AG Mednet has released a Submission Quality & Compliance module that delivers quality assurance software to support organizations in the clinical trial ecosystem, including imaging core labs, clinical research organizations, imaging trial sponsors and principal investigators.
The Submission Quality & Compliance module comprises automated quality assurance software built to detect errors at the investigator site prior to data submission, the company said. On average, preventable mistakes can delay a clinical trial for up to seven weeks. These errors range from technical oversights such as inconsistent data entry and improper sequencing of medical image scans, to human error such as missing signatures or authorization and illegible handwriting.
Boston-based AG Mednet said its Submission Quality & Compliance module features include:
- Confirmation that parameters in a medical image set are compliant with predetermined protocol ranges at the exam, series and instance level;
- Identification and alerts for missing information and instances;
- Assurance that specified views (e.g., coronal, sagittal, axial) are present;
- Automatic series selection and upload so only the required data arrive at the trial repository;
- Verification that the required series were taken in the right sequence;
- Capability for trial coordinator to acknowledge discrepancies, thus opening and closing potential queries concurrently with data submission; and
- Customization options for reporting to senders, core labs and sponsors, including acknowledgements through electronic signatures.