For a successful product development strategy, you need to prove value to a wide range of stakeholders, including regulators, payers, providers, and patients. As the demand for evidence in real-world settings increases, it is critical to understand how to incorporate real-world evidence (RWE) at every stage of your drug or device development journey.
You can have confidence in our experts to help you develop robust real-world evidence strategies and conduct scientifically rigorous research to support every aspect of your evidence-generation program—from market access, outcomes research, patient preference, and economic evaluation, to reimbursement and safety activities. We start with your research questions and help develop the right strategy to utilize RWD.
Our experts have collected and analyzed prospective and retrospective real-world data (RWD) for decades and stay informed on evolving methods and guidelines to provide you with knowledgeable and relevant support and advice. We can help you understand what RWE guidelines mean for your product and help you develop a robust approach to utilizing real-world data for every stage of your drug or device development journey.
Our diverse background in clinical research, regulatory submissions, epidemiology studies, and drug, vaccine, and medical technology safety and effectiveness enables us to align the right approach with your objectives. Based on your needs, we can provide consulting support for specific projects or can set up long-term arrangements that allow access to specific experts on an ongoing basis.
Strengthen safety, validate efficacy, and fulfill regulatory obligations with post-authorization studies that help you sustain market success
Estimate cost and timeline requirements, assess institutional review board (IRB) needs, and determine eligibility criteria, patient availability, site capacity, and data source reliability
Ensure rigorous scientific validity, seamless regulatory alignment, and operational efficiency from day one
RTI-HS transforms real-world data into actionable evidence through database and registry research that supports regulatory, clinical, and market decisions.
Explore how our experts can help you answer key questions about treatment effectiveness and safety, disease burden and progression, healthcare resource utilization and costs, or patient outcomes in real-world settings.
Leverage databases for health economic and pharmacoepidemiology research, enhancing safety assessments, and treatment effectiveness studies
Unlock real-world insights with patient registry research to inform regulatory decisions, support market access, and drive better health outcomes
Use real-world evidence to efficiently and credibly evaluate novel treatments
Ensure rigorous scientific validity, seamless regulatory alignment, and operational efficiency from day one
Comprehensive management of pharmacoepidemiologic investigations from planning through delivery
Estimate cost and timeline requirements, assess institutional review board (IRB) needs, and determine eligibility criteria, patient availability, site capacity, and data source reliability
Capture current disease prevalence, treatment modalities, and risk factors to enrich your real-world evidence for dossiers and support regulatory applications
Leverage the power of longitudinal studes to understand changes in health, treatment response, and real-world outcomes over time
To meet the requirements of risk management programs, inform drug development and post-approval strategies, or answer epidemiologic questions, we can help you design and implement real-world evidence research using primary data collection—including cohort studies and surveys of patients, physicians, or caregivers.
Depending upon your research question, we work with you to identify and operationalize an efficient and effective design to yield the answers you need within your budget and timeline. Our services support all aspects of primary data collection for observational studies or secondary collection of chart data requiring special protection.
Combine the rigor of in-person clinical assessments with deep patient insights gathered through structured surveys
Our broad range of experience and research collaborations make us an ideal research partner for pharmacoepidemiology studies. Members of our team of epidemiologists are often invited as advisors on steering and advisory committees convened by clients, research partners, governments, and academic organizations.
Our research collaborations enable us to combine multi-country real-world data, methodological rigor, and transparent regulatory-grade evidence to accelerate accurate safety and effectiveness insights, enhance credibility, and drive faster market adoption for new therapies.
Comprehensive management of pharmacoepidemiologic investigations from planning through delivery
What is real-world evidence strategy, and why is it important in product development?
Real-world evidence refers to data collected from real-world (i.e., nonrandomized) settings, such as enrolling patients into specific studies (primary data collection) or patient records (e.g., electronic medical records), clinical practice, administrative sources (e.g., health insurance claims), and registries (secondary data collection). It is crucial for demonstrating the value of a drug or device to various decision-makers, including patients, regulators, payers, and providers, particularly in areas like safety, effectiveness, market access, and reimbursement.
How can RTI Health Solutions (RTI-HS) experts help with real-world evidence strategy and research?
Our experts have decades of experience collecting and analyzing both primary and secondary real-world data. We strive to stay current on evolving methods and guidelines to provide informed advice and strategies tailored to your medical product research and development needs.
What does a real-world evidence strategy entail?
A real-world evidence strategy involves developing a robust approach to utilizing real-world data throughout a product’s life cycle. Our team helps build strategies for development, market access, outcomes research, patient preference, economic evaluation, reimbursement, and postapproval safety activities to ensure successful product development and launch.
How does a real-world evidence strategy support early product development decisions?
Real-world evidence provides critical insights into where your drug or device fits within the treatment landscape. It helps inform study designs that demonstrate the product’s comparative effectiveness, safety, and value, laying the foundation for further clinical research and regulatory approval.
How can RTI-HS assist in maximizing clinical research programs with real-world evidence?
External control arms based on real-world data can be essential in product development activities as comparators for single-arm trials, especially in rare diseases, and in general for open-label extension trials. Our team helps build integrated research strategies that use real-world evidence strategies to efficiently demonstrate product value to payers and ensure access for patients, caregivers, and healthcare providers. We aim to provide a cost-effective path for your clinical research programs.
How does real-world evidence support regulatory approval and reimbursement plans?
Real-world evidence plays a key role in meeting the growing demands of regulatory authorities, risk management programs, pharmacovigilance, and value-based reimbursement plans. Our team helps ensure that your evidence package is robust and comprehensive, supporting regulatory submissions and securing reimbursement for your product at launch.
How can real-world evidence help with managing an established product?
For postauthorization, real-world evidence helps understand a product’s use and effect in real-world, routine clinical practice. We have extensive experience designing and implementing real-world evidence studies to evaluate safety, effectiveness, value, and potential label expansions after product launch.
What are some examples of RTI-HS's work with real-world evidence?
Our case studies showcase our extensive experience in developing and applying real-world evidence strategies to a variety of medical products. These examples highlight our ability to design evidence-generation programs that meet the needs of regulators, payers, and healthcare providers.
How can real-world evidence be used to inform reimbursement decisions?
Real-world evidence is essential in demonstrating the long-term value of a product, especially for payer and reimbursement decisions. Our team helps create data-driven strategies that show your product’s real-world effectiveness, improving the likelihood of reimbursement approval.
What types of real-world data do you use in your evidence strategy?
We use a variety of real-world data sources, including patient registries, electronic health records, administrative health insurance claims data, patient surveys, and other publicly available data. These data sources are integrated to create comprehensive, scientifically rigorous evidence to support your product development, safety, and market access strategies.