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Healing Hearts & The Power of Innovation

Sharon Rosenberg: Jun 6, 2017 5:43:18 PM

On this day in 1961, the American Heart Association announced a new test to detect heart defects in kids, using amplified sound to find heart murmurs & other abnormalities. 

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.

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.

Synchronizing Serious Adverse Events and Electronic Data Capture using E2B

Rich Davies: Oct 30, 2016 5:32:59 PM

Electronic data capture (EDC) has emerged as the predominant way to collect data during clinical trials.  At OmniComm Systems, we’ve seen the application of EDC across all therapeutic areas and phases of clinical trials. EDC has become the norm in terms of the way pharma companies operate and collect data from clinical sites.

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?

Feeding the masses – a single platform to serve up clinical data that satiates all appetites

Rich Davies: Apr 1, 2016 5:27:48 PM

Clinical data captured through electronic case report forms (eCRFs) has always required conversion and delivery to data consumers, such as biostatisticians, for subsequent downstream processing. The volume and variety of clinical data is ever increasing as are the stakeholders and systems that want to consume it.  It would be fabulous if our data consumers could all accept the data they need in the same format. Alas the real world dictates that many of these consumers have their own preferences for both content and structure. The once simple data exports of tables for biostatisticians have increased in complexity. Industry standards such as CDISC SDTM have added the need to transpose and manipulate clinical data in the process of data export, not just provide simple tables per unique eCRF in the trial. The ability to link with other complimentary technologies such as pharmacovigilance systems introduces additional file formats (ICH E2B R2 and R3). This requires yet another specialized export that maps data from the eCRF to a unique, complex data standard.  This necessitates an intelligent export to provide relevant clinical data at the time a specific adverse event (AE) occurs. Data Safety Monitoring Boards may require safety-specific cuts of data. Site personnel may want targeted consolidated views of data across eCRFs and patients such as AE summaries or key-endpoint variables for review. Central or on-site monitors may also need targeted, consolidated views of clinical data summarized across sites to review key risk indicators (KRIs) in a world of risk-based monitoring (RBM). It makes sense then that the eCRF system used as the source of so much clinical data is equipped with the capability to aggregate, manipulate, transpose, export, and visualize the data it collects in any of these scenarios or in anticipation of future scenarios that will no-doubt arise. To that end, OmniComm has consistently expanded its TrialMaster® EDC Custom Data Export Utility into what is today a more holistic and comprehensive data delivery solution that supports the granular control of data to diverse consumers. This novel utility removes the need for downstream data wrangling and conversion required by more generic data exports and places traceability for data exports within the EDC design environment. Users can now manage all their diverse data delivery needs from within a single solution that reduces complexity of their operations with associated cost savings.