What is eSource:

assisTek’s TotalSource solutions are designed to create electronic source data at the point of origin, at any phase of a clinical trial. Source data has historically been collected on paper, and transcribed into an electronic database. eSource solutions allow the end user to create source records electronically without all the flaws and burdens of paper source data.

eSource documents and data may be generated in a number of places, under different circumstances. For example, a patient may be using an eDiary at home to collect event-based data that is related to a study medication. In other cases, a study coordinator may be using a Direct Clinical Data Capture system to collect critical clinician data during a site visit. In both instances, the data collected is pivotal to study results, and is collected electronically, in a manner that improves data quality, and reduces queries.

FDA Guidance on eSource:
According to the FDA, in the guidance titled “Electronic Source Documentation in Clinical Investigations”, source data in electronic form 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

The FDA guidance can be found here:
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM239052.pdf

assisTek is confident its system meets the FDA guidance and suggestions on eSource, and will have a positive impact on study logistics, results, and cost.

TotalSource Users and Modules:
assisTek’s TotalSource Clinical Trial system fuses multiple data-collection modules based on study protocol and requirements. All TotalSource solutions eliminate the need for paper source documents, because they are true eSource solutions. TotalSource is comprised of three types of modules that capture critical clinical trial data: Direct Clinical Data Capture, Patient eDiary and Electronic Outcomes. All modules are offered on 7” or 10” Android Tablets.

These tablets are lightweight, portable, and utilize 3G/4G cellular communication to sync study data instantly.

assisTek’s unique approach has created a system that allows multiple users (patients, coordinators, nurses, physicians, and monitors) to record, review, and follow-up on pertinent data at any time, from multiple points of contact.

Entire Study Team working from the same data

How do the modules work together in one study?
Any assisTek TotalSource module, including the Patient eDiary, Direct Clinical Data Capture, and Electronic Outcomes modules can serve as hybrid solutions; where two or more modules are used in a study, to collect eSource data that satisfies multiple endpoints, and requirements.

 Example 1 - A study may include the following requirements:

• Patient Reported Outcomes collected at monthly site visits
• Collect daily pain levels, concomitant medications, and undesirable events from patients in diary.

assisTek’s TotalSource system can handle both of these study requirements under one umbrella, as described below:

Example 2 - A study may include the following requirements:

• Collection of Vital Signs, Adverse Events, and Concomitant Medications during monthly site visits.
• Collection of Investigational Product dosing at patient’s home during self-administration
• Investigator review of AE’s within 24 hours

assisTek’s TotalSource system can handle these study requirements under one umbrella, as described below:

assisTek Portal for Reports and Training
The assisTek Portal allows study team members to manage the study efficiently with access to patient data immediately on the internet. assisTek’s TotalSource solutions communicate directly with the assisTek database using 3G/4G cellular communications, for the most up-to-date patient information at all times.

The assisTek Portal is the online hub for study management and user training.  Depending on the data collected during a study, reports are made available that may include:

• Screening Report
• Patient Compliance Report
• Site Visit Summary Report (i.e. Patient & Clinician Reported Outcomes, Clinical Data, etc)
• Event-based Reports (i.e. Adverse Events, Diary Events, etc)
• Device Management Report
• Training Report
• Customized Report (i.e. dosing escalation, study-coordinator follow-up, etc)

All users are adequately trained online, with videos and quizzes, based on their role in the study. For example, Study Coordinators would receive different training than a Principal Investigator.