Outcome is the market leader in patient registries, peri- and post-approval studies, 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 patient registries including many of the largest and most well-recognized programs for disease outcomes, safety, and risk management. Our programs span the globe, with thousands of sites across North America, Europe, Asia, South America, Africa, and Australia.

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 2,000 healthcare organizations are our direct customers.

We are also actively involved in supporting federal initiatives in regulating and promoting post-approval research. Outcome is an AHRQ DEcIDE Research Center, one of 13 research centers selected to conduct accelerated practice studies about the outcomes, comparative clinical effectiveness, safety, and appropriateness of healthcare items and services, as a component of AHRQ's Effective Health Care initiative.

Through Outcome's role as a DEcIDE Center, the company was awarded the task order "Registries for Evaluating Patient Outcomes," a project which led Outcome's Drs Richard Gliklich and Nancy Dreyer as the principal investigators and senior editors to develop the landmark federal handbook "Registries for Evaluating Patient Outcomes: A User's Guide," released in May 2007.

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

Our areas of focus include:

• Products (Drug or Medical Device)
• Healthcare Services (Including Procedures)
• Diseases or Conditions
• Exposure

IaD?Ÿ;Ÿ; Center, the company was awarded the task order "Registries for Evaluating Patient Outcomes," a project which led Outcome's Drs Richard Gliklich and Nancy Dreyer as the principal investigators and senior editors to develop the landmark federal handbook "Registries for Evaluating Patient Outcomes: A User's Guide," released in May 2007.

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 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 Offline%99
• 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 DAT%99)
• Automated safety notification system

Contact Information

Outcome
Renee Holmes, Marketing Manager
201 Broadway, 5th Floor
Cambridge, MA 02139 USA
Phone: 617-621-1600
Fax: 617-621-1620
E-mail:

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