Life Sciences Tools and Services
Company Overview of Aptiv Solutions, Inc.
Aptiv Solutions, Inc. was acquired by ICON Public Limited Company. 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 co...
1925 Isaac Newton Square
Reston, VA 20190
Founded in 1983
Key Executives for Aptiv Solutions, Inc.
Aptiv Solutions, Inc. does not have any Key Executives recorded.
Aptiv Solutions, Inc. Key Developments
Aptiv Solutions, Inc. Presents at EuroMedtech 2014, May-06-2014 through May-08-2014
Mar 20 14
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
Nov 5 13
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.
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