Visiting Trial Sites at the Right Time


Improved technology adoption and clinical operations processes are making it possible to redefine the role of clinical monitoring. At Clinipace, we have adopted a transparent methodology that differentiates the way we interact with our trial sites. Paired with our Clarity Stack technology tailored to each trial, providing real-time study stats, collaboratively we are able to develop a strategy focused on the activities you need to conduct a successful trial safely.

Our CRAs manage site visit objectives, including:

  • Obtaining signed informed consent forms
  • Sourcing data verification (SDV), based on the protocol SOP
  • Reviewing all eCRFs and discussing trends with site staff
  • Evaluating eCRFs for serious adverse events
  • Performing investigational product accountability
  • Reviewing investigator study files for completeness
  • Reviewing protocol compliance
  • Encouraging and supporting sites

Involved from study start through site closure, clinical directors and project managers provide oversight by:

  • Collaboratively working with sponsors and communicating every aspect of our monitoring activity throughout the engagement
  • Keeping projects on time or ahead of schedule
  • Mentoring CRAs and monitoring quality
  • Managing the clinical aspects of the study to collect clean and quality data
  • Managing all site-related activities, visit schedules and report preparation
  • Proactively identifying and resolving study-related issues