TEK eCOA Features and Benefits

System

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

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

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

Real-Time Quality Checks

Each session is checked for completeness before session is complete.

Real-Time Compliance Monitorin

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

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.