Greater Visibility in Clinical Data Review


In the era of big data, it’s a dominant theme – the need to break down silos and better integrate and present data so more time is spent analyzing it and less time preparing it for analysis. Why should it be any different in clinical development?

With more than 208,000 trials going on worldwide, and each one involving broader and more diverse data sets and formats, organizations from big Pharma to virtual Biotechs to CROs are looking for tools that empower optimal analytics-driven decision-making.

Clinical development has evolved beyond the analysis of traditional data obtained from randomized clinical trials alone to determine the safety and efficacy of drugs. Today, translational and health outcomes data are being integrated with traditional clinical measures, making the analysis of this broader data set much more challenging, but also much more insightful.

Visual Analytics

Getting to those insights quickly is essential in an industry driven by time-, safety- and cost pressures. Medical monitors, safety review teams, biostatisticians, data managers, pharmacologists and others need tools that let them quickly analyze the breadth of available data. They need a complete picture of what’s occurring in clinical development – as its happening.

Optimally, data should be available for analysis as soon as it’s collected – from first patient in. Waiting weeks or months until data is collected, scrubbed, cleaned, and locked down is no longer an option.

An analytics platform that leverages data visualization can speed the clinical data review process by empowering clinical development teams to more easily see trends, outliers, and patterns buried in a sea of clinical data. This ability to quickly visualize and analyze data lets team members optimize the trial process and gain the insights to reduce risk, manage resources and investments for greatest patient benefit, and, ultimately, move drugs and devices faster to market.

What are some of the things people can easily identify or evaluate with a visual analytics platform?

     • Unknown relationships in data

     • Early safety signal detection

     • Data quality issues

     • Protocol violations and dropouts

At its heart, effective clinical trial management means finding – as early as possible – the things that are going wrong, or have the potential to go wrong. To plumb the depths of clinical development data, spending less time preparing it and more time acting on insights from it, requires the right visual analytics platform.

Clinical Data Source Integration

Whether virtual Biotechs or big Pharma, users need real-time access to aggregated data from multiple sources. There are a wide variety of clinical data sources: SAS®, Medidata Rave®, Oracle Inform®, and Oracle LSH®, are just a few. Connecting to these without scripting or IT involvement is key to accelerating data analyses. People who need the information no longer have to wait for customized reports enabled by IT or biostatisticians. Nontechnical people on the clinical development team must be able to easily leverage the solution too.

With a direct connector to SAS or Medidata Rave, for example, users can quickly gather information from source systems and, using intuitive visualizations that dig into the clinical data, spot outliers, patterns, and trends.

Perkin Elmer’s Clinical Data Review solution, which is powered by TIBCO Spotfire®, gives clinicians the visual analytics power needed to speed medical review, assess data quality, and identify causalities & relationships in the data. The insights gained can result in fundamental process improvements and cost savings:

     • Save days per week, per trial in medical review

     • Reduce database lockdown prep time

     • Quickly establish a safety profile of the data

     • Better understand key attributes from data exploration

     • Take questions to their next logical step

     • Visualize data in seconds, vs. waiting days for static reports

Cempra Pharmaceuticals called it “a best-in-class approach to analyzing our clinical trial data” while IDC Health called TIBCO Spotfire “the de facto end-user interface of choice for the strategic assessment of clinical data.”

Are you making the most of your clinical data review? Gaining insights at the earliest possible moment? Investing in the right visual analytics platform can make all the difference in the rapid, robust review of your clinical data.

For specifics on timely safety surveillance and optimizing data flow with our Clinical Data Review solution, check out our webinars.