Industry Provider Profiles Company Type Services
Outcome, the real-world and late phase research company of Quintiles, is the global market leader in patient registries, observational research, post-approval studies, interventional phase IIIB and phase IV trials, data, and integrated technologies for evaluating real-world outcomes. We provide services and technologies focused on evaluating the safety, effectiveness, value, and quality of healthcare products, therapies, and services. Our teams have designed, developed, and managed an industry-leading number of real-world studies, including many of the largest and most well-recognized programs for disease outcomes, effectiveness, safety, and risk management. In addition to working with life sciences companies, we also partner with many providers and healthcare organizations, specialty associations, hospital associations, pharmacist associations, managed care organizations, state departments of public health, Quality Improvement Organizations (QIOs), and government agencies. In fact, nearly 2,500 healthcare organizations are our direct customers.
We are also actively involved in supporting federal initiatives in regulating and promoting post-approval research. Outcome is leading the Good ReseArch for Comparative Effectiveness Initiative (GRACE Principles), an effort to develop best practice principles for the design and conduct of observational studies of comparative effectiveness. Outcome is also an Agency for Healthcare Research and Quality (AHRQ) DEcIDE Research Center, through which Outcome led the development of the first and second editions of the handbook “Registries for Evaluating Patient Outcomes: A User’s Guide.”Outcome also serves as a research center for the European Medicines Agency (EMA) ENCePP project, focused on enabling the commission and implementation of PASS by healthcare stakeholders that may provide further insight into the benefit-risk balance of marketed products in Europe. Additionally, Outcome is a partner for the EMA PROTECT-EU project, a multinational collaboration of 29 public, private and academic organizations that have come together to develop innovative methods in pharmacoepidemiology and pharmacovigilance.Programs
We design and implement the following
programs:
Patient Registries of Products, Therapies, Diseases, and/or
Services
Post-Approval and Phase IV Studies
Observational Studies
Phase IIIb/Expanded Access
Quality Measurement and Improvement Initiatives
Benefit Risk Management/RiskMAPs/REMS
Safety & Surveillance
Health Outcomes/Health Economics
Quality of Life/Patient Reported Outcomes
Patient Retention (Adherence/Persistence/Compliance)
Performance Tracking Systems
Instrument Validation Studies
Controlled Distribution Programs
Health Interventions (e.g. Cluster Randomized Studies)
Performance-Linked Access Systems
Comparative Effectiveness
Our areas of focus include:
Products (Drug or Medical Device)
Healthcare Services (Including Procedures)
Diseases or Conditions
Exposure
Services:
We have assembled an outstanding group of experts in program
design and management, epidemiology, statistics, health economics,
technology, integrated services, and related regulatory (safety,
coverage, privacy) aspects of registries, peri, and post-approval
programs. This team assists you with all aspects of your study:
Determining what type of program is the best choice to reach
your goals
Working with the initial planning group to explore purpose,
objectives, and feasibility
Developing your protocol and incorporating our knowledge of
real-world, practical, clinical research success factors
Establishing a governing structure to address key questions
that arise from the design through dissemination of results
Recruiting and managing sites in a manner which maximizes site
and patient acquisition and retention
Providing the central program coordination function that
focuses on clean data and quality assurance and manages the
day-to-day issues from implementation through analysis
Providing analysis and reporting, including facilitating and/or
creating publications and presentations at scientific
meetings
Support:
Outcome's focus on the customer extends into every aspect of
your program. Our focus on customer service begins with viewing
ourselves as your strategic partner, designing the best possible
program, and integrating the right technologies. It continues with
being responsive to your needs, recommending solutions, and
managing change. And, it exceeds your expectations by providing
site management (help desk) support often described as
best-in-class.
Outcome's research solutions integrate specialized
technology into every phase of a study. We believe that technology
plays a critical role in a successful registry or post-approval
program and building the solution around the most appropriate
technologies improves efficiency, ROI, and site satisfaction, and
decreases the time to results. Our patented and patent-pending technologies are unique because they are specifically designed for evaluating real-world
outcomes.
Feature-Rich Platform
Flexible input options: web, IVRS, PDA, fax, EMR, and Outcome
OfflineTM
Full uploads of existing data
Community communication tools
Team workspaces
Patient management tools
Integrated analytics for sites and sponsors
Compliant with FDA, EMEA, and HIPAA regulations
Customizable fields and forms
Real-time reports and benchmarking
Sponsor Data Analysis Tool (Outcome DATTM)
Automated safety notification system
And more!
Renee Hurleywww.outcome.com View Map Contact Company
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