More than half of all image-related clinical trial query stoppages result from preventable human errors, according to industry research. In response, AG Mednet has launched its Submission Quality & Compliance module that delivers a new layer of automated quality assurance to reduce submission error rates and bring preventable delays to zero.
The Submission Quality & Compliance module is the first automated quality assurance software built specifically to detect errors at the investigator site prior to data submission in order to accelerate clinical trial decision-making. On average, preventable mistakes 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 simple human error such as missing signatures/authorization and illegible handwriting.
“AG Mednet allows for quality control starting at the time of image retrieval, rather than when the images arrive at the core labs. This enhanced model increases throughput speed and quality to a level not previously seen,” said Christian Teague, core lab administrator, 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. By lowering query rates and ensuring data integrity, AG Mednet is constantly adding value to our work on clinical trials.”
The Submission Quality & Compliance module, an extension of AG Mednet’s product suite, aims to increase the overall quality, accuracy and consistency of a submission while significantly decreasing clinical trial queries. Features include:
- 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;
- Assurance that specified views (e.g., coronal, sagittal, axial) are present
- Automatic series selection and upload so only the required data arrives at the trial repository
- Verification that the required series were taken in the right sequence
- Ability for trial coordinator to acknowledge discrepancies, thus opening and closing potential queries concurrently with data submission
- Customization options for reporting to senders, core labs and sponsors including acknowledgements through e-signatures
AG Mednet’s technology network supports all organizations in the clinical trial ecosystem: imaging core labs, CROs, imaging trial sponsors and principal investigators.