Sadly, most clinical trial data is manually typed into the EDC system from other source records. This delays the entry and analysis of the data – sometimes by weeks – and leads to a significant extra expense in performing Source Data Verification during monitoring visits. The obvious solution is to capture the data automatically from electronic sources, but a variety of technical and regulatory challenges have made the adoption of eSource a slow and uneven process.
OmniComm has wide expertise and sophisticated product capabilities to accelerate the adoption of eSource:
In TrialOne:
Direct device interfaces for barcode scanners, digital scales, ECG machines and vital signs machines
Audit trail for direct data capture that includes timestamp, device name and serial number
Handshaking with Laboratory Information Management Systems via HL7 messages
Configurable file imports from delimited ASCII, XML or HL7 source files
Label printing for users, patients, instruments, freezers, sample tubes and urine containers
Support for attached files on any event
Online real-time review, approval and eSignature of eSource records
Submission-compliant PDF study archive as a “certified copy” of the eSource records
In TrialMaster:
File import from delimited ASCII, XML or ODM source files
Data feeds from external systems via API calls using the CDISC ODM model
Support for attached files on any form
Configurable links to cloud-based imaging systems
Built-in capabilities to support online clinical adjudication
eSource information in the audit trail – original timestamp, device name and serial number
Submission-compliant PDF trial archive as a “certified copy” of the eSource records
A number of successful EHR integrations
Don’t be scared of eSource. You’ll be in good hands with OmniComm.
