Clinical Monitoring and Site Management

Just-In-Time 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-driven 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.

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 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 that is collected on-time and on-budget.

Using TEMPO each CRA will manage site visit objectives including:

  • Ensure signed informed consent forms
  • Source Data Verification (SDV), based on the protocol SOP
  • Review all eCRFs and discuss trends with site staff
  • Evaluate eCRFs for serious adverse events
  • Perform drug accountability
  • Review investigator study files for completeness
  • Ensure protocol compliance
  • Encourage 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

Clinipace Worldwide employs top-notch clinical research associates (CRA) who are led by experienced clinical directors and project managers. All monitors:

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


Clinical Team Management

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