Visiting Trial Sites at the Right Time

We Will MONITOR IT.

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