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Data Integrity & Compliance

How we help with Data Integrity & Compliance

Clinical development sponsors have incorporated more technology use over the years, resulting in sponsors investing in numerous clinical vendors and services as they move throughout their phases of development. The disparate systems often result in a complex data ecosystem, and the outsourcing often results in the generation and transfer of massive quantities of data. Many sponsors and vendors do not have clarity around data integrity requirements and regulations, putting their product development programs at risk. Halloran consultants are subject matter experts prepared to define data strategies and ensure data is inspection-ready.

Halloran Supports:

  • Electronic Master Files
  • Regulatory Information Management Systems
  • Clinical Trial Management Systems
  • Electronic Data Capture
  • Data Visualization
  • Electronic Patient-Reported Outcomes
  • Electronic Clinical Outcome Assessments
  • Electronic Quality Management Systems
  • Electronic Document Management Systems
  • Electronic Signatures


  • Biocom California’s first annual Converge Summit, recently held in South San Francisco, brought together life science leaders and executives to exchange ideas, foster collaboration, strengthen relationships, and spark innovation. When we think of innovation for this industry, the topic of Artificial Intelligence (AI) in clinical trials has steadily gained momentum, particularly around the opportunities and […]

  • A Trial Master File (TMF) is an ecosystem of documents used by monitors, auditors, assessors, and sponsors to demonstrate that a clinical trial has been conducted in compliance with Good Clinical Practice (GCP) and the approved protocol.  The TMF is an essential quality process, enabling documentation of all activity that has been performed during the […]

  • Halloran’s CORE East, a three-day intensive retreat for clinical operations executives and life science leaders, is the epicenter of a movement aiming to disrupt the traditional landscape of clinical research.   The best and brightest came together and sought to revolutionize the drug development process and its impact on healthcare. A few sessions emphasized embracing the […]