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:
The FDA guidance can be found here:
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:
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?
Example 1 - A study may include the following requirements:
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:
assisTek’s TotalSource system can handle these study requirements under one umbrella, as described below:
assisTek Portal for Reports and Training
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:
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.
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