In response to demand for flexibility, Cromsource has consolidated its hybrid services model to provide customers with an alternative to fully outsourced or functional service provider (FSP) models.
The digital health company AMRA has entered into an exclusive agreement with the largest imaging CRO in Japan as part of its work to provide ‘critical informatics’ to the drug development industry.
Darmerica recalls two lots of product labeled as quinacrine, a compound used as a sclerosing agent, which were instead found to contain a treatment for malaria.
There has been a lot of discussion surrounding the use of artificial intelligence in drug development – with several deals, alliances, and partnerships made so far this year. Here, Outsourcing-Pharma takes a look back at some of these announcements, as...
BIA Separations introduces technology able to remove host-cell DNA and proteins from AAV products, aiming to accelerate clinical development of gene therapies.
hyperCore International is the first site network to receive the ‘Virtual Trial Capable’ certification after completing VirTrial’s recently launched training program.
Aetion today announced that former FDA Commissioner Scott Gottlieb has joined its board of directors to help to advance the use of RWE in drug development and commercialization.
Shimmer Research launches an initiative to develop a set of open-source algorithms and software tools for analyzing wearable sensor data – and, ultimately, standards that will be accepted by industry and regulators.
Both the FDA and EMA announce NDMA contamination of ranitidine medicines and a lawsuit is immediately filed against manufacturers for ‘concealing’ the carcinogen.
Merz announces that it has completed the construction of a new plant for its botulinum neurotoxin product and unveils a ‘robot-controlled’ filling line.
Medidata is building a global library of pre-configured, pre-approved eCOA questionnaires to accelerate study start-up in collaboration with Icon's Mapi Research Trust – “a win-win-win” for all involved.
Purdue reaches agreement to settle opioid litigation it is facing in the US by pursuing bankruptcy and providing a suggested $10bn towards the opioid crisis.
Clinerion is deploying Volv’s AI algorithms across its hospital network as part of a recently announced strategic collaboration that includes plans to bring an ‘enhanced value proposition’ to both companies’ expanded client base, says CEO.
The drug discovery and preclinical services company has moved its US office to Kendall Square as it looks to ‘sustainably grow’ its US presence and increase sales in the coming years, says SVP.
South Korea looks to accelerate review timelines and study start-up with a new five-year plan that will benefit biotechs looking for locations outside the US to ‘ramp up’ clinical development programs, says CRO.
In response to the UK government’s publication of potential ramifications of a no-deal Brexit, the ABPI responded that the pharma industry needs more details on mitigation strategies.
The pharmaceutical and biotech product development consultancy Boyds acquires Blue Duck Consulting to boost its clinical and medical affairs services offering.
Civica agrees a deal with Exela to secure the supply of sodium bicarbonate injections to distribute through its hospital network due to ‘ongoing shortages’.
The FDA has extended its agreement with CluePoints to augment the agency’s oversight of clinical trials using data-driven approaches, with additional testing ideas focusing on moderators of treatment effect and real-world evidence, says CCO.
Incorporating patient insights into clinical trial design has ‘consistently’ shown to improve timelines, though this requires involvement from all stakeholders, including physicians, who on average spend only 17.5 minutes with a patient during a single...
Patients often feel more comfortable sharing their feelings with a device than with a health care provider, found researchers at Janssen, who have developed a new voice technology application for clinical trials.
Javara, Elligo Health Research, and Circuit Clinical are leading ‘a monumental shift’ in how clinical trials are conducted through the ‘integrated research organization’ model, which is taking on traditional approaches challenged by ‘participant scarcity’...
From pilot projects to process changes, the evolution of patient centricity is affecting all aspects of drug development, say industry experts, who share best practices and lessons learned.
After ‘holding its breath’ for nearly half a decade, pharma and health care companies are ready to implement new technology in clinical trials – though data standardization will be key to fully realizing the benefits.
Fewer investigators cite patient recruitment as a top challenge in a recent report which finds investigators also more willing to participate in future clinical trials if working with a preferred central lab.
The network for clinical and imaging data launches a new ‘Real World Imaging’ offering to complement existing real world evidence – and help overcome the challenges of bias and homogeneity, says CEO.
Mallinckrodt announces a settlement agreement on a lawsuit included in the first federal trial over the opioid crisis, shortly after reaching a deal on a previous investigation.
To meet the needs of increasingly complex clinical trials, and sponsor desire for control and scalability, Covance launches an expanded FSP offering focused on delivering ‘clean data.’
The global CRO Cromsource has opened a new office in Research Triangle Park – home to many current and potential clients – after growing more than 150% over the two years, says COO.
Catalent to invest $9m in the building of an early-stage clinical supply facility in San Diego, due to open in the summer of 2020, to integrate its CDMO business.
Mundipharma signs agreement to progress an antifungal candidate through to commercialization, with the potential for it to become the first approved treatment in 13 years.
Increasingly complex clinical trials are putting pressure on CROs to expand their service offerings in what has been a historically monolithic space – with diagnostics also continuing to play a more important role in the market, says industry expert.
Organizations or individuals desiring change is often the reason for retirements, but the timing is often crucial and so it proved for two major institutions in the UK.
Advarra is set to acquire Forte in a bid to expand its offerings to include an integrated suite of standards-based trial management products and services – a platform for ‘an interconnected clinical research ecosystem,’ says CEO.
Velesco to triple its capacity for non-sterile clinical material manufacturing and consolidate its cGMP capabilities with the purchase of a facility in Wixom, Michigan.
The acquisition of Bioclinica’s clinical research site business extends PPD’s trial enrollment business to five continents, 20 countries, and more than 180 research sites.
The Canadian CRO Everest Clinical Research will receive up to up to $100,000 to support the development of new technology for managing data from clinical research trial sites.
