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June 03, 2015 3:41 AM ET

Life Sciences Tools and Services

Company Overview of Aptiv Solutions, Inc.

Company Overview

Aptiv Solutions, Inc. provides clinical trial decision-making services and drug and device development through the design, simulation, and execution of adaptive clinical trials. The company develops and delivers technologies and expert solutions for conducting global clinical trials to improve medicine and public health. It offers medical device clinical trials, such as strategy and study design, project management, clinical monitoring, medical monitoring, data management, clinical report preparation, biostatistics, SAS programming, audits preparation, clinical trial rescue, and medical device trials staffing services. The company also provides clinical trial management services, including p...

1925 Isaac Newton Square

Suite 100

Reston, VA 20190

United States

Founded in 1983

440 Employees

Phone:

703-483-6400

Fax:

703-435-4031

Key Executives for Aptiv Solutions, Inc.

Chairman and Chief Executive Officer
Age: 56
Chief Financial Officer
Chief Operating Officer and Executive Vice President
Age: 61
President of Trio Clinical Resourcing
Chief Medical Officer and Executive Vice President
Age: 65
Compensation as of Fiscal Year 2014.

Aptiv Solutions, Inc. Key Developments

Aptiv Solutions, Inc. Presents at EuroMedtech 2014, May-06-2014 through May-08-2014

Aptiv Solutions, Inc. Presents at EuroMedtech 2014, May-06-2014 through May-08-2014. Venue: Marriott Linz Hotel, Europaplatz 2, A-4020, Linz, Austria. Presentation Date & Speakers: May-07-2014, Bernard Sweeney, Senior Vice President of Medical Devices, Vicki Anastasi, Senior VP, Medical Devices.

Aptiv Solutions, Inc. Enhances its AptivInSite Risk-Based Monitoring

Aptiv Solutions, Inc. announced the integration of 'Verification by Statistical Sampling' into AptivInSite to improve data quality and more reliably deliver on the cost savings achievable through risk-based monitoring. AptivInSite is an umbrella methodology underpinning the Company's approach to risk-based quality management for drug, device, and diagnostic trials. The new approach embeds advanced statistical sampling to more efficiently manage the on-site monitoring process. Clinical on-site monitoring employing 100% source data verification (SDV) is one of the largest drivers of the costs of a clinical trial. Although alternative monitoring strategies that involve reduced SDV, including risk-based monitoring, have been proposed for several years, these strategies have not yet been widely adopted across industry. The primary reason for low adoption appears to be lack of clarity from regulatory authorities as to what constitutes sufficient and acceptable monitoring. Regulatory authorities have recently released specific guidance on the acceptability of alternative monitoring approaches. Applying this framework, Aptiv Solutions has developed AptivInSite, a novel approach to trial quality management that complies with the available regulatory guidance. Verification by Statistical Sampling (VSS) uses a proprietary statistical sampling algorithm, developed by Professor Andy Grieve, Senior Vice President, Clinical Trial Methodology at Aptiv Solutions. VSS provides the statistical justification to reduce the number of data points to be verified at each visit, resulting in fewer required monitoring visits and more time per visit to devote to improving data quality at the site beyond clerical transcription errors. This includes, for example, ensuring clinicians at the trial site are properly trained and faithfully following the trial protocol.

Aptiv Solutions Launches ADDPLAN(R) DF for Optimizing Dose Selection in Phase 2 Trials

Aptiv Solutions announced the release of ADDPLAN(R) DF, innovative software that designs, simulates, and analyzes Phase 2 dose finding studies to make them more efficient and effective. ADDPLAN(R) DF is the latest product in the ADDPLAN(R) family that includes a series of products for adaptive confirmatory trials. ADDPLAN(R) DF is a fully-validated design and analysis tool based on MCP-Mod methodology (a combination of Multiple Comparison Procedures and Modeling) and covers dose finding designs for establishing Proof of Concept and determining the optimum target dose to select for Phase 3 trials. This tool will enable drug developers to remove a number of the uncertainties inherent in Phase 2 dose finding trials and improve critical decisions on dose-selection, which will directly impact the probability of success in Phase 3. Currently half of Phase 3 trials fail, in part because of poor dose selection in Phase 2. Regulators, pharmaceutical companies and industry groups recognize that more robust Phase 2 studies are required to improve dose selection and this is the stimulus driving the development of ADDPLAN(R) DF. The benefits of ADDPLAN(R) DF are applicable to mid-size and large pharmaceutical companies taking novel products through Phase 3, as well as biotech companies looking to increase the value of their early stage assets and to partner at Phase 2. A further application is in medical device development where different strengths of a specific stimulus need to be evaluated. This release of ADDPLAN(R) DF is the first in a series of novel methodologies for use in Phase 2 clinical trials. Subsequent versions will be released that deliver additional benefits to this critical phase of exploratory development.

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