Product/Service

Product Lifecycle Consultancy Services

Source: ICON

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ICON’s Lifecycle Sciences group offers the full range of services to assist clients with activities throughout the product lifecycle.

Our scientific and operational expertise begins with pre-clinical product planning and includes clinical development support (Phases I–III), full-service post-approval research (Phase IV and observational), and scientific and medical communications.

ICON’s Lifecycle Sciences group offers the full range of services to assist clients with activities throughout the product lifecycle.

Our comprehensive expertise is both scientific:

• Health Economics
• Outcomes Research
• Epidemiology Research
• Observational Research (including registries and safety surveillance)
• Phase IV Research (large simple trials)
• Statistical Analysis
• Scientific and Medical Communications
 

And operational:

• Study Start-Up
• Site Recruitment and Site Monitoring
• Development of Study Materials
• Global Site Management
• Targeted Data Management
• Data Collection (including EDC, ePRO, and paper)
• Statistical Programming
• Project Management
• Help Desk for Patients and Sites
• Custom Technology Solutions
• Scientific Advisory Boards

 

 

 

 

 

 

 

 

 

Product Portfolio Review

ICON’s can answer a range of questions that may arise during product portfolio review using a variety of approaches, including retrospective studies, economic modeling, literature review, and expert interviews:

    What is the patient or care giver burden of illness?
    What is the cost of existing treatments?
    What is the potential impact of a new drug on costs of treatment?
    What are the current provider practice patterns for this disease?
    What is the current reimbursement environment for a potential product?
    What is the impact of regional and national policy on product adoption?
    What economic and patient reported outcomes are likely to be needed?
    What is the potential impact of alternative pricing or reimbursement plans?

Clinical Development Support

Patient-reported data is an important source of information in registration studies. We provide multiple services supporting Phase I–III global clinical trials:

  • Development and Validation of Patient Reported Outcomes (PROs)
  • Translation and Cultural Adaptation of PROs to be included in clinical trials
  • PRO dossier and document submissions for the FDA
  • Selection of Endpoints for Patient or Economic Outcomes
  • PRO Data Collection (electronic and paper)
  • Data Analysis of PRO and Economic Endpoints
  • Site Support for PRO data collection
  • ROC analysis for PMAs

Post-Approval Resesarch

ICON can provide advice and operational support for clinical and commercial activities after drug registration in the following areas:

•Product Registries
•Community Surveys
•Epidemiologic Studies and prospective Disease Registries
•Safety Surveillance
•Retrospective Chart Reviews
•Post-Hoc Analysis of Registration Studies
 
• Administrative Claims Analyses
• Reimbursement Support
• Decision-Analytic Models
• Comparative Effectiveness Studies
• Non-interventional Phase IV Clinical Trials
• Educational Interventions for Providers or Patients
 

Scientific & Medical Communications

ICON’s Lifecycle Sciences group has an enviable track record for successful analysis, publication, and presentation of our research findings on behalf of our clients, with hundreds of publications in peer-reviewed journals and hundreds of presentations at scientific and industry meetings.

We also prepare reimbursement dossiers and Global Value Dossiers to provide information on product value. Our senior staff, who are actively involved in research and have previous or current academic affiliations, partner with multidisciplinary experts to develop publication and analysis plans.

Communications support is customised for our client needs and individual studies, ranging from providing analysis guidance for scientific advisors to conducting analyses and writing manuscripts.