Evidence, Access & Pricing

Evidence Strategy (HEOR)

A dedicated team of Subject-Matter Experts to build evidence, drive scientific and medical education, support value-based pricing and achieve favorable market access

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Proven expertise in high-impact, high-value therapies with high unmet need across Pharma, Biotech and MedTech

Deep familiarity with first-to-market launches, especially in life-saving therapies for pediatric conditions and rare diseases

Creative and impactful evidence generation that differentiates products in crowded, competitive therapeutic areas (TAs)

Stellar track record in conducting RWE studies, successfully bringing them to publication and pull-through to support Market Access and Strategic Pricing

Clear demonstration of prior success in driving access for patients and reducing payer barriers for approval

In today’s global life sciences marketplace, the role and value of evidence is unquestionable. Novel therapies—many of which might be high-value therapeutics and/or specialty drugs—will need compelling evidence to persuade physicians to write the script and payers to provide access to label.

Pre-launch, clients need to characterize the disease landscape, identify unmet needs, create pre-launch medical education and conduct market-shaping activities.

Post-launch, therapies will need to continue to produce evidence of real-world value. Compelling evidence is especially needed in crowded, highly competitive TAs to demonstrate differential value versus other therapies.

Without high-quality evidence, commercial objectives suffer—market access can be sub-optimal, KOL advocacy can be weak and the product’s potential could be severely limited.

Trinity Evidence Strategy helps clients demonstrate the holistic value of their assets across the product lifecycle by leveraging a best-in-class methodological approach powered by technology and scientifically-driven, publication-quality primary and secondary research.

CloudCast Brochure cover

Trinity Evidence Strategy Brochure

With markets growing increasingly competitive across the globe, the challenge for Med Affairs and HEOR teams is four-fold:

Articulate and quantify the holistic value of a product | Differentiate products from competitors and the existing standard of care | Support a strategic price point | Ensure a successful medical communication, market access and reimbursement strategy

Trinity’s Evidence Strategy team offers a complete suite of HEOR and Med Affairs services to help differentiate the value of a product vs. the competition.


Trinity’s HEOR Core Pillars of Excellence

3 areas of deep expertise across 8 core engagement types

Evidence Planning | Evidence Generation and Execution | Scientific Dissemination

Planning: Value Proposition Development and Evidence Planning, Literature Review and Synthesis, KOL ID, Mapping and Engagement | Generation: Qualitative Primary Research, Quantitative Primary Research, including DCEs, Health Economic Modeling, RWE Claims/EHR | Dissemination: PUblications, Value Dossiers, PIE Decks and Objection Handlers

Trinity’s Evidence Strategy team helps clients design a compelling value story, demonstrate must-have evidence and drive scientific dissemination

DESIGN
  • Disease Landscape and Unbranded Value Story Development
  • Value Drivers and Detractors 
  •  Critical Evidence Review and Gap Assessment 
  •  Evidence Generation Plan and RWE Roadmap 
  • KOL Mapping 
  • Publications Planning 
Demonstrate
Disseminate
  • Scientific Publications (abstracts, posters, podium presentations, manuscripts)​
  • PIE Deck / AMCP Dossier / GVDs​
  • Objection Handler

The Evidence Strategy team offers a complete suite of Health Economics and Outcomes Research (HEOR) services to help differentiate the value of a product vs. the competition.  

Leveraging best-in-class, scientifically driven, publication-quality primary and secondary research methods, we help our clients demonstrate the holistic value of their assets across the product lifecycle — from early clinical development all the way to launch and post-launch. 

Explore the Power of a Strong Value Proposition

Providing the right evidence to payers and other key access stakeholders is essential to unlock the pricing and access potential of therapies. 

Find out more about Trinity’s Value services

  • Answering Important Business Questions

    Trinity’s integrated RWE and Evidence Strategy teams have collaboratively helped hundreds of clients address their most important business questions:

    • What are the unmet needs in the current treatment paradigm for Disease X?
    • What is the epidemiology of Disease X? Are there sub-types of interest?
    • How do I identify the right patients in the absence of ICD-9 / 10 codes?
    • What is the patient journey for someone suffering from Disease Y?
    • What are the treatment patterns, therapy use, switch / adherence behaviors?
    • What is the comparative effectiveness of therapies in this market / class?
    • What SE and AE are associated with these treatments?
    • What is the overall Healthcare Resource Utilization (HCRU)?
    • What is the holistic cost of care?
    • Strategically, what are the pain points, unmet needs and gaps where Treatment Z can add value?

    Find out more about Trinity Real World Evidence – Helping clients navigate through the complexities of RWE analysis.

Trinity supports a broad array of high-impact scientific publications

Collaboration between HEOR and Medical Affairs helps organizations optimize value, access and patient outcomes.

Medical Affairs Key Success Initiatives - Value Prop Development & Medical Affairs Strategy, Medical Evidence Generation Strategy and Plan, Scientific Platform Development, RCT Endpoint and/or Site Identification, Field & Speaker Training and Insights Collection, KOL ID, Mapping, Engagement, Scientific Publications & Medical Communications, Medical Education | HEOR: Value Prop Development & HEOR Evidence Strategy, Literature Review & Meta Analyses, KOL ID & Mapping and Engagement on RWE Studies, QUalitative Primary Research, Quantitative Primary Research, Including DCEs, RWE: Claims/EHR, HECON Modeling, Publications, Value Dossiers, PIE Decks & Objection Handlers

An integrated approach to evidence generation is critical to optimize strategic value stories and achieve commercialization goals. A virtuous cycle of evidence generation and value delivery is woven together by insights from randomized clinical trial and real world evidence approaches to produce poignant evidence that meets decision maker needs.


Trinity’s Evidence Strategy team achieves accuracy and confidence in identifying the right patients by using the most appropriate data assets, analytics and analytical rigor to drive the evidence needed, including Trinity’s unique network of direct data access. Trinity’s integrated, tech-enabled approach allows clients to tap into dedicated, experienced HEOR and RWE teams for support:

  • Demonstrate product differentiation
  • Conduct appropriate statistical testing and comparator analyses—including matched cohort/baseline/reference
  • Identify compelling economic evidence to support payer engagement
  • Develop compelling clinical and humanistic evidence to support medical education
RWE in HEOR

Which data sources have the greatest utility for each specific asset?

How—and when—
can they be
leveraged?

How should
they be combined?

What changes in data sources will influence healthcare in the future?

Latest Industry and Scientific Publications

ISPOR US 2024 Research Posters

ISPOR US 2024 Research Posters

Healthcare Resource Utilization of Patients with Short Bowel Syndrome Dependent on Parenteral Support: A Retrospective Claims Analysis AUTHOR(S): Ali A1, Micic D2, Gallivan M1, Kulkarni A3, Henderson J4, Mitchell G4  1Trinity Life Sciences, Waltham, MA, USA, 2University of Chicago Medical Center, Gastroenterology, Hepatology, and Nutrition, Chicago, IL, USA, 3Trinity Life Sciences, Malden, MA, USA, 4VectivBio AG, Basel, Basel, Switzerland […]

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ISPOR EU 2023 Research Posters

ISPOR EU 2023 Research Posters

Implications of the Implementation of the Joint Committee Assessment on Launch Planning for Medical Technologies in Europe Acosta Luis S1, O’Hara M2, Yeh M2 1Trinity Partners, LLC, London, UK, 2Trinity Life Sciences, Waltham, MA, USA The EU-wide Joint Clinical Assessment (JCA) is set to be operational from January 2025. The Trinity team reviewed the available literature […]

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ISPOR US 2023 Research Posters

ISPOR US 2023 Research Posters

Health Equity Frameworks – Healthcare System Actions and Priorities Gulaid A1, Goldman E2, Skaar J1, Dehipawala S3 1Trinity Life Sciences, New York, NY, USA, 2Trinity Life Sciences, Waltham, MA, USA, 3Trinity Life Sciences, Bellerose, NY, USA Health equity has been defined as attainment of the highest level of health for all people, regardless of race, ethnicity, disability, […]

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Latest Evidence Strategy Intelligence

Evidence Generation in a Post-IRA World

Evidence Generation in a Post-IRA World

Since the passage of the Inflation Reduction Act (IRA) in 2022, the pharmaceutical industry has significantly altered how they approach and plan for evidence generation activities to best support product launches and pricing and access negotiations. Leading life science companies are taking proactive steps to adjust how and when they develop evidence and how they […]

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Annual State of Global Market Access

Annual State of Global Market Access

In 2023, the life sciences industry saw key therapeutic advances in sickle cell disease, obesity/weight management, and Duchenne muscular dystrophy, among others, and the continued approvals of therapies with cutting edge mechanisms, including the first CRISPR therapy. While 2022 was characterized by accelerated development processes and the rapid evolution of therapeutic standards, 2023 featured increased […]

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The Implementation Game: The Inflation Reduction Act Medicare Drug Price Negotiation Program Guidance 

The Implementation Game: The Inflation Reduction Act Medicare Drug Price Negotiation Program Guidance 

Trinity’s Take Introduction Since the Inflation Reduction Act (IRA) was signed into law in August 2022, biopharma stakeholders have noted the high likelihood of the legislation being challenged in court alongside many questions about how some of the new CMS programs would function. The Medicare Drug Price Negotiation Program is one IRA program expected to […]

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Generating Robust Insights to Develop a Compelling Value Story with RWE

Generating Robust Insights to Develop a Compelling Value Story with RWE

The unprecedented availability of rich RWE data sources gives HEOR, Value and Access and Medical leaders the opportunity to be more intentional than ever before. High-quality, compelling evidence is now a necessity, not just for high-value therapies playing in the rare disease space—but also more broadly, to show reduced unmet needs, health care resource utilization […]

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Our Team

Trinity’s Evidence Strategy team features advanced degrees including multiple PhD-level experts – we consistently deliver high-quality insights and products to meet internal and external stakeholder needs. 

Meet Our Evidence Strategy Experts

The team is led by an Nandini Hadker, an Economist who presents annually at ISPOR, ISPOR-EU, AMCP, AMCP-Nexus and strategic clinical conferences who has authored numerous white papers, academic research posters and peer-reviewed manuscripts in reputed journals.  

Nandini Hadker is supported by Matt O’Hara, who is also a leader in the evidence generation and HEOR space and brings deep expertise in the sphere of HEOR, evidence generation and scientific dissemination. 

If you have any questions, we’re here to answer them.
We look forward to helping identify solutions for you.