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Sourcing Inquiry Logo Amarex

Amarex

Regions
North America
Countries
United States
Size
n.e.
Specialty
Human Medicines, Biopharmaceuticals
Service category
Clinical development and testing, clinical CRO
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Key services

Services

Regulatory

  • Regulatory strategy creation for clinical product development
  • FDA meetings and presentations
  • U.S. Agent to FDA for non-USA companies – Annual IND Reports, Drug Master File updates, etc.
  • FDA submissions – INDNDABLAANDA, 510K, IDEPMA
  • Clinical site, manufacturer site and laboratory audits – GCPGMPGLP
  • Chemistry & Manufacturing Controls (CMC) consultation for FDA compliance

Clinical Trial Conduct

  • Trial planning and project management
  • Protocol development
  • Investigator identification and recruitment
  • Global sites database
  • Site qualifications
  • Investigator meetings
  • IRB assistance
  • Third party vendor management
  • Clinical monitoring
  • Site initiation
  • Interim monitoring
  • Site training
  • Site closeouts
  • Site regulatory document control
  • Trial Master File maintenance
  • Safety monitoring
  • SAE database
  • Physician ‘hot line’
  • SAE narratives, Medwatch & CIOMS reports
  • FDA & sites notifications of SAEs
  • Annual safety reporting

Biometrics

  • ICH E9 compliance
  • CRF design (EDC or paper)
  • Database design and creation
  • Data entry and cleaning
  • Statistical Analysis Plan
  • Analysis tables, listings, and graphs
  • Online data review
  • Interim Analyses
  • Integrated Summaries of Efficacy or Safety
  • Exploratory and meta analyses
  • Multi-study data integration
  • Data Safety Management Board

Medical Writing

  • ICH-compliant Clinical Study Reports
  • Statistical Analysis Reports
  • Investigator Brochures
  • Protocols
  • GLP/GCP Audit Reports
  • Summaries, Manuscripts and Abstracts
  • Scientific papers
  • White papers

Approvals, Certificates, Authorisations

  • GCP
  • GMP
  • GLP
  • FDA

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