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Imaging Endpoints SMO provides:

  • Clinical Trial and study identification
  • Top Doctors in the Valley as Principle Investigators
  • Study start up essential documents
  • Contract and Budget preparation and execution
  • Site preparation for each clinical study
  • Centralized Management
  • Ongoing study management
  • Rapid study start up (budget and contract negotiation with Sponsors, IRB Submissions)
  • IRB submissions
  • Source documentation development
  • Protection of research subjects via adherence to GCP/ICH Guidelines (NIH/CITI GCP certification)
  • CRF and eCRF certified staff
  • Experience in Phase II, III and IV studies
  • Qualified, Trained, Certified, and Experienced clinical research professionals
  • Study recruitment
  • Prescreening through site EMR
  • Frequent on-site development training for investigators and staff to ensure sites are regulatory compliant and consistently meeting end study results
  • Onsite study staff
  • Scheduling subject’s study visits and Coordination of subject transportation to and from visits enduring retention until study completion
  • Ensure accuracy of data
  • Interaction with EC/CRO/Labs/Sponsor/PI
  • Blood draws, PK/PD experienced, and processing according to IATA requirements
  • IATA-certified
  • Study outcomes
  • 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
  • Protocol Development
  • SOP Development
  • Grant submissions
  • Study Close out
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