News

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.

Medidata announced the completion of MOVE-2014, a behavioral study it sponsored to test whether mobile health (mHealth) devices and tools could be used to drive better health outcomes in overweight adults with Type-2 Diabetes.

Quintiles is extending its award-winning Quintiles Infosario® technology platform with mobile access to clinical trial information.

At the invitation of the FDA, Nextrials recently demonstrated to members how the integration capabilities of its Prism® clinical data and trial management platform could improve data collection and drug safety reporting.

OmniComm Systems, a global provider of clinical data management technology, announced its Promasys® EDC was selected by Integrated Development Associates.

PHILADELPHIA, June 15, 2015 /PRNewswire/ -- Today, as thousands of drug makers interact at the 2015 BIO International Convention, Deloitte is releasing a report suggesting that biopharmaceutical companies could have greater success if they collaborate with other organizations – even competitors – as part of an open innovation approach to research and development.

The report presents a construct of four levels of open innovation.

PPD and HealthCore, the clinical outcomes research subsidiary of Anthem, have established a collaboration that will enable both companies to further expand their services.