Real-World Evidence and Late Phase Research

Operational and consulting expertise

We support the phase 2-3 clinical development of niche treatments, blockbuster drugs, and biosimilars that help save lives. ICON’s dedicated outcomes research experts possess deep knowledge and insight to design your study to meet your specific objectives. We design every study with input from leading epidemiologists, medical and scientific affairs experts, COA authors, KOLs, and access to Mapi Research Trust.

ICON delivers operational and consulting services to achieve product authorisation. We achieve this through the strategic design and delivery of real-world evidence studies and late phase research. Our dedicated late phase research team integrates real-world evidence expertise with specialised operational capabilities. We work hand-in-hand with sponsors with sponsors to design and execute studies that address the unique late phase and RWE demands of regulators, payers, providers, and patients, while positioning your asset for optimal market access. We leverage Clinical Informatics, state-of-the-art technologies, and our global reach to maximise safety and efficiency and make data-driven decisions for every study.

Our functional and therapeutic expertise spans a broud range of indications:

• Oncology, including solid and  haematological malignancies
• Musculoskeletal, gastrointestinal, respiratory, and infectious disease
• Rare diseases
• Cardio-metabolic
• Neurology/psychiatry
• Biosimilars

Comprehensive late phase programs

Our experts provide strategic guidance to build and implement comprehensive, flexible late phase programs and studies worldwide, including:

• Phase 2b and 4 clinical trials
• Disease, product, and patient registry studies
• Safety surveillance studies
• Retrospective data analyses
• Expanded access / Compassionate use / Managed Access programs
• Post marketing safety studies
• Pragmatic clinical trials
• Non-interventional and observational studies
• Chart review studies

Risk-based monitoring

We employ a risk-based monitoring (RBM) approach to holistically evaluate each individual study and determine the right organisational structure to support both central and on-site monitoring and see data trends in real time.

Our Predictivv™ platform supports the complexity of adaptive protocol designs, adaptive trial management, patient-centric recruitment strategies, and risk-based monitoring.

Site identification and selection

80% of clinical trials fail to meet enrolment goals

50% of sites enrol either one or no patients

Selecting the right investigative sites can significantly improve timely enrolment and the quality of data collected. We take a data-driven approach to site selection, evaluating potential sites based on their:

• Access to the patient population
• Research infrastructure
• Past enrolment performance on similar studies
• Demonstrated ability to provide patient data in a timely fashion
• Any potential competing clinical studies at the same site

Once evaluated, we only contact sites that are most likely to be interested in study participation and capable of meaningfully contributing to enrolment, saving sponsors both time and money.

Clinical Trial Liaisons

Our field-based Clinical Trial Liaisons (CTLs) can help increase participation and enrolment in your clinical trials, while also ensuring you receive high-quality data. CTLs are highly trained PhDs, PharmDs, and medical doctors with extensive experience cultivating productive relationships across all key functions of clinical research, from site selection all the way through the clinical trial.

CTLs work with investigators and site staff to accurately project potential enrolment and optimise prescreening strategies, liaise with other departments to ensure data quality is maintained, and engage with non-participating physicians to generate interest in referring patients for your study.

Integrated patient and site engagement

We help identify real patients and the most appropriate research sites through our collaboration with leading EHR providers. Our direct-to-patient contact teams and site management associates ensure that your patients, sites, and investigators are fully engaged throughout the study.