DATA SCIENCE & BIOMETRICS

 
A data-driven world requires a data-driven mentality for clinical trials. Data Science is not just data management, but an entirely new approach that transforms data from a necessary burden to a driver of clinical trial success.

Built on Data Standards; Built for Success

When we built the Biorasi data management platform process, we built it differently than other CROs. Instead of asking “how do we manage all of this data being generated by a trial?” we started with the question “How can we make trial data an integral part of guiding trial progress?” We believe that data science should not be a rote process, a commodity offering or an afterthought in trial design and management.

STANDARDIZED FROM THE START

Biorasi’s data team doesn’t wait until the end of the trial to standardize data. We put it into CDISC format from the start, making it instantly useable.

More Than data management

Biorasi’s data science team doesn’t just manage your data. We use advanced analysis to turn your data into a powerful asset for managing your program.

BIG data approach

Our data processes leverage a first-in-the-industry big data approach to gain actionable insights from your trial data in real time.

integration and transparency

Our TALOS platform integrates data from every one of your sources, including metadata, and gives you unparalleled transparency into your trial.

Transforming Trial Data Into A Powerful Asset

Our approach begins by building out a standard data structure before the trial even starts. Instead of waiting until the end of the study to standardize data for submission, we take advantage of – and build our workflow around – the CDISC SDTM and ADaM standards right from the very beginning. Not only does this approach save time in filing later, but it makes the data immediately useful across a range of functions. We are passionately committed to the CDISC standards, which are poised to become the global accepted standards for data in the same way that ICH-GCP standards govern the clinical realm. In this increasingly data-driven world, treating data as an asset rather than a liability and leveraging its power will put our Sponsors at an immediate advantage when compared to their competitors.

Our Data Science and Biometrics services include:

  • Database development, programming and validation
  • User administration, training and support
  • Data validation programming
  • CDISC standardization
  • Data review, query and reporting
  • Tables, figures and listings creation and validation
  • Interim and final biostatistical analysis
  • Adaptive study design
  • Data transfers and integrations

"One of the rarest events, where we had to communicate [to Biorasi] to stop the screening rather than boost it."

VP of Global Clinical Development, Top Specialty Pharma
 

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