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Pharmacovigilance and Electronic Data Capture: Interview with an Expert


Electronic Data Capture

New standards, such as the ICH E2B (R3), enable serious adverse event reports to be compiled and sent to pharmacovigilance groups in a standardized electronic format, which facilitates the process of sourcing serious adverse event data from sites.

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October 12, 2016 | by Sarah Hand, M.Sc.

While clinical trials are increasingly making use of electronic data capture systems to streamline the collection and analysis of study data, pharmacovigilance professionals have not universally adopted this method. New standards, such as the ICH E2B (R3), enable serious adverse event reports to be compiled and sent to pharmacovigilance groups in a standardized electronic format, which facilitates the process of sourcing serious adverse event data from sites.

To learn more about how electronic data capture can be used to automate transmission of E2B-formatted serious event reports to the appropriate pharmacovigilance team, I spoke with Rich Davies, Executive Director of Business Solutions, OmniComm Systems, Inc. Rich supports organizations as they adopt OmniComm solutions from a technical, functional and business process perspective.

For a more in-depth discussion of electronic data capture, serious adverse events, E2B and pharmacovigilance systems, register for OmniComm’s upcoming webinar.

What trends have you seen in recent years in terms of the adoption of electronic data capture (EDC) systems?

Electronic data capture has been the predominant way that data has been collected on clinical trials, and we've seen that across all therapeutic areas – or phases – of clinical trials. It's really become the norm in terms of the way pharma companies operate and collect data from the clinical sites that they're working with.

Are there still some organizations that are continuing to use more conventional methods of serious adverse event data transfer? If so, why do you think this might be?

When you look at the collection of specific pieces of data like serious adverse events, then there has been a latency in terms of trying to drive the collection of that data through electronic systems. The main reason behind that is because of the rigor that needs to be applied to that data in terms of making sure it's in the right format for subsequent use. So by that, I mean that the way in which data is collected on an electronic data capture trial doesn't necessarily facilitate the subsequent reporting of serious adverse events. It requires some degree of manual intervention and oversight because technology hasn't been properly supporting that process. It has left customers operating as they always have done, with the processes that they always have used for collecting that data on paper.

Does electronic data capture help organizations better manage pharmacovigilance requirements?

Electronic data capture alone doesn't help organizations manage requirements; it takes an electronic data capture solution that provides the pharmacovigilance users the appropriate interface to manage that safety data, and prepare it for its downstream use to properly facilitate an electronic process for reporting serious adverse event information.

What challenges does the ICH E2B (R3) guideline present to organizations?

The need to get data in a specific format like E2B (R3) means that there are technical challenges in terms of having that data converted into that standard from whatever standard it’s collected in the first place. But it's not just the technical conversion of the data from one format to the other, it's the content of that conversion as well. Just being able to get your data into E2B (R3) format won't solve the problem. You need to be able to control exactly what data is converted and how it gets converted into that format to truly mean that you can go on to use E2B (R3) format for consuming serious adverse event information.

Can you highlight some of the key differences between the E2B (R3) format and the former E2B (R2)?

Both of them are in XML format, but the E2B (R3) format goes on to include more information than was previously collected in the E2B (R2) format. It also has more structure and information embedded within it, so E2B (R2) is a much simpler representation of the data compared to E2B (R3). E2B (R3) utilizes HL7 (Health Level Seven) for its structure and that makes it readable by many more systems than just pharmacovigilance databases, so E2B (R3) is even more useful and consumable than its predecessor.

What can our audience expect to learn from your upcoming webinar?

They will learn that it is possible to facilitate a truly electronic reporting process for serious adverse events collected at sites, through to consuming that information within their own pharmacovigilance systems, and then subsequently onward reporting of that information to the regulator.

To gain further insight from Rich Davies, register for OmniComm’s upcoming webinar.

Are you implementing an electronic data capture system in your organization? Share your thoughts in the comments section below.

Keywords: Pharmacovigilance, Electronic Data Capture, Serious Adverse Events



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