Features & Benefits | Example | ||
SYSTEM |
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Instant Data Sharing | Always connected (Cellular or WiFi) allows study team to review data as it is collected | |
10" Tablet | Size allows for easy incorporation of all detail normally captured on paper source document | ||
Multiple Language Support | Can support multiple languages, as needed, based on study requirements | ||
Flexible Interface | Interface allows user to jump between screens, as easy as flipping between pages of paper. For example, a user can jump between Vital Signs and ConMeds without losing data. | ||
Highly Customizible | Any study source document or CRF can be designed into the DCDC system. All systems are customized specifically to study requirements. | ||
Portability | May be used at remote centers, patient homes, study sites or doctor offices. | ||
IMPROVED DATA QUALITY |
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Accuracy | Checks data upon entry for format, range, type and allowable values | |
Completeness | Ensures data fields are complete/questions are answered | ||
Consistency | Data collection is consistent across all users and countries | ||
Quality Assurance | User has the ability to quality control data before it is submitted | ||
COST SAVINGS |
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Monitoring Costs Decrease | Eliminate Source Data Verification | |
No Data Entry from Paper | Eliminate Transcription Costs & Errors | ||
Significantly Reduce Queries | Lower Costs & Study Team time | ||
Labor Costs Reduced | No Printing, Proofing, Distribution, etc. | ||
IMPROVE COMPLIANCE |
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Real-Time Quality Checks | Each session is checked for completeness before session is complete. | |
Real-Time Compliance Monitoring | Each session can be reviewed by SC before being transmitted to EDC. | ||
Real-Time Communication | Instant communication between team-members due to access to current data at all times | ||
IMPROVE MEDICAL SAFETY |
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Medical Standards Enforced | Treatment can be stopped under certain conditions (e.g. wrong doctor order) to avoid potential safety events. | |
Alerts | Custom email or text messages alert staff immediately of safety events. | ||
Efficient Adverse Event Processing | AE processed and PI alerted for assessment | ||
Consistent Training | Customized training modules enforce system understanding, before being granted access. |
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.
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