The Product Lifecycle: - ICON plc

The
Product
Lifecycle:
Strategic Consultancy
& Services
ICON’s Lifecycle Sciences group offers the full range of
services to assist our 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.
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
1

Clinical Research
Pre-clinical Phase l Phase ll Phase lll Phase lV Post Approval
Product Portfolio Review
Clinical Development Support
Phase lV and Observational Research
Scientific and Medical Communications
Our experienced staff work collaboratively to support the global research and positioning
needs of our clients throughout the product lifecycle, beginning with Product Portfolio Review.
Product Portfolio Review
ICON’s Lifecycle Sciences group 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 caregiver 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?
Challenge:
Our client wanted to identify the burden of illness and
the economics for a product in development for the
acute conversion of Atrial fibrillation (Afib), a common
but potentially serious condition.
Solution:
• Developed a Health Economic strategic development plan,
including specific recommendations for future research to
be conducted.
• Conducted a health economic landscape assessment of Afib.
• Completed an assessment of the feasibility of utilizing different,
existing data sources to estimate the cost of treating Afib,
and evaluate the reimbursement landscape surrounding the
management of this condition.
• Conducted an analysis of an administrative and hospital database
to estimate treatment costs, length of stay, and adverse events in
Afib patients treated in various inpatient and outpatient settings.
• Prepared several conference presentations and a manuscript to
support findings.
• Developed a budget impact model and supporting content for the
AMCP dossier for the product.
2

Clinical Research
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 Research
We 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
• Administrative Claims Analyses
• Reimbursement Support
• Decision-Analytic Models
• Comparative Effectiveness Studies
• Non-interventional Phase IV Clinical Trials
• Educational Interventions for Providers or Patients
• Post-Hoc Analysis of Registrational Studies
Challenge:
Our client wished to submit a PRO claim (to be submitted
to the FDA) related to patient reported symptoms associated
with an investigational therapy. The PRO instrument was
selected for the Phase III trial prior to Lifecycle Sciences
group involvement.
Challenge:
Our client asked Lifecycle Sciences group to evaluate
an educational intervention to improve compliance
with treatment guidelines for patients receiving care at
community-based oncology practices.
Solution:
• Provided strategic consulting for obtaining a PRO label
• Developed the conceptual model, endpoint model, and
conceptual framework to support the instrument selection
• Conducted targeted literature searches
• Convened several Scientific Advisory Panel meetings to review
study materials
• Adapted, validated, and pilot tested the instrument to be used in
the clinical trials
• Conducted the statistical analysis of the PRO data
• Developed a comprehensive PRO dossier for submission to
the FDA
Solution:
• Provided strategic consulting on study design and
implementation, including design of the chart review study
pre- and post-intervention
• Assisted with development of protocol and case report forms
(CRFs) for both pre- and post-intervention data collection
• Trained and provided oversight to chart abstractors who
abstracted data pre- and post-educational intervention
• Managed data collection
• Developed the statistical analysis plan and analyzed the data
• Developed multiple abstracts and a published manuscript
3

Clinical Research
Scientific and Medical Communications
Expertise you can trust
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 customized for our client needs and
individual studies, ranging from providing analysis guidance for
scientific advisors to conducting analyses and writing manuscripts.
Publication Support :
Scientific Advisory Boards
ICON Clinical Research is a division of ICON plc which specializes
in the planning, management, execution and analysis of Phase
IIB-IV clinical trials, ranging from small studies to complex
multinational projects.
Innovation, high quality solutions and excellent customer service
are the foundations of our Lifecycle Sciences group. We provide
comprehensive and strategic support to our clients throughout
the project lifecycle with three distinct yet complementary
departments: Health Economics & Outcomes Research, Statistics
& Data Operations, and Project Operations which support our
highly strategic, flexible and high quality delivery of projects.
We view our clients as strategic partners and understand that
each interaction our team has is an opportunity to build upon
and strengthen relationships, drive business results, and ensure
quality. Our customer-focused model allows our team to be
proactive, identifying and implementing solutions while providing
an exceptional level of client service.
Manuscript / Abstract:
Content Development,
Editing, Submission,
Product Dossiers
Statistical Consulting
Programming
Quality Control
Our approach is uniquely tailored to meet the objectives of
multiple stakeholders . ICON’s Lifecycle Sciences group has a
commitment to quality in all communications and deliverables,
and in today’s rapidly changing environment, one constant is the
depth, breadth, and commitment of our staff.
About ICON plc
ICON plc is a global provider of outsourced development services to
the pharmaceutical, biotechnology and medical device industries.
The Company specializes in the strategic development, management
and analysis of programs that support clinical development - from
compound selection to Phase I-IV clinical studies. ICON currently has
over 7,000 employees, operating from 71 locations in 38 countries.
ICON plc Corporate Headquarters
South County Business Park
Leopardstown
Dublin 18
T: +353 1 291 2000
F: +353 1 291 2700
E: info-lifecycle@iconplc.com
ICON Clinical Research US
212 Church Road
North Wales
PA 19454
T: +1 215 616 3000
F: +1 215 699 6288
E: info-lifecycle@iconplc.com
www.iconplc.com
ICON has offices located throughout the world. For more information
on local offices please visit www.iconplc.com
V1: 05/2009