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Imaging Endpoints SMO Provides:

  • Experience in Phase 0/I, II, III and IV studies
  • Leading, experienced and high-enrolling physicians as Principle Investigators
  • Onsite study staff; qualified, trained, certified, and experienced clinical research professionals with CRF and eCRF certified staff
  • Protocol Development, SOP Development, Grant submissions
  • Rapid study startup (budget and contract negotiation with Sponsors, IRB Submissions)
  • Source documentation development
  • Site preparation for each clinical study
  • Prescreening patients through site EMR
  • Study recruitment
  • Scheduling subject’s study visits and coordination of subject transportation to and from visits enduring retention until study completion
  • Protection of research subjects via adherence to GCP/ICH Guidelines (NIH/CITI GCP certification)
  • Centralized and ongoing study management
  • Blood draws, PK/PD experienced, and processing according to IATA requirements
  • Interaction with EC/CRO/Labs/Sponsor/PI
  • IATA-certified
  • Frequent on-site development training for investigators and staff to ensure sites are regulatory compliant and consistently meeting end study results
  • Diligent Investigator oversite of study conduct through daily communication of subject’s assessments, outcomes, and regulatory changes.
  • Physician hospital privileges in the event of an SAE
  • Quality assurance audits to ensure data is collected in the form of ALCOA
  • Study closeout
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