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Optum

Description: 

Optum™ Life Sciences helps pharmaceutical, biotechnology and medical device companies successfully address product development and commercialization challenges by delivering a full range of integrated solutions — in the areas of strategic insight, value assessment, evidence development, alignment to commercial needs, and launch support — that include:

Strategic Regulatory Services

  • Global Marketing authorizations (NDA, NDS, MAA)
  • Clinical trial authorizations (IND, CTA)
  • QA Services and GMP auditing
  • eCTD Services and Regulatory Publishing
  • On-demand Consulting
  • Medical Device and Quality Systems Support

Real World Data and Analytics

  • Integrated Clinical and Claims Data Licenses
  • NorthstarTM and ClinformaticsTM
  • Market analytics
  • Pharma informatics

Product Value Strategy Consulting

  • Evidence mapping
  • Pricing and reimbursement
  • Scenario planning

Health Economics and Outcomes Research

  • Market access research
  • Economic analysis (burden of illness, cost effectiveness, cost utility)
  • Decision analytic modeling
  • Comparative effectiveness research

Late Phase Research

  • Post-authorization safety studies
  • Registries — disease, product and safety
  • Prospective observational studies
  • Retrospective chart review studies
  • Pragmatic studies
  • Interventional Phase IV trials

Epidemiology and Pharmacovigilance

  • Risk management programs (REMS/RMP)
  • Pharmacoepidemiology Consulting
  • Signal detection
  • Pharmacovigilance Services with ARISgTM database
  • Qualified Person for Pharmacovigilance (QPPV) Services
  • Training

Patient Insights

  • Patient Reported Outcomes (SF-36 Health Surveys)
  • Medication Adherence Programs
  • Technology Solutions

Services: 

Chemistry/Manufacturing/Controls, Drug Master File Dossiers, Electronic Submissions Preparation, GMP Compliance, Health Economics, Medical Devices/Combination Products, Pharmacoeconomic/Pharmacoepidemiology Studies, Pharmacovigilance, Regulatory Affairs/Regulatory Strategy, Regulatory Document Preparation

Contact Information: 

Optum
13625 Technology Drive
Eden Prairie, MN, 55344, USA
Phone : 9056905773
Fax : 9056891465
Internet : www.optum.com/life-sciences-solutions
Email : darrell.ethell@optum.com
Contact Person : Darrell Ethell