Our dedicated research staff centrally manages SARC sponsored clinical trials in both pediatric and adult sarcomas, providing a wide range of services to support and encourage clinical and laboratory research.

Study Development

  • Coordination of protocol development
  • Budget development
  • Consent development/review
  • File the IND application with the FDA and annual IND reports
  • Provide operational input to the core study documents including the protocol, informed consent and eCRF, etc.
  • Executes contract with vendors
  • Enters the study into clinicaltrials.gov and updates the study as needed
  • Registers the study in pharma-specific report systems
  • Provides operational input into selection of external partners.
  • Prepares slides for the SIVs and conducts the SIVs with the PI

Study Operation

  • Establish trial master file for essential documents
  • Communicates the study status regularly and escalates unresolved issues
  • Provides updates on operational timelines
  • Ensures the maintenance, tracking and accuracy of operational data milestones
  • Reviews and manages variances between actual and forecast spending across the operational budget.
    Communicates variances and action plan for resolution.
  • Review, approval and sign-off of study related invoices
  • Primary contact for affiliates to maintain oversight of performance, issues and resolution.
  • Provides operational information and/or reviews safety information/reports
  • Responds to protocol questions from sites, IRBs, external vendors etc.
  • Primary day to day contact for operational related activities where appropriate.
  • Orders drug supply and makes sure sites have adequate drug at their sites
  • Submit protocol deviation/violations to the PI for review
  • Submit trial safety events to the PI for review
  • Prepare monthly agenda/minutes for the SARC Clinical Trials Review Call
  • Follow up with sites to ensure the data is entered timely

Study Close Out

  • Help prepare the manuscript and submit manuscript
  • Post any results to clinicaltrials.gov
  • Review the database and issue queries when necessary
  • Close out the sites
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