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Company FAQs
What is assisTek’s experience with Phase I studies? What is the typical cost for Phase I, II or III studies?
assisTek has completed numerous Phase I studies ( i.e. studies with a large number of VAS scales and studies with a large number of patient questionnaires).
– Arrow The cost varies depending on the scope and complexity of the trial, but prices are very competitive with other vendors.
What is the support breakdown, at assisTek, when assigned a project?
Business Developer: Role is to work closely with the study team to define solution, and is an advocate for the sponsor. Routes concerns back to assisTek project team.
– Project Leader: Maintains strict timelines, ensures System Requirements documents are inclusive of all sponsor needs and protocol requirements.
– Software Development Team: Experienced and innovative software team with multi-discipline programming backgrounds creates system that is structured to meet and exceed the needs of the sponsor.
– Test Team: Responsible for rigorous testing of software and hardware under strenuous conditions to assure system reliability.
– Client Services Team: Responsible for creating training documents, training sites, and supporting sponsor after first patient.
– Project Leader: Maintains strict timelines, ensures System Requirements documents are inclusive of all sponsor needs and protocol requirements.
– Software Development Team: Experienced and innovative software team with multi-discipline programming backgrounds creates system that is structured to meet and exceed the needs of the sponsor.
– Test Team: Responsible for rigorous testing of software and hardware under strenuous conditions to assure system reliability.
– Client Services Team: Responsible for creating training documents, training sites, and supporting sponsor after first patient.
Does assisTek work with vendors outside the USA?
Yes, assisTek has conducted clinical trials in 40 countries, supporting 38 different languages in 35 therapeutic areas.
How long does it take assisTek to deliver a system for a trial?
It takes anywhere between 6-12 weeks, depending on customization and complexity of the study.
What is the largest trial assisTek has ever supported?
The largest study assisTek has ever supported reached to over 1,000 patients.
Are all of assisTek’s solutions CFR 21, Part 11 Compliant?
Yes.
Does the customer have to provide the Android tablets to be used in study?
No, assisTek provides a complete solution, including hardware.
Since assisTek’s solutions support many languages, does assisTek also provide translation services?
Typically sponsors will provide assisTek with translated questionnaires and source documents. However, if needed, assisTek works very closely with a partner that provides this service.
Does the customer have to pay for cellular data transmission for devices?
assisTek’s pricing includes telecommunication costs for each device. The rate is negotiated based on volume, and is significantly less expensive than if a sponsor or CRO tried to pay for cellular service directly.
What age groups have used your products?
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.
System FAQs
How robust is the eDiary design from a programming usage standpoint? (e.g. mid-study changes, inclusion of unscheduled visits, inclusion of alerts, etc.)
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.
– 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.
Are there ever problems with transmission?
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.
– 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.
How do you monitor entry compliance?
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 details
– 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 details
Can the system be qualified as a working database?
Yes, the system can be used as a working database, including audit trail & query management.
What actions are taken in the case of a device malfunction?
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.
– 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.
What happens if a patient loses their eDiary?
The patient would notify their site. assisTek would ship a replacement device within 24 hours!
How long does it take assisTek to deliver a system for a trial?
It takes anywhere between 6-12 weeks, depending on customization and complexity of the study.
What age groups have used your products?
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.
