
Friends of Cancer Research is urging Congress to encourage FDA to adopt a new “disease-oriented” approach biomedical regulation, and for FDA to formulate a pilot to test this approach.

Friends of Cancer Research is urging Congress to encourage FDA to adopt a new “disease-oriented” approach biomedical regulation, and for FDA to formulate a pilot to test this approach.


The late phase respiratory and cardiac safety study will involve 14,000 patients across 750 sites, the company's largest such trial in its history.



INC Research becomes the Society for Clinical Research Sites' inaugural "Circle of Innovation" sponsor, with a focus on enhancing site support globally.

The Center for Information and Study on Clinical Research Participation is launching its first international event, where in Europe, CISCRP says, patient involvement in clinical trials is waning and general awareness about research opportunities is low.

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.