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The Data Arch

Dennis Constantinou: Nov 20, 2016 9:01:38 PM

When strategizing a clinical trial, data might seem like that annoying mountain of numbers that you are forced to analyze, but it is a living and breathing part of the project – maybe the most important part. Data tells a story and if you listen, it guides the trial and keeps it moving forward.

Data is an arching stream that runs through the center of any project to carry the natural elements that give it life. It might seem easier to push it aside through the various stages of the trial, but the sheer bulk of it suggests taming it is the wiser choice, but how? Consider ways creating a system to maintain and organize the data arch improves a clinical trial.

Risk-Based Monitoring EDC System Enablement

Dennis Constantinou: Nov 13, 2016 9:37:52 PM

Clinical trials are not nice neat compartmentalized studies that occur in one lab. They tend to be massive projects that cover as many as 500 different sites – that means 500 locations producing data for collation and analysis. Instead of looking for a needle in a haystack, monitors have to tear apart 500 different haystacks looking for the one errant needle.

Historically, monitors went from site to site to investigate potential problems and make sure everything was running as planned. Electronic data capture and risk-based monitoring have changed the way monitors function to improve processing, reduce backlogs and enhance clinical studies.

Tomorrow's EDC: More Than Clinical Trial Data

Dennis Constantinou: Nov 6, 2016 7:33:47 PM

Historically, ancient civilizations relied only on observation to confirm the effectiveness or the toxicity of a drug, but early in the 20th-century therapeutic reformers looked for a better and less dangerous approach. Today, at the heart of every medical advance is a clinical trial backed by supporting data provided via electronic data capture (EDC).

Pharmaceutical companies use trial data to prove drug efficacy and safety to governing agencies like the Food and Drug Administration. Investigators scrutinize both pre-clinical and clinical analysis to determine the pros and cons of an emerging medication before approving it for public use.

While the importance of trial data for pharmaceutical development should never be overlooked, electronic data capture has a bigger role in the medical industry. Consider some other ways OmniComm Systems strives to broaden EDC solutions and better serve the medical community.