Regulatory affairs

SCOPE 2019

Sites challenged with fragmented processes that ‘drain resources’

21-Feb-2019 By Maggie Lynch

Clinical trial sites are challenged by fragmented financial processes, according to a new study by the Society of Clinical Research sites and Greenphire released this week at SCOPE 2019.

PPD signs exclusive agreement with China-based AI company

21-Feb-2019 By Melissa Fassbender

PPD’s agreement with China-based Happy Life Tech focuses on site selection, patient recruitment, and real-world evidence generation for customers globally.

AI threatens health data privacy: Report

19-Feb-2019 By Melissa Fassbender

Artificial intelligence advances threaten data privacy, according to a new study, which found it is possible to re-identify individuals using their physical activity data.

SCOPE 2019

Oracle integrates Quorum IRB tech to smooth submission process

19-Feb-2019 By Melissa Fassbender

The collaboration between Quorum Review IRB and Oracle goBalto removes the need to send IRB submission documents manually.

SCOPE 2019

Shimmer shines with a new wearable platform for clinical trials

19-Feb-2019 By Melissa Fassbender

Shimmer designed its new Verisense platform from the ground up after finding that current activity trackers fail to meet the “basic needs of the clinical research market,” says company executive.

EMA implored to improve trial reporting, with over 50% of trials still missing results

18-Feb-2019 By Melissa Fassbender

The EMA needs to fix problems with the clinical trial registry to improve reporting across Europe, says TranspariMED founder, as seemingly small issues can “seriously hinder compliance.”

SCOPE 2019

Tech is advancing, but uncertainty creates an ‘opposing effect’ to positive movement

18-Feb-2019 By Melissa Fassbender

The industry has advanced to a point that should justify the financial investment in new technology, though uncertainty, and a lack of support, are hindering movement.

Lonza utilizes global network for CBD-based drug manufacture

18-Feb-2019 By Maggie Lynch

Lonza and Emerald Health enter an agreement for the large-scale manufacturing of a synthetic derivative of CBD and its oral drug product for the treatment of MS and other CNS diseases.

‘Couldn’t do it without technology’: Embracing clinical software for trial recruitment

15-Feb-2019 By Maggie Lynch

Getting patients into possibly life-saving trials has long been a complex process, however, with the age of electronic health records and cloud-based data, there are opportunities for simplification.

Icon introduces new drug safety reporting solution

11-Feb-2019 By Melissa Fassbender

Icon’s new drug safety reporting platform automates complex processes to ensure compliance in the ‘ever-changing’ regulatory environment, says VP.

PE firm's £459m capital fund invests in growing CRO

07-Feb-2019 By Maggie Lynch

The UK-based private equity firm CBPE has purchased a majority stake in Simbec-Orion and will expand the CRO's reach both geographically and across all business units.

TrialAssure discounts pricing for academics: ‘It is crucial for universities to get it right’

04-Feb-2019 By Melissa Fassbender

The global software provider is discounting its reporting software for academics, as universities globally struggle with compliance and face increasing pressure to publish clinical trial results.

Wasdell gets HPRA nod at its new EU headquarters

28-Jan-2019 By Melissa Fassbender

The Wasdell Group’s new EU headquarters in Dundalk, Ireland is set to commence operations later this year as part of the company’s “proactive contingency plan” ahead of Brexit.

Sartorius Stedim BioOutsource adds NBE product characterization to service lineup

24-Jan-2019 By Melissa Fassbender

Sartorius Stedim Biotech’s contract testing subsidiary is adding services offer increased support to clients developing new biological entities.

‘Sit up and take notice’: UK Parliament clamps down on universities not reporting clinical trial results

24-Jan-2019 By Melissa Fassbender

The UK Parliament is putting pressure on universities failing to publish data from clinical trials – with plans to question institutions later this year following a debrief with AllTrials, which will be monitoring compliance.