• 2390 Faraday Ave, Carlsbad, CA 92008 USA
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Clinical Operations

Clinical Site Monitoring

RPM provides extensive clinical site monitoring and management services from qualification and initiation to site closeout. Our CRAs (Clinical Research Associates) are proficient, knowledgeable and skilled professionals with comprehensive clinical research experience and are well versed in communicating within the study team members and multiple sites. Our CRAs perform all the monitoring activities in accordance with ICH GCP guidelines, SOP, Study Protocol and applicable regulatory requirements. RPM develops Sponsor agreed monitoring plan for each trial project.

Our Clinical Site Monitoring services include:

  • Clinical site identification
  • Site Qualification and Initiation visit
  • Subject Recruitment and Retention Support
  • Regulatory Document Preparation and Collection
  • Development of Study Specific Procedures, Manuals and Tools
  • Contract and Budget Negotiation
  • Investigator Meeting, Planning and Presentation
  • Clinical Site Personnel Training
  • IP (Investigational Product) Accountability review
  • Investigator Site Files review
  • Regular newsletters to sites
  • Letters to Investigator after each site visit
  • Monitoring Visit Reports to Sponsor
  • Routine monitoring visits with SDV (source data verification)
  • Monitored and collected CRF documents tracking
  • Query resolution and management support
  • Trial Master File (TMF) creation and maintenance 
  • Safety reporting (SAEs & AEs)
  • Pharmacy & Laboratory monitoring/reconciliation
  • Final Monitoring Visit Reports
  • Ongoing Site Monitoring and Management
  • Remote Monitoring
  • Site Recruitment and Enrollment Activity Monitoring
  • Protocol Deviations/Violations Tracking
  • Interim Site Monitoring visit
  • Site Close Out/Termination visit
  • Discussion on Site Responsibilities and Requirements

Site selection

A rigorous site selection is one of the main components of successful clinical trial conduct. RPM works closely with our clients to understand their preference for selection of sites. RPM evaluates clinical site past and present experience and performance track record prior to making proposals to our clients.

Our site selection services include:

  • Investigator Site Identification and Recruitment
  • Site infrastructure
  • Feasibility Assessments
  • Investigator's qualification, experience, prior ICH-GCP trainings and interest
  • Site staff with satisfactory qualification, experience and ICH-GCP trained
  • Past experience in similar clinical trials
  • Identify Geography of Patient Populations
  • Back-Up Site Selection
  • Maintenance of RPM’s Investigator Site Database
  • Trial essential facilities such as pharmacies and laboratories
  • Trial particular equipment e.g. imaging and measuring
  • Further sponsor requirements
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