[Source]
Compliance module brings quality control directly to the site to ensure zero-delay data integrity
Boston, MA – May 14, 2012 – More than half of all image-related clinical trial query stoppages result from preventable human errors, according to industry research. In response, AG Mednet announces 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. AG Mednet’s technology network supports all organizations in the clinical trial ecosystem: imaging core labs, clinical research organizations, imaging trial sponsors and principal investigators.
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,” says 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.”
Specific AG Mednet Submission Quality & Compliance module 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 electronic signatures.
“The multitude of moving parts in a clinical trial make it highly susceptible to needless errors, both technical and human, which create costly inefficiencies in the system, slow the decision-making process, and can have a significant negative impact on the trial,” says Abraham Gutman, president and CEO of AG Mednet. “The Submission Quality & Compliance module is an important extension of our product suite that will dramatically increase the overall quality, accuracy and consistency of a submission while significantly decreasing clinical trial queries.”
For more information about how the new AG Mednet module delivers benefits and quality assurance to imaging trial sponsors, imaging core labs, clinical research organizations and principal investigators in a way not possible until today, please visit www.agmednet.com/zerodelay.
About AG Mednet
AG Mednet automates, expedites and improves outcomes in clinical trials by ensuring quality and compliance within critical medical imaging processes. Founded in 2005, AG Mednet is the leading quality compliance partner for image data submission and collection for pharmaceutical, biotechnology and medical device companies, imaging core labs and clinical research organizations managing clinical trials globally. More than 14,000 registered users across thousands of investigator sites in 60 countries use AG Mednet to participate in projects sponsored by each of the world’s top 20 pharmaceutical, biotech and medical device companies.
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