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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


  • 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 […]

  • The use of Veeva systems, a suite of clinical trial solutions, continues to grow. Veeva’s products offer robust functionality, a clean user interface, and excellent reporting capabilities, making their products an industry favorite for small and large life science companies. However, companies must be prepared for all the changes that come with implementing a new […]

  • The European (EU) Medical Device Regulation (MDR), adopted in 2017, was a sizeable update to medical device regulations. The EU MDR is a new set of regulations governing the production and distribution of medical devices in Europe, and more specifically, designed to modernize the EU regulatory system to better address the current needs of the […]