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RTI-HS HomeOur Services › Regulatory and Health Outcomes Strategy

Regulatory and Health Outcomes Strategy

Our Regulatory and Health Outcomes Strategy (RHOS) group provides health outcomes services to help bio-pharmaceutical and medical device companies communicate the value of their products. We use our broad therapeutic experience and expertise within all phases of clinical, regulatory, and post-approval development to help you maximize the value of your products in the marketplace.

When you partner with RTI-HS, you gain access to our experts in health outcomes strategy and research, medical writing, product label claim strategy, health economics, and patient reported outcomes. We provide deliverables tailored to meet the requirements of your internal or external stakeholders. Using our broad and industry-focused experience we provide comprehensive market access strategies and implement plans to communicate product value to your stakeholders.

Incorporate Outcomes Research Into Regulatory and Promotional Strategy
We perform assessments on products early in development and provide appropriate outcomes research (OR) plans to ensure the product will have the best potential of placement on payer formularies at launch. This includes competitive reviews of study endpoints and value message positioning. The OR plans provide a roadmap to help clinical and marketing teams maximize product value.

We also specialize in clinical trial design, developing appropriate study endpoints for drug labeling or product value messages for physicians, patients, and payers.

Develop and Communicate Evidence-Based Value Messages
We help our clients develop clinical, economic and humanistic value messages for their products - value messages that can help differentiate products and communicate evidence-based value to all market stakeholders.

Create Value Dossiers
We work with our clients to define product dossier outlines and format. Our process to develop dossiers includes thorough literature searches, quality control as we compare information against source documents, professional medical editing, assembly of references, and senior review.

Post-Approval Research
We work with our clients to evaluate their research needs conducted in a post-approval setting, including observational studies and randomized clinical trials. Our outcomes research specialists, with expertise in epidemiology, patient-reported outcomes and survey design, and biometrics, work collaboratively to design studies that meet your scientific, commercial and regulatory needs. We have experience in designing studies that focus on evaluating effectiveness, safety, patient-reported outcomes and medical resource utilization. We specialize in designing commercially-focused observational studies to support value messages for physicians, payers, and patients.

Our services include:

  • Regulatory and Promotional Strategy for Drug Development Programs
    • Outcomes Research Strategic Plans
    • Competitive Landscape Overviews
    • Clinical Trial Design
      • Based on desired PRO or Economic Label Claims
      • Endpoint selection and prioritization
    • PRO Evidence Dossiers
    • PRO Labeling Claim Strategy
  • Product Value Dossiers and Slide Kits
    • Value Messages
    • Global Value Dossiers with Country-Specific Adaptations
    • Reimbursement Dossiers
      • AMCP (Academy of Managed Care Pharmacy)
      • WellPoint
      • NICE (National Institute for Health and Clinical Excellence)
      • SMC (Scottish Medical Council)
      • LFN
  • Disease Overviews
    • Epidemiology and Treatment Pattern Guidelines
    • Burden of Illness (clinical, humanistic and economic)
  • Training in Regulatory Strategy and Value Dossiers

Related Services
For your projects that may have cross-functional requirements, we also offer the following complementary services:

 


 
SENIOR LEADERSHIP

 
Amy Barrett, MSPH, MA
Director, Regulatory and Health Outcomes Strategy
Stephanie Barrows, MPH
Director, Regulatory and Health Outcomes Strategy
Kati Copley-Merriman, MS, MBA
Vice President, Regulatory and Health Outcomes Strategy and Market Access
Melissa Juniper, MS
Director, Regulatory and Health Outcomes Strategy
Shahnaz Khan, MPH
Senior Director, Regulatory and Health Outcomes Strategy
Margaret Mordin, MS
Senior Director, Regulatory and Health Outcomes Strategy

For a full list of scientific staff bios, click here.

 
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CONTACT US
To learn more about our research and consulting services, please call us at:
US: +1.800.262.3011
Spain: +34.93.241.7766
UK: +44(0)161.232.3400
Or email one of our experts directly.
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