Skip to main content

Click Here to Learn More About trial interactive’s mobile-first CTMS

US-Based Biotech with 300 Employees Selects TI eTMF

Running a Pivotal Phase III Study with 640 sites in 30 countries

CHALLENGES

  • Transitioning from a major CRO to 4 smaller CROs to manage the study moving forward
  • The new CROs needed to be onboarded and only given access to specific documents and parts of the TMF they were responsible for
  • Required coding and uploading of hundreds of documents and reconciliation of numerous essential documents
  • Needed increased TMF oversight and centralization

 

OUTCOME AND ROI

  • Trial Interactive TMF Expert Services scanned, coded, QCd, and merged all of the paper documents into the eTMF. All missing essential documents were recovered
  • Seamless onboarding of 4 CROs with controlled access to TMF
  • Trial Interactive increased document visibility, transparency, and control through KPIs and dashboards leading to a more organized TMF
  • Increased oversight and centralization lead to an improved standard for managing the TMF outside of the TI platform and in the future
  • The Biotech was able to continue the study, the drug has been approved and is currently on the market. They were also able to pass an EMA inspection months after the study was completed