MORRISVILLE, N.C. (Business Wire) January 15, 2013 – Clinipace Worldwide, a global digital contract research organization (dCRO), today announced significant innovations to its proprietaryTEMPO™ eClinical platform. As a private cloud-based application, TEMPO serves as the technology foundation to all of Clinipace’s clinical development service delivery teams.
Through its one platform-one database approach, Clinipace and client study teams leverage TEMPO to improve study visibility, control deliverables and documents, and reduce costs from start-up to close-out. TEMPO replaces the need for multiple disparate technologies such as CTMS, EDC, TMF, Safety, and Portals, which are bolt-on applications that increase trial complexity, cost, and “friction” points between functional groups.
With this TEMPO release, Clinipace introduces the concept of Configurable Modules, which are a set of predefined workflows, forms, and reports bundled together as a unit on the same platform within one database. These flexible modules enable study teams to deploy the right set of functionality to support the unique needs of a single study and support more functions without the need for costly data duplication or systems integration.
Published modules include:
- TEMPO™ Monitoring & Trip Reports
- TEMPO™ Study Portal
- TEMPO™ Safety Management & Reporting
- TEMPO™ Trial Manager
- TEMPO™ Trial Master File (eTMF)
This most recent release of TEMPO also marks the first time the platform has been offered on a Shared Component Framework (SCF), which allows our clients to manage multiple trials supported by TEMPO. Leveraging the TEMPO data model, the SCF enables simplified, yet powerful, reporting and visibility across an unlimited portfolio of trials. This same approach provides Clinipace with the ability to better monitor and manage its entire portfolio of trials leading to better service and higher quality for our clients.
“The ability to provide cross-function and cross-trial management and visibility without excessive and expensive IT infrastructure is a huge benefit to our clients and a significant differentiator for the company,” said Daryl Porter, Chief Technology Officer, Clinipace Worldwide. “Through this new framework we can more rapidly deploy innovative services that enhance quality, while creating additional efficiencies that continuously improve study visibility without lengthy development cycles.”
“As an example, we’ve created new software tools and related methods called Just-In-Time Monitoring to enhance our team’s ability to perform more risk-based monitoring, which has the potential to dramatically change the way we interact with our investigator sites and perform monitoring activities. With Just-In-Time Monitoring, activities are driven by data and analytics derived from actual site enrollment and behavior, not a generic static plan that relies exclusively on the site visit. By combining this increased level of information and analysis with experienced project leadership and CRAs we’re able to deliver superior performance and quality,” Porter continues.
Additional TEMPO upgrades include:
- On-demand daily clinical exports (SAS, CSV, XML, MDB, PDF)
- Self-service PDF patient casebooks (patient profiles)
- New dashboard components and data visualization
- Drill2everywhere searchable reports
- Inline query processing
- Self-service audit trail reporting
- DICOM medical imaging
“As a digital CRO, Clinipace Worldwide is leading the way in pioneering clinical research where technology is the fuel that powers the services engine resulting in higher quality deliverables and smarter project teams.” said Jeff Williams, Clinipace Worldwide CEO. “TEMPO enables an unparalleled level of visibility into the activities of all project stakeholders, from sites to CRAs to lab vendors, which allows for proactive and informed decision-making. For our clients, total visibility promotes accountability, increases quality and reduces risk.”
For more information on Clinipace Worldwide’s TEMPO platform, visit http://www.clinipace.com/eclinical-software-tempo.
About Clinipace Worldwide
As a global full-service digital contract research organization (dCRO), we have pioneered an innovative technology-amplified CRO service model to serve the unique needs of venture-backed, mid-tier, and strategic pharmaceutical, biotechnology, and medical device firms. Powered by TEMPO™, our proprietary eClinical platform, our team of experts brings extensive therapeutic knowledge and insight into assisting life science firms in developing and executing regulatory strategies, clinical development, and post-approval research to ensure a successful drug and medical device development program. We have managed over 1,200 global clinical research, strategic product development, regulatory, and GxP/CMC/QA projects in therapeutic areas such as cardiovascular & metabolic diseases, central nervous system, dermatology, gastroenterology, immunology, infectious diseases, nephrology, oncology, respiratory, rheumatology, and vaccines (and other cell and tissue based therapies). Clinipace Worldwide is headquartered in Research Triangle Park, North Carolina with offices in Irvine (CA), Boulder (CO), Overland Park (KS), Zurich (CH), Munich (DE), High Wycombe (UK), Tel-Aviv (IL), Sao Paulo (BR), Buenos Aires (AR), Trivandrum Kerala (IN) and New Delhi (IN). For more information, visit our website at www.clinipace.com.