|By Business Wire||
|February 7, 2013 04:00 AM EST||
Aptiv Solutions, a biopharmaceutical and medical device development services company, and the leader in adaptive clinical trial design, simulation and execution, announces the completion of a key milestone in the development of a new platform for phase Ib and II adaptive design clinical trials.
Both regulatory agencies and the pharmaceutical industry agree that poor understanding of dose response is a major cause of late phase product attrition, and recognize that they need to improve critical decision-making in early stage clinical development so that appropriate doses are progressed to pivotal studies.
Aptiv Solutions has now completed the first phase of development of ADDPLAN® DF for dose finding trials and has successfully delivered this software platform to a major pharma company. ADDPLAN® DF is based on MCPmod methodology and covers model-based dose-finding designs for proof-of-concept testing and estimation of target doses in phase II clinical trials. MCPmod methodology is a preferred tool for dose-finding studies although until now fully validated design and analysis software has not been available. ADDPLAN® DF will allow researchers to establish a dose response signal based on a set of candidate models while strongly controlling the type I error, an important step in maintaining trial validity.
ADDPLAN® DF is linked to AptivAdvantage™, the proprietary Aptiv Solutions technology for implementation of adaptive trials, delivering the first integrated design and execution platform for exploratory trials to the market. This will enable the design and execution of proof-of-concept and phase II trials that more accurately determine the effective dose to take forward to phase III studies, leading to increased success in pivotal trials at the same time as improving the efficiency of the product development process.
“Fixing the dose selection problem in phase II is a crucial step in increasing the approval rate of novel treatments,” said Professor Andy Grieve, senior vice president clinical trial methodology, at Aptiv Solutions. “ADDPLAN® DF coupled with AptivAdvantageTM provides a key technology to address this issue.”
Pat Donnelly, chairman and chief executive officer of Aptiv Solutions commented “We are very excited about the benefits that an integrated design and execution platform for exploratory phase adaptive trials will bring to our clients.”
About ADDPLAN® and AptivAdvantageTM
ADDPLAN® is the leading fully validated design software for adaptive clinical trials and is in use at both US and European regulatory agencies. Four products are currently available for confirmatory trials: ADDPLAN® Base, ADDPLAN® MC (Multiple Comparisons), ADDPLAN® PE (Population Enrichment) and ADDPLAN® DF (Dose Finding).
AptivAdvantageTM is the only integrated technology platform specifically designed for adaptive clinical trials and comprises electronic data capture, randomization and drug supply management.
About Aptiv Solutions
Aptiv Solutions is a global development services company focused on enhancing clinical trial decision-making, efficiency and productivity in the pharmaceutical, biotech and medical device markets. The company offers clients an extensive portfolio of innovative services including adaptive clinical trials, translational research services, regulatory services, pharmacovigilance, clinical staffing and the operational support of a global clinical research organization. Aptiv Solutions has over 850 professionals in North America, Eastern & Western Europe, Israel, and Japan. Visit the website at www.aptivsolutions.com.
MongoDB Atlas leverages VPC peering for AWS, a service that allows multiple VPC networks to interact. This includes VPCs that belong to other AWS account holders. By performing cross account VPC peering, users ensure networks that host and communicate their data are secure. In his session at 20th Cloud Expo, Jay Gordon, a Developer Advocate at MongoDB, will explain how to properly architect your VPC using existing AWS tools and then peer with your MongoDB Atlas cluster. He'll discuss the secur...
Mar. 28, 2017 04:45 PM EDT Reads: 363
SYS-CON Events announced today that Linux Academy, the foremost online Linux and cloud training platform and community, will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Linux Academy was founded on the belief that providing high-quality, in-depth training should be available at an affordable price. Industry leaders in quality training, provided services, and student certification passes, its goal is to c...
Mar. 28, 2017 03:45 PM EDT Reads: 4,088
DevOps is often described as a combination of technology and culture. Without both, DevOps isn't complete. However, applying the culture to outdated technology is a recipe for disaster; as response times grow and connections between teams are delayed by technology, the culture will die. A Nutanix Enterprise Cloud has many benefits that provide the needed base for a true DevOps paradigm. In his Day 3 Keynote at 20th Cloud Expo, Chris Brown, a Solutions Marketing Manager at Nutanix, will explore t...
Mar. 28, 2017 03:45 PM EDT Reads: 3,066
In his session at Cloud Expo, Alan Winters, an entertainment executive/TV producer turned serial entrepreneur, will present a success story of an entrepreneur who has both suffered through and benefited from offshore development across multiple businesses: The smart choice, or how to select the right offshore development partner Warning signs, or how to minimize chances of making the wrong choice Collaboration, or how to establish the most effective work processes Budget control, or how to m...
Mar. 28, 2017 03:45 PM EDT Reads: 329
Deep learning has been very successful in social sciences and specially areas where there is a lot of data. Trading is another field that can be viewed as social science with a lot of data. With the advent of Deep Learning and Big Data technologies for efficient computation, we are finally able to use the same methods in investment management as we would in face recognition or in making chat-bots. In his session at 20th Cloud Expo, Gaurav Chakravorty, co-founder and Head of Strategy Development ...
Mar. 28, 2017 03:45 PM EDT Reads: 3,755
"delaPlex is a software development company. We do team-based outsourcing development," explained Mark Rivers, COO and Co-founder of delaPlex Software, in this SYS-CON.tv interview at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York City, NY.
Mar. 28, 2017 03:00 PM EDT Reads: 9,601
SYS-CON Events announced today that SoftLayer, an IBM Company, has been named “Gold Sponsor” of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2016, at the Javits Center in New York, New York. SoftLayer, an IBM Company, provides cloud infrastructure as a service from a growing number of data centers and network points of presence around the world. SoftLayer’s customers range from Web startups to global enterprises.
Mar. 28, 2017 03:00 PM EDT Reads: 2,078
SYS-CON Events announced today that Technologic Systems Inc., an embedded systems solutions company, will exhibit at SYS-CON's @ThingsExpo, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Technologic Systems is an embedded systems company with headquarters in Fountain Hills, Arizona. They have been in business for 32 years, helping more than 8,000 OEM customers and building over a hundred COTS products that have never been discontinued. Technologic Systems’ pr...
Mar. 28, 2017 02:15 PM EDT Reads: 3,639
SYS-CON Events announced today that CA Technologies has been named “Platinum Sponsor” of SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY, and the 21st International Cloud Expo®, which will take place October 31-November 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. CA Technologies helps customers succeed in a future where every business – from apparel to energy – is being rewritten by software. From ...
Mar. 28, 2017 02:15 PM EDT Reads: 2,170
In his keynote at @ThingsExpo, Chris Matthieu, Director of IoT Engineering at Citrix and co-founder and CTO of Octoblu, focused on building an IoT platform and company. He provided a behind-the-scenes look at Octoblu’s platform, business, and pivots along the way (including the Citrix acquisition of Octoblu).
Mar. 28, 2017 02:00 PM EDT Reads: 14,240
SYS-CON Events announced today that Auditwerx will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Auditwerx specializes in SOC 1, SOC 2, and SOC 3 attestation services throughout the U.S. and Canada. As a division of Carr, Riggs & Ingram (CRI), one of the top 20 largest CPA firms nationally, you can expect the resources, skills, and experience of a much larger firm combined with the accessibility and atten...
Mar. 28, 2017 01:31 PM EDT Reads: 278
What if you could build a web application that could support true web-scale traffic without having to ever provision or manage a single server? Sounds magical, and it is! In his session at 20th Cloud Expo, Chris Munns, Senior Developer Advocate for Serverless Applications at Amazon Web Services, will show how to build a serverless website that scales automatically using services like AWS Lambda, Amazon API Gateway, and Amazon S3. We will review several frameworks that can help you build serverle...
Mar. 28, 2017 01:15 PM EDT Reads: 2,189
SYS-CON Events announced today that Loom Systems will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Founded in 2015, Loom Systems delivers an advanced AI solution to predict and prevent problems in the digital business. Loom stands alone in the industry as an AI analysis platform requiring no prior math knowledge from operators, leveraging the existing staff to succeed in the digital era. With offices in S...
Mar. 28, 2017 01:15 PM EDT Reads: 1,611
SYS-CON Events announced today that HTBase will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. HTBase (Gartner 2016 Cool Vendor) delivers a Composable IT infrastructure solution architected for agility and increased efficiency. It turns compute, storage, and fabric into fluid pools of resources that are easily composed and re-composed to meet each application’s needs. With HTBase, companies can quickly prov...
Mar. 28, 2017 12:45 PM EDT Reads: 3,126
SYS-CON Events announced today that Cloud Academy will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Cloud Academy is the industry’s most innovative, vendor-neutral cloud technology training platform. Cloud Academy provides continuous learning solutions for individuals and enterprise teams for Amazon Web Services, Microsoft Azure, Google Cloud Platform, and the most popular cloud computing technologies. Ge...
Mar. 28, 2017 11:30 AM EDT Reads: 4,688