The Regulatory Affairs Professionals Society (RAPS) will be holding a virtual seminar on adaptive clinical trials June 18, 2013. The half-day event, which will take place online, is scheduled to last from noon EDT until 5 p.m. A number of adaptive trial design experts will be present at the event, which is titled “Understanding Regulatory … continue reading
Join us on June 18, 2013 when Aptiv Solutions, industry experts, and the FDA will participate in the RAPS Virtual Workshop, “Understanding the Regulatory Landscape for Adaptive Design Trials.” Adaptive design trials are gaining wider acceptance across the drug, medical device, and diagnostics industries and have the potential to increase development efficiency, productivity, and the … continue reading
Adaptive clinical trials can dramatically improve clinical trial efficiency and productivity, and are rapidly gaining traction in our industry. They have strong regulatory and ethical backing, save significant amounts of money, improve critical decision-making, and can reduce late-phase attrition. Join industry experts from Roche, Novartis, Boehringer-Ingelheim, and others in a complimentary half-day seminar to discuss … continue reading
Join Aptiv Solutions for a corporate showcase presentation and cocktail reception at the 32nd American Pain Society Scientific Meeting taking place May 8-11th in New Orleans, LA, and learn why adaptive design is critical to your drug development program. Selecting the right dose to take forward to phase III trials is a critical step in … continue reading
Mobile health is here to stay, and for many medical device companies it will drive future business success. Join us on April 16 for this complimentary seminar to hear from a panel of global experts on “The What, The How and The Why of M2M Communication in Medical Devices.” This half-day event features a variety … continue reading
On January 22, Vlad Dragalin, SVP, Clinical Trial Innovation Strategies at Aptiv Solutions, will present a webinar on Adaptive Population Enrichment Designs, offered by the American Statistical Association’s Biopharmaceutical Section web-based training program. Recent breakthroughs in identifying clinically actionable biomarkers allow a paradigm shift in clinical trial design and a focus on patient subpopulations with … continue reading
The medical device industry is up in arms about the medical device tax that was included as part of the Affordable Care Act, a piece of legislation that looks like it will proceed unchallenged given the recent electoral victory of its primary champion, President Barack Obama. The measure, which will go into effect January 1, … continue reading
MDUFA, first enacted in 2003, is the legislation that allows the FDA to collect user fees from medical device manufacturers as part of the product submission and review process. This year, the legislation was reauthorized for the third time following successful negotiations between the Agency and industry. Aptiv Solutions, in collaboration with CHI-California Healthcare Institute … continue reading
Join us for a free webinar, offered on September 18 and September 19 at 10 a.m. BST. The one-hour program will provide outsourcing managers and procurement professionals with a clear understanding of the importance of adaptive design trials for both patients and industry. Learn how adaptive design trials can improve R&D efficiency and productivity, with … continue reading
Aptiv Solutions will be sending Judith Quinlan, Senior Vice President, Adaptive Trial Design & Implementation, Innovations Center, to the upcoming Disruptive Innovations to Advance Clinical Trials conference in Boston, MA. This conference, which runs from September 13 to September 14, is focused on highlighting the work and ideas of individuals in the drug development community … continue reading
