As more CROs look to divest in-house clinical trial technologies, Bioclinica has released a new Clinical Trial Management System (CTMS) sized specifically for smaller organizations.
Bracket has released several new mobile applications to support Bring Your Own Device, a clinical trial technology which allows patients to report symptoms using a smartphone.
French investigators reviewing the Phase I trial in which one volunteer died and five others were hospitalized in January have criticised CRO Biotrial over how it conducted the study.
As a significant amount of drug discoveries occur outside of pharma companies, Elsevier has launched The Hive Project to promote innovation in the market – outside its walls.
The WHO has accused Semler Research of data fraud and said Mylan, Micro Labs, Lupin and Strides and others may need to repeat bioanalytical trials conducted by the CRO.
Exco InTouch has formed a strategic partnership with Regulatory Strategies, a data protection and compliance consultancy, in response to upcoming reforms.
Heptares Therapeutics and Kymab Limited have entered into a strategic collaboration to discover, develop, and commercialize novel antibody therapeutics.
Using an experimental Internet of Things system that enables remote monitoring, the companies believe the multi-year project has the potential to change the way clinical trials are conducted.
Sekisui XenoTech announced that it now offers genotyped hepatocytes for polymorphic enzyme drug metabolism studies as part of its cell- and tissue-based product catalog.
Heat Biologics has announced several "necessary" but "incredibly difficult" cost cutting measures, including a workforce reduction of approximately 22%.
The drug industry needs to rethink what defines a ‘high-risk’ candidate say an expert calling for more detailed pharmacological studies in the wake of the BIA 10-2474 tragedy.
Drugmakers seeking to stop “commercially confidential information” being made public in trial reports will need to demonstrate the likely economic harm publishing it would cause says the EMA.
One-third of clinical-trials results in the US go unreported, according to new figures published in the British Medical Journal underlining how far the drugs industry remains from full transparency.
Synexus has bought trial site network Research Across America (RAA) in a deal it claims will give its customers access to the US market and additional study participants.
Heat Biologics will no longer enrol patients in the arm of a Phase II trial examining its cell therapy HS-410 (vesigenurtacel-L) as a monotherapy for bladder cancer.
Unchained Labs has acquired Freeslate, a provider of high-throughput solutions for biologics formulation development and small molecule chemistry – marking the company’s 4th acquisition in 12 months.
The US FDA has ordered CTI BioPharma to halt a Phase III trial of a cancer drug candidate after patients died from “intracranial hemorrhage, cardiac failure and cardiac arrest.”
Under the President’s FY 17 proposed budget request, the FDA would receive $2.743bn in budget authority appropriations – and many are frustrated with the lack of funding.
Sanofi Pasteur has launched a Zika vaccine project, levering its experience in developing vaccines for similar viruses, as the US government pushes for “intensified research.”
PRA Health Sciences will launch a recruitment and education drive for trials in the UK this spring in collaboration with advertising agency DJM Pan Unlimited.
CROs have been experiencing increased pressure to implement risk-based monitoring (RBM), and while adoption has been slow, it is gaining speed, say speakers at CROWN Congress.
Clinical trial participants willingly put themselves at risk, so a committee is proposing that data sharing be mandated before manuscript publication is considered.
India has 16% of the world’s population, 20% of the disease burden, and has contributed to less than 1.4% of global clinical trials, but the country is looking to fix this imbalance.
A study halted in France after one volunteer died and others were injured differs markedly from the disastrous “elephant man” trial that hospitalized six in the UK in 2006 according to the MHRA.
On Friday, the French Minister of Health addressed the public pledging to provide answers after one man was declared clinically dead as the result of a clinical trial gone wrong.
