ICON Medical & Safety Services - A symbol of excellence

ICON is a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. Specialising in the strategic development, management and analysis of programs that support clinical development - from compound selection to Phase I-IV clinical studies - ICON has the expertise to conduct clinical trials and development projects locally and globally. ICON provides development services on a stand-alone basis or as part of an integrated 'full service' solution.

ICON offers a broad range of specialised services to assist pharmaceutical, biotechnology and medical device companies to bring new drugs and medical devices to market faster.

Adaptive trials

ICON offers design, simulation and execution of adaptive clinical trials. We are the only CRO that offers the knowledge, software, systems and global footprint to make global adaptive trials a reality. ICON has:

  • more than a decade of experience in successfully planning and managing nearly 200 adaptive clinical trials for over 30 sponsors
  • experts with direct involvement in regulatory agency adoption of adaptive design trials and subsequent agency guidance
  • operational teams and technologies to apply the power of adaptive techniques to drug and medical device trials.

Clients also have access to the ICON Adaptive Trial Innovation Centre, a group of world-leading experts in adaptive design and execution that provide leadership in these key areas:

  • design, simulation and execution of adaptive trials across all phases of development
  • development of innovative trial methodologies
  • customised training in adaptive trial statistical methodology
  • advice and guidance on the logistical and operational requirements for successful adaptive trial execution.

Preclinical/Phase I

ICON specialises in the strategy and delivery of early-phase clinical development services to enable informed, timely decision-making for our clients. With expertise in early phase clinical research, bioanalytical, PK/PD modelling and simulation, and the full range of supporting services, we incorporate scientific excellence and product development strategy in all that we do. Our multi-disciplinary experts have the experience to address the most demanding drug development challenges with an unyielding focus on completing projects on time, on budget and with the quality that will withstand the most vigorous scrutiny.

Key services include:

  • product development consulting
  • bioanalytical
  • PK/PD modelling and simulation
  • population PK
  • data analysis (TK, PK, PK/PD)
  • regulatory affairs strategy/submission
  • protocol design
  • medical writing
  • quality control/assurance
  • pharmacodynamic models
  • clinical studies including: food effect studies; dosage Regimen assessments; diabetic Clamp studies; QTc studies; first in man, dose escalation, PK/PD; multiple dose studies; drug interaction studies; bioavailability, bioequivalence; Phase I patient studies; special population studies; patient studies; proof of concept studies.

ICON's customised services can be deployed as stand-alone or part of an integrated full-service solution to support global and locally managed projects.

Phase II-III

ICON specialises in the planning, management, execution and analysis of Phase II-III clinical trials, ranging from small studies to complex, multinational projects.

  • clinical operations
  • medical and safety services
  • data management
  • biostatistics
  • interactive technologies
  • clinical development support
  • product portfolio review
  • scientific and medical communications.

Commercialisation and outcomes

ICON's commercialisation and outcomes practices provide insights to clients on strategies and execution for long-term value through customised engagements that fit the compound, the company and the market, maximising products' success and their benefits to patients' health. Speciality practices directed toward product commercialisation include: peri-approval and observational research; pricing and market access, health economics; patient reported outcomes; epidemiology; electronic clinical outcomes assessment; language services; and medical device and diagnostic research services.

Medical device trials

ICON's dedicated medical device team understands the unique requirements of medical devices and diagnostics. Our medical device experts provide strategic support and tactical solutions for traditional devices, in vitro diagnostics, and software devices. Services include:

  • Medical device strategy and market access - expertise to guide new product development and product/portfolio enhancements, including support for pharma clients seeking to expand into medtech with combination products and companion diagnostics.
  • Product lifecycle expertise -consultancy services and support throughout the product life cycle including: commercialisation and reimbursement planning; strategic regulatory consulting; quality systems development and implementation; clinical evaluation development and study construct; regulatory submissions and dossiers; post market surveillance, post market activities to support future product enhancements and entry to new markets.
  • Comprehensive clinical operations - global services in the US, Europe, Asia and South America to address all aspects of medical device product clinical development, supporting all studies from first-in-man to large-scale post marketing programs. Services offered include: study management from in-house teams or resourcing; imaging, data management, e-solutions; lab services, safety and CEC management; medical writing; auditing and QMS.

Products and Services

Contact Details

ICON Medical & Safety Services
Contact: ICON Medical & Safety Services
URL: www.iconplc.com

Adaptive design trials – ICON is the only CRO that offers the knowledge, software, systems and global footprint to make global adaptive trials a reality.
Medical device services – ICON understands the unique requirements of medical device and diagnostic development.
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