Phase II-IV and medical device studies

AmeRuss provides the following Clinical Operations Services for:

  • Feasibility Assessments
  • Pre study documentation collection, review, and translation
  • Regulatory submissions and approvals
  • Study sites selection, qualification, and recruitment including clinical research agreements
  • Conduction of investigator’s meetings and site personnel training
  • Pre Study Assessment Visits, Interim Monitoring Visits, and Study Termination Visits
  • Importation and handling of study products and clinical study supply as outlined for Phase I and Bioequivalence studies.
  • Central / Local Lab Management
  • Shipment of blood and biological samples including preparation of required documentation and customs clearance
  • Investigator and institutional grants administration
  • AE/SAE management and safety reporting