Applied Clinical Trials presents the latest issues that have risen to prominence since RBM adoption grows. This edition presents a well-rounded look at RBM including articles that describe current RBM trends; a survey of European CRAs, which shows the difficulties among sites and monitors with RBM; a comprehensive look at how sponsors and CROs can support their employees in the RBM transition, and closes with a case study on Novartis' use of adaptive monitoring.
The goal of the Catalyst program is to strengthen collaborations with clinical research sites worldwide through network and community approaches.
Research group finds that only 29% of completed clinical trials at major U.S. academic centers were published within two years of completion.
FDA intends to expand the use of Sentinel by leveraging its data for additional research, public health and quality improvement activities.
The team joined Parexel from GlaxoSmithKline’s Genetics and Computational Biology departments and expands capabilities in genomic-based drug development.
Two of the most important elements to the integrity of a controlled clinical trial are the patient randomization and the treatment blinding. With a focus on block pattern distribution, four methods of randomization list creation are analyzed.
A global biotech will be migrating to its newest generation Interactive Response Technology (IRT), platform for the upcoming build of 15 clinical studies across multiple therapeutic areas in early 2016.
F1RST Up offers an exclusive alliance of 200 physician investigators, in nephrology, and accelerates study startup by eliminating the administrative and contracting burdens.
The Professional Services Division, provides hands-on experience for managing and enhancing Interactive Response Technology (IRT) systems.
OmniComm’s TrialMaster EDC suite will be used for the collection of clinical data during a five year term in global Phase I to Phase III clinical studies.
PPD has expanded Preclarus, its clinical data platform, to enable study sites to access central lab data in real time, and improve inventory management and order tracking, among other features.
Celgene has expanded its eight-year technology relationship with Medidata to add the Medidata Clinical Cloud® as its enterprise technology platform.
Bayer HealthCare has selected Oracle Siebel Clinical Trial Management System and Oracle Health Sciences Clinical Development Analytics.
As data management partner, ICON will use its data management capabilities, and understanding of the growing role genomics data will have in clinical trials, to validate clinical data from the 70,000 participating patients and their families.
Reactive, hastily enforced regulations can easily jeopardize the sound conduct of a clinical trial and its data flow, potentially threatening both subject safety and data quality.
Using performance indicators in CRO/Vendor oversight ranges from the basic, to the unreliable to emerging innovations and strategies.
Through collaboration with leading technology providers, pharmaceutical researchers, and ERT scientists, the Lab is developing and testing diverse technologies for use in clinical research.