Consulting for Adaptive Trials

We offer a range of services to help you achieve the best possible adaptive trial, including:

• Generation of the data sets required to demonstrate the value of an adaptive design trial over a conventional study
• Analysis and critique of the statistical approaches and execution challenges associated with Sponsor Company adaptive trials
• Provision of insight into new design methodologies and statistical approaches tailored to specific Sponsor trials
• Analysis and review of adaptive trial strategies across a portfolio of development products
• Provision of oversight for ongoing adaptive trials to ensure that trial integrity and validity are maintained at all times

For certain types of adaptive design trials it is advisable to meet and discuss the trial design with regulatory agencies. This is particularly true for confirmatory trials.

Aptiv Solutions has considerable experience in helping Sponsor companies discuss their adaptive designs with regulatory agencies including pre-IND and end-of-phase II meetings with the FDA and scientific advice and protocol assistance meetings with the European authorities (EMA and national agencies).

Our global regulatory team, in conjunction with our Innovation Center experts, will provide comprehensive support covering all the requirements for agency meetings including:

• Preparation of a simulation report and statistical analysis plan covering the adaptive design
• Data review and preparation of draft questions
• Preparation and submission of the formal meeting request
• Preparation of the briefing book including finalization of questions
• Management of meeting logistics and meeting rehearsal
• Attendance and representation at the meeting
• Authorship and review of meeting minutes

ICON is committed to the continual development of innovative trial methodology and software to support the design, simulation and execution of adaptive trials. Our experts are actively involved with the development of innovative statistical methodologies that serve to expand the repertoire of available adaptive designs. These methodologies are embedded into robust, fully-validated adaptive design software packages and made available to Sponsor companies.

Our specialized Software Development team, in conjunction with our Innovation Center experts, is actively involved with the refinement of technologies that support the conduct of adaptive trials including the further development ofADDPLAN.

Our goal is to help Sponsor Companies overcome the logistical and operational hurdles to adaptive trial execution through the creation of technology solutions that build robustness, integrity and efficiency into the product development process.