Make Informed, Evidence-Based Decisions with RWD Analytics & RWE Modeling

Synapmed’s expert team analyzes Real World Data (RWD) and Real World Evidence (RWE), helping life sciences companies answer key regulatory questions and optimize treatment development strategies. Our AI and advanced analytics-driven approach and predictive modeling provide clear, data-backed insights that demonstrate the safety and efficacy of your therapies. With our comprehensive support, you’ll streamline regulatory submissions and build stronger credibility with regulatory agencies, increasing your chances of faster approvals and sustained compliance with ever-evolving standards.

Tailored HEOR and RWD/RWE services to support your objectives

 Synapmed combines industry expertise with advanced data analytics to offer tailored Health Economics and Outcomes Research (HEOR) and real-world data services. From economic modeling to health technology assessments (HTAs), we provide comprehensive support that helps clients navigate market access, regulatory challenges, and strategic decision-making. Explore the use cases below to see how we turn RWD-driven insights into actionable strategies that drive results.

Unlock the potential of real world data (RWD) and real world evidence (RWE) to inform regulatory decision-making and enhance drug development processes

  • Identify and access high-quality real world data sources, such as electronic health records, claims data, and patient-generated data
  • Manage and analyze real world data with state-of-the-art tools and techniques, ensuring comprehensive data curation, processing, and visualization
  • Design and execute observational studies and randomized controlled trials to generate high-quality evidence that supports drug development

Expert guidance to seamlessly integrate RWD/RWE into drug development programs and optimize clinical outcomes

  • Conduct a comprehensive assessment of the RWD/RWE landscape to identify relevant data sources and understand potential limitations
  • Develop a customized RWD/RWE strategy that aligns with business objectives, identifying opportunities for effective use throughout the clinical development lifecycle
  • Provide regulatory support to ensure RWE generation meets regulatory requirements for drug development and commercialization

Maximize the value of real world data through meticulous management and insightful analysis

  • Ensure the highest quality of real-world data through careful curation, cleaning, and standardization
  • Utilize advanced analytics tools to analyze real world data and identify trends that inform drug development and regulatory decision-making
  • Present findings through clear data visualization, offering comprehensive reports that highlight actionable insights

Enhance regulatory submissions with high-quality real world evidence to support drug development and approval

  • Use RWE to provide additional evidence for label expansion, demonstrating safety and efficacy in new patient populations
  • Supplement clinical trial data with real-world insights, showcasing long-term safety and effectiveness
  • Monitor post-marketing safety and effectiveness through real world evidence to ensure ongoing compliance and safety monitoring

Design and execute studies that generate high-quality RWE to inform critical drug development decisions

  • Collaborate with clients to create studies that address key scientific and regulatory questions, ensuring robust study designs
  • Perform advanced statistical analyses to generate reliable real-world evidence and address potential biases in observational studies
  • Conduct sensitivity analyses to verify findings and provide regulatory support throughout the RWE generation process

Facilitate access to high-quality real-world data sources tailored to specific project needs

  • Collaborate closely with clients to identify the most appropriate real world data sources based on project requirements
  • Evaluate identified data sources for relevance and reliability, ensuring that selected sources meet project needs
  • Navigate complex data access requirements, including compliance with relevant regulations and data security protocols

Ensure compliance with regulatory standards through expert guidance and support during the RWE generation process

  • Assist clients in navigating the complex regulatory landscape surrounding the use of real world evidence
  • Provide insights into regulatory requirements to ensure that RWE generated is robust and can be effectively utilized in submissions
  • Offer strategic advice on integrating RWE into drug development programs to enhance compliance and successful outcomes

Leverage real world evidence to inform market access strategies and reimbursement decisions

  • Analyze real world data to support value propositions and demonstrate the effectiveness of treatments in diverse patient populations
  • Develop comprehensive evidence packages that address payer requirements and facilitate market access
  • Utilize RWE insights to refine pricing strategies and optimize reimbursement opportunities

why synapmed?

Synapmed’s RWD/RWE analytics and HEOR services provide pharmaceutical companies with essential support in managing real-world evidence and health economic outcomes. Our advanced AI technology and team of experts simplify the complexities of data management, study design, and regulatory compliance. With tailored solutions that enhance operational efficiency, we help clients strategically integrate RWE into their drug development programs, optimize market access strategies, and communicate product value effectively. With Synapmed’s unwavering commitment to accuracy, compliance, and strategic insight, you can focus on what matters most: advancing healthcare innovation and improving patient outcomes.

Frequently asked questions

What is HEOR data, and why is it important in healthcare?

HEOR data, or health economics and outcomes research data, provides critical insights into the economic value and clinical effectiveness of healthcare interventions. This data is essential for stakeholders, including payers, providers, and pharmaceutical companies, as it informs decision-making and supports the allocation of healthcare resources.

HEOR studies can include cost-effectiveness analyses, budget impact models, patient-reported outcomes assessments, and health technology assessments (HTAs). These studies evaluate the economic implications and health outcomes of medical interventions.

HEOR data plays a critical role in shaping healthcare policy and reimbursement decisions by providing evidence of the value and effectiveness of treatments. Policymakers and payers use this data to determine coverage, pricing, and formulary inclusion.

RWD analytics and RWE modeling involve analyzing real-world data to gain insights into treatment effectiveness and patient outcomes. These methods are crucial for pharmaceutical companies, as they inform product development, market access strategies, and regulatory submissions by showcasing real-world evidence. payers use this data to determine coverage, pricing, and formulary inclusion.

HEOR services evaluate the economic impact and clinical effectiveness of healthcare interventions. By providing cost-effectiveness analyses and budget impact models, HEOR services help pharmaceutical companies communicate the value of their products to payers and stakeholders.

RWD analytics and RWE modeling utilize a variety of data sources, including electronic health records, insurance claims, patient registries, and surveys. This diverse data provides a comprehensive understanding of treatment patterns and patient outcomes in real-world settings.

RWD analytics and RWE modeling can significantly enhance regulatory submissions by providing real-world evidence that demonstrates a product’s effectiveness and safety. This evidence is essential for satisfying regulatory requirements and improving the chances of approval.

Synapmed adheres to stringent regulatory guidelines and industry standards in its RWD, RWE, and HEOR services. Our quality assurance processes include expert reviews, ongoing training, and adherence to best practices to ensure all analyses are accurate and compliant with regulatory expectations.

Synapmed provides customized solutions by working closely with clients to understand their specific challenges and objectives. We adapt our methodologies and analyses to address unique requirements, ensuring that our insights are relevant and actionable for their product strategies.

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Real World Data (RWD) vs Real World Evidence (RWE)

Real World Data (RWD) and Real World Evidence (RWE) offer significant opportunities and challenges for pharmaceutical companies. RWD, derived from everyday patient product usage through channels such as electronic health records and social media, provides valuable insights into diverse populations, particularly post-marketing. While randomized clinical trial data remains the gold standard, regulators acknowledge RWD’s potential to enhance safety assessments. However, challenges like a lack of standardization in data collection and privacy concerns persist. The FDA addresses these issues through technologies like the My Studies App, which integrates data from various sources to improve patient care and reduce financial risks.

Dedicated to youR Projects

No matter the size or scope of your projects, you have a committed partnership team with Synapmed. A team that listens, pays attention to details, and brings smart insights to the table. All so you can solve real problems throughout the product development and commercialization lifecycle.