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:
