Aptiv Solutions, LLC

Description

Aptiv Solutions . Aptiv Solutions is a recognised leader in the design and execution of adaptive clinical trials for pharmaceutical and biotech customers. The company also has in-depth experience in the management of medical device trials and its Japanese subsidiary, Niphix, is a full-service, oncology-focused CRO serving both Japanese and international customers. “Aptiv’s adaptive trial capabilities, combined with our existing technology platforms, such as ICONIK and Firecrest, will further differentiate our services and help our customers take time and cost out of the development process,” commented Dr.

Send us your raw or derived data sets and we can convert them applying the most rigorous CDISC standards. Whether you have new data or a legacy database, we can transform your data to meet the most exacting of standards – CDISC – providing you with the highest quality TLF in the most FDA-friendly formats. (CDISC stands for Clinical Data Interchange Standards Consortium and represents the highest industry standard for clinical data formatting, data derivation, data presentation.) Why choose Aptiv Solutions for your programming needs? Highly skilled, efficient programmers create accurate and well planned programming upfront, minimizing the need for downstream fixes. Highest quality programming with robust quality control processes under our own ISO quality system – Aptiv Solutions understands all industry best practices, regulations, and standards. Responsive team approach – you can communicate directly with the people working on your project. Agile and available, with short turnaround times – we work to meet your deadlines.

AptivExpress is an easy to use, fully integrated software suite specifically designed to be cost effective for most medical device trials. It is a validated, CRF 21 Part 11 compliant system that includes electronic data capture (EDC), electronic patient reported outcomes (ePRO), randomization, dictionary coding, live reporting, and more. Features Faster study build and deployment Lower costs Data ownership Greater flexibility Easier use for investigators and sites Regulatory compliance Benefits Simple yet powerful configuration tools allow us to develop and configure your unique study design. Using automated and customizable templates, your study can go live in as quickly as a few days or weeks. Save time and money by eliminating the need for complex programming and additional IT infrastructure. Maintain complete control of your data. Real-time, on-demand, standard and custom reports, and a configurable data export tool, give you the power to easily interact with your data. Manage an EDC, paper or hybrid study all within the same study design.

ADDPLAN ® DF Consortium Founded in 2013, the ADDPLAN DF Consortium is comprised of Novartis Pharma AG, Janssen Pharmaceuticals Inc., Eli Lilly, and Aptiv Solutions. The consortium’s objective is to deliver a comprehensive platform and process map for the integrated design and execution of innovative exploratory phase adaptive trials. Currently half of Phase III trials fail, in part because of poor dose selection in Phase II. Many designs focus on too few and too narrow a range of doses, often forcing sponsors to repeat studies to find the minimum effective dose, resulting in increased overall cost, duration, and unnecessary patient risk. Also, the most common statistical methods for estimating target dose are prone to uncertainty, which can result in the use of an inappropriate statistical model that over- or under-estimates the true effective dose.

About Aptiv Solutions Aptiv Solutions, an ICON plc company, is a global development services company, focused on enhancing clinical trial decision-making and drug and device development through the design, simulation and execution of adaptive clinical trials and a novel statistical sampling approach to risk?based monitoring.

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