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FAQ

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Q1. What is assisTek’s experience with Phase I studies? What is the typical cost for Phase I, II or III studies?

Q2. What is the support breakdown, at assisTek, when assigned a project?

Q3. Does assisTek work with vendors outside the USA?

Q4. How long does it take assisTek to deliver a system for a trial?

Q5. What is the largest trial assisTek has ever supported?

Q6. Are all of assisTek’s solutions CFR 21, Part 11 Compliant?

Q7. Does the customer have to provide the Android tablets to be used in study?

Q8. Since assisTek’s solutions support many languages, does assisTek also provide translation services?

Q9. Does the customer have to pay for cellular data transmission for devices?

Q10. What age groups have used your products?

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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).

  Arrow    The cost varies depending on the scope and complexity of the trial, but prices are very competitive with other vendors.

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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.

  Arrow    Project Leader: Maintains strict timelines, ensures System Requirements documents are inclusive of all sponsor needs and protocol requirements.

  Arrow    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.

  Arrow    Test Team: Responsible for rigorous testing of software and hardware under strenuous conditions to assure system reliability.

  Arrow    Client Services Team: Responsible for creating training documents, training sites, and supporting sponsor after first patient.

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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.

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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.

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Q5. What is the largest trial assisTek has ever supported?

A5. The largest study assisTek has ever supported reached to over 1,000 patients.

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Q6. Are all of assisTek’s solutions CFR 21, Part 11 Compliant?

A6. Yes.

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Q7. Does the customer have to provide the Android tablets to be used in study?

A7. No, assisTek provides a complete solution, including hardware.

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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.

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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.

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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.

Improve Critical Study Objectives

  • Patient Compliance
  • Patient Engagement
  • Safety Management
  • Data Management

Learn more about improving key aspects of your study. More Information

eSource In Clinical Trials | Support FDA Guidance

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

Company Overview

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.

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