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Rich Davies

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Safety Data Reporting and Electronic Data Capture Solutions

Rich Davies: Feb 7, 2017 8:00:00 AM

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. However, it’s still reasonably normal to see serious adverse event (SAE) data be initially reported from sites on paper.

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.

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.

The Secret Behind Fast and Simple Data Review

Rich Davies: Mar 18, 2016 9:00:00 AM

The diverse stakeholders participating in an EDC clinical trial present equally diverse requirements for data access and visualization. At one end of the scale we have site users that are interested in quick access to specific data points, presented and summarized in a consumable format. At the other end of the scale we have data managers and perhaps medical reviewers who need a more explorative way of accessing clinical data. This means there’s no ‘one size fits all’ mechanism of surfacing and visualizing data to end users. The use of ad-hoc reporting or patient profiling tools has long catered to the data manager and medical review communities’ with interfaces that target the skill sets of those users and provide custom reporting or explorative data access as required. Site users have had less luck unless the sponsor has indulged their data access needs by building out specific reports in any ad-hoc reporting environment. Without this the investigators have been left to review the data of interest by walking through the patient eCRFs reviewing the data in exactly the format it was entered. It’s no surprise that this isn’t the most efficient way to deliver data of interest. It’s also not typical to grant site access to ad-hoc reporting environments where successfully self-serving data through custom reports requires a level of technical expertise combined with an understanding of the way the data is being captured and structured. Hence there’s a clear need for a fast and simple data review interface for site users, although the applicability can be across all stakeholders. To that end, OmniComm Systems developed Dynamic Report Data Grids, part of the TrialMaster EDC suite, that allows for the fast and simple creation of aggregated data views that can include any relevant data from within the clinical trial. When an investigator or other user is working within the interface, they can call up a Dynamic Report Data Grid at any point, executing at the patient, site or trial level as their privileges allow. The Data Grid provides additional sorting and filtering capabilities if required. With this capability an investigator can call up a serious adverse events summary, review patient self-assessments or key endpoint variables as required and they have fast, targeted data access at their fingertips. The use cases are boundless, so there’s no reason why monitors, data managers, medical reviewers and other stakeholders can’t add Dynamic Report Data Grids to their toolkit of data access options too!