Topic:

Clinical IT

Latest Headlines

Latest Headlines

WHO calls for easy linking of bibliographic databases to trial registries

The World Health Organization has updated its position on the disclosure of clinical trial data. Having advocated greater use of registries back in 2005, WHO now wants to see the establishment of a more integrated IT system that includes data from new and old clinical trials.

Peking University inks Medidata deal as China inches into eClinical era

Peking University Clinical Research Institute is trying to drag China into the eClinical era by expanding its alliance with Medidata. Under the terms of the revised relationship, the partners will help local drug developers access electronic data capture tools and other eClinical technologies.

Celgene, Genentech back clinical trial enrollment challenge

Celgene and Genentech are funding a clinical trial innovation prize focused on doubling the rate of participation in studies of cancer drugs. The project is challenging the crowd to submit ideas and evidence of their effectiveness in return for the chance to land a piece of the $75,000 prize kitty.

AstraZeneca's rapid-fire IT dealmaking continues with Elixir hookup

AstraZeneca is extending its use of Elixir Software's R&D workflow-management software, in part to support communication while it is moving its focal point in the United Kingdom from Alderley Park to Cambridge.

Sanofi-backed virtual trial gets green light in Europe

A Sanofi-backed consortium has won clearance to run a virtual diabetes trial in Europe. The regulatory nod reportedly marks the first time European authorities have green-lit a clinical trial with full electronic informed consent.

FDA seeks budget boost for precision medicine IT infrastructure

The FDA has requested $2 million in President Obama's 2016 budget to build precision medicine-related IT infrastructure. The regulator highlighted cloud computing and data security as areas in which it needs to improve.

J&J, IOM provide big boosts to data transparency agenda

The clinical trial data transparency movement was propelled forward by two major developments this week. On the same day, influential national academy the Institute of Medicine called for more systematic sharing of trial results and Johnson & Johnson agreed to extend its transparency initiative to include medical devices and diagnostics.

Novartis picks Qualcomm tech to enable remote collection of trial data

Novartis has added another component to its "Clinical Trials of the Future" program. The latest element of the trial efficiency initiative sees the Swiss Big Pharma team up with computer chip maker Qualcomm to gather data on clinical trial participants between visits to the investigator site.

FDA to publish guidance on social media and clinical trial e-consent in 2015

The FDA has released a list of almost 100 draft drug guidance documents it plans to introduce or update in 2015. The documents cover a range of biotech IT-related topics, including electronic informed consent in clinical trials, links to third-party sites in social media adverts and statistical approaches to showing biosimilarity.

GSK, Medidata report on positive pilot of mHealth in clinical trials

GlaxoSmithKline and Medidata have moved mHealth tools one step closer to the clinical trial mainstream. Having run a pilot project, the partners have concluded that mHealth technologies can deliver reliable, FDA-compliant data and improve the clinical trial experience for patients.