Icon expands its capabilities as a clinical research organization through the acquisition of Aptiv Solutions, bringing adaptive clinical trial and risk-based monitoring capabilities.
On 31 March 2014, the clinical research organization (CRO) Icon announced it acquired privately held Aptiv Solutions for $143.5 million. Aptiv provides adaptive clinical trial contract services and software.
This acquisition will enable Icon clients to use more effective adaptive clinical trial services and additional tools for risk-based monitoring. Aptiv developed Addplan statistical sampling software for risk-based monitoring, used by the FDA and regulators in Europe and Japan. It strengthens Icon’s clinical informatics suite and the value proposition for clients looking for risk-based monitoring capabilities.
Icon customers will gain access to a services unit with deep management experience of medical device trials and regulatory expertise to expedite development of a range of medical devices. They will also gain access to Aptiv’s involvement with major drug companies, developing statistical methodologies for dose-finding clinical trials, with an emphasis on adaptive designs. Icon customers will soon be able to:
Use Aptiv’s Addplan DF software and expertise to design better dose-finding trials.
Use Aptiv’s tools for capturing surrogate endpoints, which include biomarkers that substitute for clinical endpoints and expedite interim analysis of trials. (Drugs that show clinical benefit on certain types of surrogate endpoints can receive a breakthrough therapy designation from the FDA that expedites development and review.) Phase 2 and Phase 3 seamless trials offer one particular area for application.
Use Addplan to more effectively simulate and plan adaptive trials, and execute adaptive clinical trials through AptivAdvantage, an integrated technology platform designed for running sophisticated adaptive trials, particularly those in exploratory development.
Expand adaptive clinical trials with local language and support capabilities into all territories covered by the combined organization.
Gartner expects Icon and Aptiv to spend the next 12 months integrating, and organizing new sales and delivery teams, which could have intermediate impacts on the level of service and support. The core Addplan software will likely not be integrated into Iconik suite via a major revision for at least another 18 months. However, customers should expect near-term minor integration and branding activities.
Reaffirm ongoing and scheduled maintenance work, systems support and upgrade schedules to Addplan software. Accelerate current negotiations on follow-up efforts to avoid potential changes to terms and conditions.
Complete negotiations of new license agreements or maintenance renewals.
Consider the broader Icon capabilities for running end-to-end clinical trials.
Consider services and software for adaptive trials, but allow time for the business, process and software integration. Eventually major portions of the AptivAdvantage platform for running adaptive clinical trials should be integrated into the Iconik environment.