June 2020 Update from Global Data Management Experts, Navitas Data Sciences

What is on the minds of our clinical data experts?

  • The new DM Landscape
  • Quick Turnaround in Database Migrations
  • Smart Data Listings & EDC Capabilities

Breakthrough pharmaceutical compounds are meaningless without accurate, comprehensive clinical trial data. Without such data, pharmaceutical companies are unable to provide the safety and efficacy validations needed to bring therapeutics to market and to the patients who need them.

Unfortunately, in today’s fast-paced, high-pressured clinical development environment, a challenge exists with maintaining the cleanliness, completeness, and overall quality of clinical trial data. Clinical teams are spending valuable (and costly) time cleaning data rather than analyzing it. This time-wasted reconciliation of trial data issues is a major detriment and can result in anything from small snags to severe setbacks (that could potentially require a re-run of the trial). This challenge will only become more difficult to navigate as the volume and variety of EDC-driven data continues to increase.

Navitas Data Sciences’ answer to these challenges is to hire and retain the best Data Managers and Project Managers. We empower our Data Management Project Managers to ‘own’ their studies, and passionately conduct them from a Project Management standpoint. Our forward-thinking Senior Associates understand the ‘molecule to market’ process, can build protocols into live databases, and can swiftly migrate databases when necessary (on average a database migration can take anywhere from 15-35 days depending upon the complexity).

The Navitas Data Sciences suite currently contains Data Managers, SAS Programmers, EDC Programmers, and Biostatisticians who can be embedded in any size client account. Smart data listings and decreased manual review efforts allow us to improve efficiencies as data flow increases. Knowledgeable edit checks and well-programmed dynamics that enhance entry accuracy (at the site level), greatly accelerate the back-end analysis and review processes. These tools (especially when coupled with Spotfire or Tableau business intelligence), can be used to optimize comprehensive data collection, data analytics, and data visualization as we move forward.

To Navitas Data Sciences, the end-to-end Data Management project ownership, data governance, and meticulous understanding of the study (and clinical trial processes) are what our managers do to confidently drive trials forward successfully. Our Data Management Teams can chair Data Review and Working Group Meetings, create study matrices and dynamics, write complex edit checks/UATs, perform reviews during study conduct (ensuring data entry completeness/cleanliness), and meet database lock timelines consistently. We see the remedy for the aforementioned ‘future Data Management issues’ in the distinct and high-caliber people we hire and retain. Their expertise and foresight enable them to swiftly navigate the unexpected variables that routinely occur in the new landscape of where Artificial Intelligence and EDC Data Management systems come together to improve the efficiency of trials.