News

The catalog of theranostic markers (TMs), which consists of biomarkers that help to identify patient populations best poised to respond favorably to a specific therapy, continues to expand.

WIRB-Copernicus Group® (WCG), a provider of regulatory and ethical review services and software to support clinical research, announced its 13th annual WCG International Fellows Program in Research Ethics now includes ethics training at New York University (NYU) Langone Medical Center.

 Changes in biopharmaceutical R&D strategies and Technological innovations in clinical research are challenging payers on evaluating novel therapeutics and their involvement in the R&D process.  While at the 2015 New York BIO annual convention, I had the opportunity to interview Nathan Tinker, Executive Director at the New York Biotechnology Association about how these changes are impacting payers. 

Bracket Global, and Clintara announced the two companies have agreed to combine.

The Society for Clinical Research Sites (SCRS) announced a two-year partnership with LabCorp.

The Tufts Center for the Study of Drug Development (CSDD) released a new report highlighting innovative approaches across the R&D continuum that pharmaceutical companies are implementing to drive efficiency and lower cost.

BBK Worldwide announced the availability of RSG® Arrive, a full-service concierge program created to more fully support clinical trial patients

The Association for the Accreditation of Human Research Protection Programs (AAHRPP) announced that it has accredited seven more organizations. Three of the newly accredited organizations are in Asia.

The EU has announced a new regulation - number 536/2014 - for clinical trials, which is planned to come into force not before 28th May 2016. It is an important step because it sets out the requirements for a single clinical trial approval portal and the content of clinical trial applications to be standardized.

Ostroff noted FDA’s expanded international presence, as seen in its expanding overseas offices and in continued efforts to combat infectious disease around the world.

Conversely, social media discussions about study requirements and procedures may discourage participation and undermine study integrity, according to experts at last week’s Drug Information Association (DIA) annual meeting in Washington, D.C.

Oracle Health Sciences announced the availability of Oracle Health Sciences InForm Cloud Service 6.1.

Catalent Singapore facility is awarded GMP certification.