New software from imaging-data specialist AG Mednet promises to cut submission errors in clinical trials involving medical imaging and to “bring preventable delays to zero”.
The US-based company says its Submission Quality & Compliance module is the first automated quality-assurance software built specifically to detect errors at the investigator site prior to data submission.
Industry research indicates that more than half of all query stoppages in image-related clinical trials are the result of preventable human errors, AG Mednet notes.
An average these mistakes, which range from technical oversights such as inconsistent data entry and improper sequencing of medical-image scans to simple human errors such as missing signatures/authorisation and illegible handwriting, will delay a trial for up to seven weeks, it adds.
At image retrieval
With AG Mednet’s software, quality control starts at the time of image retrieval, rather than when images arrive at core laboratories, the company emphasises.
“This enhanced model increases throughput speed and quality to a level not previously seen,” commented Christian Teague, core lab administrator at RadCore Labs.
“At the same time, the company’s network delivers extremely fast transit, which allows us to achieve a greater than 75% query reduction rate so sponsors receive information faster to expedite decisions.”
Among the features of the Submission Quality & Compliance module are:
• Confirmation that all 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.
• Automatic series selection and upload, so that only the required data arrive at the trial repository.