Q1. What is assisTek’s experience with Phase I studies? What is the typical cost for Phase I, II or III studies?
A1. 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).
The cost varies depending on the scope and complexity of the trial, but prices are very competitive with other vendors.Back to Top
Q2. What is the support breakdown, at assisTek, when assigned a project?
A2. 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.Back to Top
Q3. Does assisTek work with vendors outside the USA?
A3. Yes, assisTek has conducted clinical trials in 40 countries, supporting 38 different languages in 35 therapeutic areas.Back to Top
Q4. How long does it take assisTek to deliver a system for a trial?
A4. It takes anywhere between 6-12 weeks, depending on customization and complexity of the study.Back to Top
Q5. What is the largest trial assisTek has ever supported?
A5. The largest study assisTek has ever supported reached to over 1,000 patients.Back to Top
Q6. Are all of assisTek’s solutions CFR 21, Part 11 Compliant?
A6. Yes.Back to Top
Q7. Does the customer have to provide the Android tablets to be used in study?
A7. No, assisTek provides a complete solution, including hardware.Back to Top
Q8. Since assisTek’s solutions support many languages, does assisTek also provide translation services?
A8. 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.Back to Top
Q9. Does the customer have to pay for cellular data transmission for devices?
A9. 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.Back to Top
Q10. What age groups have used your products?
A10. 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