Transformation: Technology

As discussed above, many organizations are choosing to build specialized, data-focused outsourcing partnerships to handle their data management, biostatistics, and statistical programming work, rather than choosing a ‘full-service approach’. Alongside harnessing these specialized partnerships to drive biometrics transformation, organizations can also build efficiencies by leveraging the technology stack and technology knowledge of outsourced partners.

In the light of the industry drivers discussed, organizations face an increasingly urgent need for a data ecosystem that ensures data quality and enables insights throughout the trial lifecycle. Leveraging a data management and analytics platform that centralizes trial data from all sources –such as the elluminate Clinical Data Cloudis an approach that addresses these challenges. With a platform approach, data silos are eliminated, manual work is reduced, and costly downstream errors are avoided. The benefits are multi-fold, including more efficient data-driven decision making, increased productivity, and accelerated cycle timelines.

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Combining biometrics services with technology can streamline both technology adoption and biometrics delivery, saving time and effort for the internal team and maximizing the return on investment. One example of successfully combining biometrics services with technology is illustrated illustrated by a recent client story which highlights how combining biometrics services and elluminate resulted in an ingenious solution for a top 20 pharmaceutical client, allowing them to effectively handle eSource workflows within a Phase 1 trial, and support fast-turnaround data review for dose escalation.

For organizations that do not yet have a statistical computing environment, managing statistical analyses is all too often a manual, disjointed process. With the increasing amount of clinical data available, more sophisticated methods, and an emergence of data science techniques, a high-performance computing environment is necessary to produce accurate and consistent results while maintaining traceability. Modern SCEs are an integral cornerstone of a forward-looking biometrics strategy within a digital age, increasing development efficiency and streamlining program execution.

For statistics and programming services providers, technology that eases ongoing statistical review rather than traditional milestone-based review processes enables greater proactivity and accelerates speed of analysis. Tools that enable standardization and automation are also key when it comes to submission-related activities such as ISS/ISE (Integrated Summary of Safety and Integrated Summary of Effectiveness) and DSURs (Development Safety Update Reports).

Working with a service provider who has adopted the same technologies offers several advantages in terms of streamlined processes, reduced errors and inconsistencies, and improved communication and collaboration. By working together with a common technology stack, the provider and sponsor can work together more seamlessly, with common tools and workflows aligned against common objectives. The results of these synergies include improved efficiency, reduced costs, and improved quality and reliability of clinical trial data. Similarly, leveraging biometrics providers’ technology infrastructure frees up the sponsor organization to focus on their core competencies and priorities.