Monitoring

Our monitoring services support your project from site selection to closeout, providing experienced monitors and quality results all the while.

All of our site monitors are highly qualified clinical research professionals and share experience in multiple therapeutic areas. Our monitors are:

  • Required to be Certified Clinical Research Associates (CCRA) with the Association of Clinical Research Professionals (ACRP).
  • Highly experienced, with an average of 10 years experience in a broad spectrum of medical specialties and therapeutic areas.
  • Highly educated, with more than 50% possessing advanced degrees and/or nursing backgrounds.
  • Regionally based throughout the US and Canada, reducing travel time and the expense of site visits.
  • Responsive, flexible, and skilled at adapting to a variety of SOP practices and corporate cultures.

We at DSP have a unique compensation structure for our monitors, and it’s part of the reason we champion a very low turnover rate amongst our monitors. This creates greater study continuity, monitor dependability, and fewer learning curves. Additionally, each monitor is assigned fewer studies, allowing them to be more involved in each study.

Our monitors use state-of-the-art communications and management tools to provide timely and responsive communications, real-time data and reporting, and centralized tracking and management of study data and milestones.

DSP Monitoring services include:

Study Startup

Pre-Study:

Our monitoring team ensures your project is equipped with the best sites to meet enrollment targets and study timelines:

  • Monitors are trained to carefully evaluate sites during pre-study evaluation visits and communicate recommendations regarding their participation in your trial.
  • Through a detailed site inspection and interview with site staff, our monitors identify sites that will enroll quickly and provide quality data.
  • Trip reports capture site visit activities, significant findings, and action plans, if needed.

Site Initiation:

Providing site staff with proper training is critical in conducting trials according to the protocol and ICH/GCP. Our experienced monitors conduct initiation visits to prepare sites with a solid foundation of knowledge for your specific study requirements:

  • Protocols are presented through PowerPoint.
  • Hands-on demonstrations of equipment and systems (EDC, IVRS, etc.) promote an effective learning experience.
  • Inventory of Investigational Product (IP) and storage assessment.
  • IP dispensing and dosing education.
  • Regulatory review is completed to ensure files are complete and sites are maintaining documents as appropriate.
  • Trip reports capture site visit activities, significant findings, and action plans, if needed.

Study Conduct

Throughout your study, our monitoring team builds collaborative relationships with site staff and the project team:

  • By maintaining frequent communication and routine visits, the monitors are able to support investigative sites to enroll the appropriate patient population and minimize protocol deviations.
  • Metrics are followed closely through the use of our CTMS and the study EDC to monitor enrollment, queries, and study data to proactively manage sites and the quality of their work.
  • Monitoring goals are established in advance of every site visit to ensure appropriate prioritization of visit activities.
  • Trip reports capture site visit activities, significant findings, and action plans, if needed.

Study Closeout

Our monitors work to leave sites in an “audit ready” status at all times. Closeout visits finalize these activities:

  • Our monitors ensure investigative sites are knowledgeable of their final responsibilities.
  • Time is spent to prepare sites for the possibilities of future audits.
  • All regulatory documents and applicable study logs are collected and compared to our Trial Master File to ensure completion of regulatory files, both on-site and at DSP.
  • Study source documents are confirmed as present and complete. Appropriate storage plans are identified.
  • Trip reports capture site visit activities and all open actions are followed through completion.

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