AG Mednet Helps Sponsors Comply with New FDA Guidance for Clinical Trials

Improved quality-control measures in clinical trials are gaining traction. AG Mednet driven by its mission of quality at the source for image-intensive trials helps sponsors and core labs comply with the FDA’s newly stated guidance. The FDA has issued “Guidance for Industry: Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring” for sponsors running clinical trials. According to this guidance “FDA encourages sponsors to develop monitoring plans that manage important risks to human subjects and data quality and address the challenges of oversight in part by taking advantage of the innovations in modern clinical trials.”

The guidance details how “a risk-based approach to monitoring does not suggest any less vigilance in oversight of clinical investigations. Rather it focuses sponsor oversight activities on preventing or mitigating important and likely risks to data quality and to processes critical to human subject protection and trial integrity.”

According to industry research more than half of all image-related clinical trial query stoppages result from preventable human errors causing an average delay up to seven weeks and pharmaceutical sponsors millions of dollars.

Introduced in 2012 AG Mednet’s Submission Quality & Compliance technology is the industry’s first automated quality control platform to detect errors in clinical trial data submissions at the source before they leave the investigator site and cause delays. With Submission Quality & Compliance software sponsors and laboratories can automate a significant portion of quality control tasks reducing time and cost in clinical trials.

“The FDA’s updated guidance encourages greater use of centralized monitoring methods” said Abraham Gutman president and CEO of AG Mednet. “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. By complying with this FDA guidance sponsors will realize improved quality control and more accurate outcomes.”

AG Mednet currently works with dozens of life sciences companies including the top 20 pharmaceutical biotech and medical device companies in the world. For more information about AG Mednet’s commitment to improving clinical trial quality please visit

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 17000 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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