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<h1>Registries </h1>
<p>ABS supports our sponsors with an expertise developed from two decades of designing, implementing, and managing successful registries and prospective observational studies on a global scale in a variety of therapeutic areas. Given the scope of our research services, our registry capabilities integrate the experience and insights of two different, but complementary, research traditions which are a part of our Abt Associates’ heritage — those of controlled clinical trials and applied social science field research. This diverse expertise allows us to draw on decades of peer-reviewed research methods to develop registry designs that withstand regulatory and peer scrutiny. We provide sponsors with an integrated approach to registry design, management, and operations that delivers "turnkey" research and analytic services that are cost-effective, coordinated, and feature a single point of contact.</p>
<p>Registries can be powerful, multifaceted tools when their design incorporates targeted scientific and commercial objectives that can be integrated into a single study because of their complementary nature. Registries, when designed effectively, provide a steady stream of valuable new information for physicians and other health care providers, to insurers and other private and public payers, and to regulatory authorities.</p>
<h2>Registries can be used to:</h2>
<ul>
<li>Assess treatment utilization patterns and patient outcomes in clinical settings </li>
<li>Identify drivers of prescribing behavior and persistence with therapy </li>
<li>Provide real-world data on safety and cost-effectiveness </li>
<li>Inform product positioning strategies and build market awareness of unmet needs </li>
<li>Support coverage and reimbursement strategies </li>
<li>Support adoption on the part of managed care organizations and health care practitioners in the community</li>
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<p>Registries offer value both at the pre-approval stage, in assessing baseline clinical practice patterns and optimizing the initial approach to market, and at the post-approval stage, where marketing strategies must be continually adjusted as the marketplace evolves to accommodate therapies as they enter (or leave) clinical practice, and the regulatory environmental changes.</p>
<h2>ABS’ specific capabilities that are crucial to registry success include: </h2>
<ul>
<li>We offer extensive experience in designing and implementing prospective observational studies of all sizes, and through experience have gained the ability to recognize and successfully address the many conceptual and operational challenges posed by such projects. </li>
<li>We understand how and why registries are different from clinical trials, and how to use the building blocks of registry design to construct registry plans specifically tailored to address our sponsors’ clinical and business objectives. </li>
<li>We have proven knowledge and experience in most therapeutic areas, including cardiovascular medicine, endocrinology and metabolic disorders, oncology, and infectious disease among many others. </li>
<li>Our registries team includes senior professional staff who combine backgrounds in clinical research and practice with years of experience in public policy and social research.</li>
<li> Our project leaders have the qualifications and experience to interact as peers with clinical professionals in both academic and community settings, and to create and manage advisory panels, steering committees, and other vehicles designed to facilitate achievement of our sponsors’ goals. </li>
<li>We are leaders in health care outcomes research and health economics, offering leading-edge capabilities in selection and, where necessary, design or validation of instruments to measure clinical, economic and quality of life impacts of therapeutic interventions. </li>
<li>We understand the strengths and limitations of data from observational studies and of the statistical methods that may be applied to such data, and are experienced in producing innovative data analyses and reports that meet the highest standards of professional peer review. </li>
<li>We have extensive logistical and study management capabilities tailored to the needs of clinical studies. </li>
<li>We have experience in designing and managing traditional (paper-based) and electronic (web-based, telephone-based, and other information technology-enriched modalities) data collection methods, and a critical appreciation of their respective costs, benefits, strengths and limitations. </li>
<li>We have demonstrated longstanding ability to achieve integrated scientific, clinical and marketing objectives in prospective registry studies. </li>
<li>We offer a distinguished record in the design and implementation of effective communication and messaging plans encompassing presentations, reports, and electronic and traditional publications targeted at a wide range of audiences internal and external to our sponsors. </li>
<li>We offer and integrated approach that enables a sponsor to obtain from a single source, in a cost-effective, coordinated manner, all of the services required to design and implement a successful observational study from start to finish. </li>
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