Situation

  • Client had recently completed the last patient visit of a randomized double blind placebo controlled phase 3 study
  • Earlier clinical studies were promising, but if consistent and positive, the study results would represent confirmation of safety and efficacy and complete the registration studies needed for regulatory approval

Challenge

  • To date, there were no manuscripts published on the clinical data from this drug candidate
  • The results of this large phase 3 trial were unknown but several key and urgent decisions hinged on being able to communicate the results in a clear, concise, and compelling manner
  • There were several key stakeholder audiences for the data including internal clinical and medical leadership, corporate leadership, board of directors, external KOLs, broader medical community, financial analysts, and public markets
  • The data would come back from biostatistics in raw, unformatted tables and listing without graphical representations, not in a database format for ease of use, and, with no coherent story for communication

The Xelay Approach

  • Xelay Acumen Data Analytics team prepared ahead of receipt of data to create and iterate on the slide formats with the client, QC process and automation of converting raw data into usable electronic formats, prioritized the order of analyses, and create mock presentations for each stakeholder audience
  • Strategic planning of data analytics allows for rapid generation of professional quality graphical representations and appropriate communications to various audiences which in turn enables informed strategic decision making
  • In 72 hours from receipt of raw non-electronic data, Xelay was able to produce 500+ clinical data slides for senior management review and subsequent presentation to board of directors and press release
  • In less than 10 additional days, a primary manuscript was submitted and accepted by one of the top 3 medical journals and a late-breaking abstract was submitted and accepted for an oral podium presentation at the premier medical conference for this therapeutic area