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Dennis Constantinou

Recent Posts

What Factors Delay Research Studies? Site Survey Delivers Answers

Dennis Constantinou: Jan 18, 2017 8:00:00 AM

Under a crush of data and protocols, very few trials are completed on schedule. In fact, only 6% of clinical trials are completed on time, with the overwhelming majority (72%) running over schedule by at least a month, according to the Center for Information & Study on Clinical Research Participation. Trial designs, increased patient enrollment and extended treatment periods also contribute to time delays, according to researchers in the life sciences industry.

Researchers Face Greater Challenges, Independent Study Says

Dennis Constantinou: Jan 4, 2017 8:00:00 AM

Site researchers report dramatic spikes in the number of procedures and the complexity of tasks related to clinical protocols over the last 10 years, according to an independent study.  Why? Clinical protocols that guide the research team’s activities have increased in complexity, generating more data than ever before.

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.

Database Lock - Not Lockdown

Dennis Constantinou: Oct 23, 2016 6:45:00 PM

The database lock is frustrating for sponsors and CROs because it often leads to costly delays. The lock should not mean lockdown, though. The data produced via a clinical trial belongs to the study sponsor and team, so why the delays?

How Important is eCRF Standardization?

Dennis Constantinou: Oct 16, 2016 6:10:11 PM

The electronic case report form (eCRF) is a tool to gather all the data from different electronic and paper based systems. It is important because it makes it possible to assemble and organize diverse data in a manner that fulfills the study protocol and allows the data to be reviewed and analyzed. Data from clinical studies must be integrated for FDA submission and it is beneficial if the data is collected in a standardized format from the start. Standard forms mean simplified electronic data capture (EDC) system training for in-house and site staff. They also streamline the flow of data from collection through submission, whether a single or multi-site study. Data exchange between partners and providers is facilitated, and reviewers can then work with the data with less preparation time.

Training Your In-House and Site Teams

Dennis Constantinou: Sep 14, 2016 4:03:06 PM

Proper training is the key to any successful project. Clinical study team training could mean the difference between a smooth and efficient process, and errors that cost time and money. Training provides guidance and education that will instill end user confidence and maximize operational efficiency.