Collecting Clinical Data in a Post-COVID Environment

Prediction: In 10 years, clinical trials will be nearly paperless and clinical trial historians will note that the Coronavirus pandemic was the tipping point.

Every study has been affected. Sponsors are delaying or extending existing trials, postponing new trials. And they’re redesigning their clinical processes to work in an altered and uncertain situation.

Clinical operations will change in many ways. But some of the first — and easiest — are technology-related.

Direct Data Capture, Patient Safety, and Paperless Efficiency

Commonly known as DDC, direct data capture is the technological process by which site staff directly enter clinical data into a mobile application or EDC system. It’s a proven and readily available technology that reduces or eliminates monitor travel — thus, yielding safer studies.

Products such as Medrio DDC facilitate online or offline clinical data collection with all the benefits of EDC — smart forms, calculated values, notifications, and alerts. They eliminate the need for paper source and double data entry and produce higher quality data.

With real-time data synchronization, your source data is available for immediate remote monitoring. Both pharmaceutical companies and CROs can satisfy monitors’ queries and conduct source document verification without ever setting foot on site.

These are key benefits now. But they’re also great benefits well after we return to industry “normalcy.”

Ensuring Great Results with DDC Technology

Deploying studies using direct data capture can ensure that you get great results — even from your first trial leveraging the technology. That success is a function of your data management team.

Experienced data management teams can support the deployment of Medrio DDC (for example) for any size project, helping you:

  • Build your study database
  • Review and verify data
  • Format data for submission to regulatory authorities

Critically, expert data management teams will also help you identify data issues or functions that require special attention by augmenting your data collection processes with enhanced data visualization tools. Aggregating data from any source also streamlines your analysis with historical trends and real-time alerts.

Combined, DDC and data visualization take your efficiency, safety, and compliance to a new level.

Taking Advantage of the Silver Linings

It shouldn’t take a virus to make us look at process breakthroughs where we need them most. But COVID-19 is forcing us to think beyond our traditional processes. The key is not to adjust only for the here and now, but transform processes that provide advantages well into the future.

And Veranex (formerly Quartesian) is no stranger to the kind of data management that ensures speed, safety, and efficiency. Whatever your challenges, we can put you in a position to succeed today and tomorrow.

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