Aptuit has updated its supply application to include new labeling functionality. Aptuit had previously acquired the integrated labeling solution called Clinicopia Suite. By implementing the labeling component of Clinicopia within Aptuit’s Clinical Packaging and Logistics facilities, Aptuit has achieved the first milestone in a multi-phase rollout of the entire Clinicopia Suite across all of its facilities worldwide. Eventually, the Clinicopia Suite will work as the “information spine” of Aptuit, offering clients increased transparency and real-time data access for all projects.
Clinicopia Labeling is a clinical label creation and management system. It allows the integration of random data, as well as thermal and laser printing. It includes a Java-based graphics editor and a global electronic web-approval routing system. Clinicopia Labeling provides the complete functionality needed to develop artwork for labels used on all packages associated with a clinical study and is currently being used by many top-tier pharmaceutical companies, the company reports.
“We have taken the first step in the global roll out of a comprehensive drug management system, ultimately creating the industry’s first seamless IT system that enables complete client-accessible project management and test data,” said Scott Houlton, president of clinical operations at Aptuit.
For now, Aptuit plans to utilize the technology internally to increase the speed and efficiency of clinical packaging and logistics. Ultimately, Aptuit will roll out the system to clients so they will be able to directly access the application’s functionality to monitor their projects from anywhere, in real-time. Clients will be able to utilize features, such as an electronic routing system and web approval, a pre-approved phrase library, and two-way genealogy, without having to license the product or navigate through an extensive validation and implementation process.
“As one of the first steps in our mission to engineer a better drug development process, we are streamlining our internal infrastructure and practices. The completion of this initial phase will allow us to provide our clients with a world-class turnkey solution for their labeling outsourcing needs,” said Michael A. Griffith, CEO of Aptuit. “Clinicopia is an industrially-robust solution and, once fully installed, will play an important role in the realization of the industry’s first end-to-end IT solution for the entire drug development continuum.”
Aptuit has made a significant investment toward institutionalizing the Clinicopia Solution offering by qualifying the software so that users can implement it without the need for operation qualification (OQ) tests. Clients can use the software in their IT environment with just a performance qualification (PQ), significantly reducing the cost and effort to either deploy or upgrade to a newer version. The 4.1 Straight-to-PQ version is expected to be available to clients in the first quarter of 2007.
Aptuit is focused on streamlining and supporting the drug development process. Currently, the company has more than 2,000 employees, 12 global facilities, and resources to reach 70 countries. The Aptuit Informatics unit develops, implements, and maintains enterprise-class, mission-critical information systems for the drug development market. Its clients include: AstraZeneca, Abbott Laboratories, Chiron, Organon, Procter & Gamble and Pfizer.d9A2t49mkex