Originally Published February 18, 2019
by John R. Fischer , Staff Reporter
Datatrak International launched the first electronic data capture (EDC) system this week for unifying medical image capture, display storage, and adjudication for clinical trials.
The solution will operate through the software-as-a-service provider’s Enterprise Cloud platform, and streamline FDA April 2018 guidance with remote image capture, analysis and annotation for compiling image and analysis data into clinical trial electronic case report forms (eCRFs) with role-based access to the patient, site, study and clinical program files.
“Our industry has struggled to deliver a technology capable of combining remote image capture and endpoint adjudication within a centralized EDC system using one source code and database. This has been an ongoing industry goal for years,” Scott DeMell, vice president of sales and marketing for Datatrak, told HCB News. “Datatrak has had the capability to do this for years and has done so already with ECG data but it has taken some time for the Life Science Industry to catch up. Today, DICOM data has become a growing source of study endpoints, and companies are now looking for a technology solution that can streamline the process.”
The move is considered by the company to be the next step for warehousing and managing CTMS, EDC, ePRO, eCOA and eConsent clinical data within its Enterprise Cloud, with the release of the system expected to reduce the cost and time lags of partial image adjudication due to standalone adjudicator system integration.
It also will eliminate trial-by-trial web services and API programming “connectors” that require redundant database exports and revalidation, actions that increase the potential risk for external exposure of patient efficacy and data security.
In addition, its combination of eCRFs and adjudication workflows enhances 21 CFR Part 11 compliance, a section of Title 21 of the Code of Federal Regulations which oversees FDA standards on electronic records and electronic signatures, and demands compliance from any clinical trial that makes use of an electronic case report format.
“The benefits of CFR 21 compliance can now be advanced with the unification of adjudication workflows and eCRFs which can trigger all conceivable quality checks upon image capture and/or adverse events. These intelligent workflows can be configured to meet all adjudication charter specifications necessary for resolving assessment discrepancies between blinded independent reviewers Clinical Endpoint Committees (CEC) oversight,” said DeMell. “Our products are all compliant, and include important functions covered in the regulation, such as secure, time-stamped audit trails that identify the time and date of user entries, previous and current values, and the reason for change for all modifications to the system.”