According to industry research, more than half of all image-related clinical trial query stoppages result from preventable human errors, causing an average delay of up to seven weeks.
AG Mednet recognizes that the current system is imperfect, and in response created its Submission Quality & Compliance module – a new layer of automated quality assurance – to reduce submission error rates and bring preventable delays to zero. This module is the first quality assurance software built specifically to detect errors at the investigator site prior to data submission in order to accelerate clinical-trial decision-making.
The Submission Quality & Compliance module delivers benefits and quality assurance to all organizations in the clinical-trial continuum in a way not possible until today.
Imaging-Trial Sponsors rely on extensive data points to make critical assessments about the viability of a therapy and clinical trial. If data points are missing, delayed, or inaccurate, decisions sit in limbo. The Submission Quality & Compliance module identifies more than half of all preventable errors that delay clinical trials and creates a system for careful, organized, and precise data capture.
Imaging Core Labs (ICLs) help pharmaceutical companies reach critical “go- or no-go” decisions faster. The Submission Quality & Compliance module immediately detects errors that result in queries, forcing acknowledgement of the query and allowing the ICL to expedite the transfer and analysis of critical data, assuring that submissions are correct and evaluable based on the clinical-trial protocol. This module provides customized reporting and on-site “take action” features that save time and money.
Clinical Research Organizations (CROs) manage, design, monitor and report on all aspects of clinical-research trials including patient enrollment and participation. The Submission Quality & Compliance module gives CROs a system to verify information, automatically update support systems including EDC (electronic data capture), and dramatically reduce the amount of queries returned for correction or re-scanning.
Principal Investigators (PIs) are leading researchers dedicated to improving drug therapies and patient outcomes. Preventable errors stall clinical trials and impact ongoing patient participation. The Submission Quality & Compliance module helps PIs manage compliance more easily and accurately than ever before possible, and significantly reduce the overhead required to manage queries long after data has been submitted.
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;
- Flexibility to send individual image series 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.