Non Interventional, Observational Research

Non-Interventional, Observational Research

Regulatory agencies, payors, policy makers and consumers are increasingly demanding more information on the safety profile and effectiveness of products in the real world setting.  The increasing demand for data that cannot be derived from traditional phase III clinical trials results in the need to expand the reach of current research efforts into peri- and post-approval programs. 

Post-approval, observational studies have unique scientific and strategic objectives, and can be used to address questions pertaining to safety, risk management, effectiveness, actual use and treatment practices.  ICON is experienced in the design and implementation of these studies, capitalising on the opportunity to collect real-world data with a focus on maximising the return on investment for multiple stakeholders.  We are experts working with sponsors, investigator sites, thought leaders and practicing physicians in the design and the global operational delivery of observational studies.  With study designs that range from complex, multi-faceted to streamlined programs that aid the understanding of real-work product use, medical practices and treatment patterns, we leverage deep scientific and operational expertise combined with the expansive global, full service capabilities at ICON to ensure successful delivery for every opportunity.

Our success is a reflection of our ability to direct client product research and positioning needs by conducting practical, credible, and meaningful outcomes research.  To date, we have enrolled over 2,000,000 patients in observational studies, and understand the profound impact this type of data has on adding to the scientific body of knowledge, and ultimately overall public health.

Tailored Suite of Services for Observational Research

ICON has developed a suite of service offerings tailored for study conduct in this space including:

  • Disease or Patient Registries
  • Product Registries
  • Exposure Registries including Pregnancy and Infant Follow-up Studies
  • Ongoing assessments of outcomes and effectiveness in real world patient setting
  • Physician Education

Pregnancy Registries

There are a growing number of products requiring information related to the risk of exposure during pregnancy and the subsequent fetal outcomes.  We provide consultative services around study design, CRF development, operational methodologies, analysis and publication services specifically developed to address the unique aspects of these observational studies including:

  • Sample size 
  • Multiple data sources – (primary care physician/specialists, OB/GYN, Pediatrician) 
  • Case control studies 
  • Regionally aligned centralised operational model 
  • Patient recruitment and retention 
  • Longer term infant follow-up (generally through age 3) 
  • Signal detection
  • Advisory Board oversight 
  • Full range of publication services 

Operational Expertise

Our approach is tailored to meet the objectives of multiple stakeholders while considering the challenges specific to observational research.  ICON offers operational expertise from study start-up through final reporting.  In the centralised operational model, the main primary point of contact for sites has shifted from the more traditional traveling CRA to a cost effective, specialised in-house monitor located in regional hubs and who is readily available for sites during business hours.

Research naïve sites in late phase research primarily, appreciate and value the flexible site support, uninterrupted by travel time. Our hubs cover more than 35 different languages and have a global footprint, with a regional presence across North America (Durham, NC), Latin America (Mexico City), Europe (Warsaw, Barcelona and Paris) and Asia Pacific (Beijing, Tokyo and Seoul). They utilize a state of the art phone technology system that allows inbound and outbound site as well as patient outreach contacts to be tracked and routed in the most cost effective manner generating operational and financial efficiencies across individual projects and programs overall. Our global staff is highly skilled and cohesively implement studies worldwide, providing an extensive range of services including:

  • Strategic, scientific consultation 
  • Study design 
  • Global study start-up
  • Site identification and recruitment
  • Regulatory and EC/IRB submissions, contract negotiations. Investigator payments
  • Materials development 
  • Centralized Site Management 
  • Site Monitoring
  • Late phase technology solutions
  • Statistical analysis
  • Cross-functional project management
  • Scientific Advisory Board communication and management
  • Report production and publication generation
  • Leveraging global expertise across ICON: Data Management, Safety, Medical Monitoring, Central Labs, IVRS/IWRS, Medical Writing, Contract Staff