Real World Study Designs
Flexible study designs across the real world evidence spectrum
Study designs that deliver regulatory, payer, and clinical impact
Our integrated portfolio of non-interventional and interventional study designs across 20+ therapeutic areas enables sponsors to generate credible, decision-ready evidence across the full product lifecycle—while minimising site burden and operational risk.
Every real world study begins with a clear understanding of the decision it needs to support. ICON designs studies that are tailored to the research question, data landscape and stakeholder requirements. We consider:
Regulatory and HTA expectations
Data availability and quality
Feasibility across geographies and sites
Patient journey and care pathways
Operational complexity and timelines
*May 2020 – May 2025
Therapeutic area experience
We deliver the full spectrum of real world study designs, executed at global scale and informed by experience across 20+ therapeutic areas.
Our therapeutic expertise includes obesity, ophthalmology, dermatology, cardiovascular, oncology/haematology, infectious diseases, central nervous system, rare & orphan diseases, respiratory, and internal medicine & immunology.
Global footprint of RWE team ensures a scalable partnership
Our global team of 950+ highly experienced RWE and Health Economics and Outcomes Research (HEOR) professionals along with dedicated real world research project directors, project managers, and clinical trial managers provide services in over 60 countries.
Whether you're launching a country level project or scaling across regions, our operational model supports adaptive engagement. Our holistic approach to resource allocation will be based on active study demands and forecasted needs for upcoming studies.
Volume in studies and services bring inherent efficiencies both in process and strategic allocation of resources. ICON is fully committed to unlocking the value of partnering on programs of any size and scale through planning, resourcing, and implementing innovations and alternative approaches to study delivery.
Operational model for delivering real world studies
Fit for purpose study delivery
Real world studies require distinct operational approaches compared with traditional randomized trials. Dedicated start-up teams, adaptive monitoring models, and flexible site engagement strategies support:
- Rapid study start-up and execution
- Reduced investigator and site burden
- Engagement of prescribers and non-traditional research sites
- High-quality data generation at scale
Operational models are tailored to study objectives, geographic scope, and evolving evidence needs.
Accelerating study start-up activities
Start-up requirements for real world studies are highly diverse and tailored to the specific objectives outlined in each protocol. These studies often demand a distinct approach compared to traditional clinical trial phases, with a focus on prescribers, standard-of-care assessments, and sites that may lack prior research experience.
Recognizing this need, ICON has established a dedicated Real World Solutions start-up team equipped with specialized expertise and advanced tools. This team facilitates rapid study initiation, implements fit-for-purpose regulatory strategies, minimizes site burden, and provides proactive support to investigators - ensuring efficient and effective study execution.
Monitoring and site management approach
Every study is unique. ICON applies a flexible, fit‑for‑purpose approach tailored to study‑specific requirements. Our site management and monitoring model, Research Services Hubs, is designed to align with the realities of real world research, including Phase 3b and both non‑interventional and interventional Phase 4 studies.
This model provides investigators and research teams with the right level of support, reducing burden, improving engagement and sustaining performance throughout the study lifecycle.
ICON designs real world studies that are not only methodologically sound, but practical to execute and valuable to stakeholders.
Connect with us to explore how ICON can support your real world study design needs.