Risk Based Monitoring

Improved technology adoption and clinical operations processes are now making it possible to redefine the role of clinical monitoring (within the context of trial operations), while at the same time decreasing costs and increasing clinical trial oversight. At Clinipace Worldwide, we’ve adopted a methodology called Just-in-Time Monitoring that is dramatically changing the way we interact with our trial sites.

We no longer over monitor poorly enrolling sites, how about you? With Just-in-Time Monitoring our activities are much more fluid and based on actual site enrollment, not some static plan that says we must visit every 6 weeks.

Monitoring As You Like It

Our technology-amplified Clinical Monitoring Services (CMS) are tailored to each client, based on the study protocol and client objectives. These solutions are available in whatever configuration meets your needs, and our TEMPO™ software platform provides peace of mind with always on, real-time study status.

With TEMPO™, implementing and monitoring clinical trials and registries has never been more efficient and effective. TEMPO™’s online protocol and SOP training model enables our monitors to be up-and-running quickly. Whether guided by our SOPs or yours (sponsor), the efficient and expert use of TEMPO™ not only saves money, but ensures study conduct occurs according to protocol while following GCP guidelines.

“Ultimately, data-driven solutions result in enhanced outcomes for the research sponsors and better relationships with the sites. And, providing cleaner data on time and under budget makes CROs more successful.”
– Carla Radke, Senior Director, Clinical Monitoring, Clinipace Worldwide

Monitoring Deployment

Our practice leader will work with you to define the right monitoring solution. Typically this will include a TEMPO™ configuration, site visits, a source data verification plan, site-focused telephone-based support, management reporting and oversight. At all times our clinical research associates (CRAs) are focused on keeping sites motivated and on track. Tailored to each customer and protocol, our site monitoring workbench (task list) ensures quality data is collected on-time and on-budget.

Using TEMPO™, each CRA will manage site visit objectives, including:

  • Ensuring signed informed consent forms
  • Sourcing Data Verification (SDV), based on the protocol SOP
  • Reviewing all eCRFs and discuss trends with site staff
  • Evaluating eCRFs for serious adverse events
  • Performing drug accountability
  • Reviewing investigator study files for completeness
  • Ensuring protocol compliance
  • Encouraging and support sites

CRAs make final visits to sites to close out studies once all CRFs have been completed, reviewed, and locked; and all queries have been resolved.

Monitors

We employ top-notch CRAs who are led by experienced clinical directors and project managers. All monitors:

  • Must demonstrate site monitoring and TEMPO™ CRA proficiency
  • Participate in ongoing training
  • Many have professional CRA certifications

Our CRAs are Site Managers

Unlike other CROs, we enable our CRAs (”monitors”) to serve as site managers. This ensures strong monitor-site relationships and expedites replies to monitoring requests. Trial teams can easily escalate findings of inadequately monitored tasks, ensuring that the entire monitoring team is on the same page to apply solutions and increase data quality. Client communication is also improved as the project management team can relay information to the client and allow for “real time” assessment and decision making to address the findings in a number of ways (i.e., client Good Clinical Practice (GCP) audits, client-PI interaction, etc.) and improve overall data quality.

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 ensuring quality monitoring
  • Managing the clinical aspects of the study to ensure the collection of clean and quality data
  • Manage all site-related activities, visit schedules, and report preparation
  • Proactively identifying and resolving study-related issues

CRAs strive to maintain good working relationships with the staff and investigators at the trial sites. Using remote monitoring to detect small issues before they become big problems means the CRA can be less punitive and more collaborative. Rather than visiting only every couple months, or issuing queries and directives, a CRA can use remote data analysis findings as a basis to share feedback more informally. Frequent communication builds trust, fosters partnership and strengthens the relationship with the site. CRAs can work collaboratively with site personnel to proactively seek solutions rather than dictating what must be done.