Despite the opportunities offered by the digital revolution of recent decades, the organizational and management model of clinical trials has not changed significantly. The reason for this is because the industry is notoriously conservative, risk-averse, and highly organized in silos, which makes it slow to explore some of the latest technological advances in data analysis that can help conduct more efficient clinical trials.

The challenge of data complexity in clinical trials

Today we are faced with the expansion and convolution of studies, their globalization, stricter regulations, and the influx and management of vast amounts of data from multiple and non-communicating systems.

To manage this unprecedented amount of data generated in clinical research, it is necessary to use software and advanced analysis systems to visualize the data while the study is in progress, in order to create all the metrics required to manage the activities, data and documents, to highlight trends and any problem, to identify risks and to provide stakeholders with a comprehensive view of the performance of the trial and, in the case of multiple studies, the entire clinical portfolio.

Genius Wizards: the Exom Group solution

Exom Group has been the first full-service digital CRO in Europe, that in 2018, has started the Genius Wizards project, i.e. the use of Advanced Analytics (SAS Viya) in the management of all components of a clinical trial. Today, after almost 18 months of design, development, testing, and validation, Genius Wizards has become fully operational. Let us now explain how it works and how it impacts processes.

 

Enables more in-depth reviews of the clinical study

By integrating data from different sources and processing a complete and updated report for each type of parameter, Genius Wizards provides an immediate view of the quality and nature of data and documents of the clinical center, as well as of the performance of all staff involved, from ethical-administrative submissions, to the monitoring and management and analysis of data.  This approach certainly makes the work of the project team more efficient and effective, and at the same time, the study sponsor can observe and keep track of anomalous parameters detected during the execution of the study.

Increases data quality

In a typical study, it is more difficult to find inconsistencies between related variables using traditional data cleaning methods – which are manually intensive and prone to errors. Discrepancies that we do not notice or expect to create inherent quality or compliance problems. Genius Wizards, through a machine learning approach, analyzes data from different sources and formats in real-time, allowing data managers and study managers to avoid spending hours creating reports and identifying patterns and trends from hundreds of thousands of data points, identifying problems that go beyond typical data quality assessments. As a result, data cleaning and queries are also drastically transformed and automated.

Data Mining

Genius Wizards allows you to follow the progress of the main parameters of efficacy and safety, while the study is running,  and to effortlessly identify deviations from the average values in individual centers, to report any inconsistent data both in a single patient and between several patients, to identify differences in the reporting of adverse events, to note the protocol deviations and any potential misconduct.  All this information is also made available to the study promoter, thus ensuring maximum transparency and timeliness.

Data-driven and timely corrective actions

Genius Wizards offers interactive data exploration using images such as dispersion diagrams, waterfall graphs, bubble graphs, and time series, decision trees, linear and logistic regressions and much more. With these reports, data managers and study managers can improve their decision-making and orchestrate timely corrective and preventive measures.

Here are some examples of the several hundred reports that you can generate in Genius Wizards:

Conclusion

These real-time final balance and predictive analyses, obtained through the use of Advanced Analytics, generate the added value that the pharmaceutical industry seeks in CRO partners to make better strategic and operational decisions.

Thanks to Genius Wizards, Exom Group offers its clients a unique opportunity to maintain constant and continuous supervision of the study and to carry out a more in-depth review of the data relating to all clinical and organizational aspects of the study.

The achievement of this new and significant goal, confirms the mission of Exom Group to modernize the traditional and inefficient processes in clinical trials through the combination of high operational expertise with innovative technological solutions.

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