teams achieve success for over 18 years, in 40 countries with 46 languages. Our expertise can support studies in any phase.More Information