Collaboration and cross-selling across Syneos Health's clinical and commercial organizations drove a record quarter marked by new strategic relationships as customers look to increase outsourcing in response to pricing pressures.
PRA Health Sciences’ Q2 revenue is up 35%, as the CRO accelerates integration plans with Symphony Health and predicts an increase in staff towards the end of the year.
Modeling and simulation can provide “meaningful prediction” of a drug’s pharmacodynamic range and maximum dose – the use of which might have prevented the tragic outcome of the BIAL 10-2474 trial in 2016, says Certara VP.
Revenue growth has taken off, driven by steady start-up on several programs, as the CRO remains focused on its core market of small and midsized biopharma – which makes up the majority of its revenue.
Robotics and automation will help improve the clunky and expensive clinical trial process, says Icon CEO – as the company continues to evaluate potential opportunities to improve efficiency.
Outsourcing-Pharma recently conducted a second ‘state of the industry’ survey to gauge views about the current state of the global pharmaceutical outsourcing market and the evolving relationships of those involved.
TransCelerate and BioCelerate have launched a new data sharing platform to connect preclinical and clinical information to help better inform clinical trials.
LabCorp signed several partnership deals in the second quarter of 2018 as the company aims to enhance the drug development process and continues to invest in its CRO business.
Iqvia recently announced its second quarter 2018 results, which came in “above the high end” of the company’s expectations at $2.567bn, said CEO Ari Bousbib.
Repeal of the hotly debated medical device tax would free up research and development resources and bring clinical trials back to the US, say CRO industry executives.
Accelovance and Linical merged in March of this year to create a global midsized CRO for which ‘future possibilities are endless,’ says newly appointed CEO.
The FDA guidance addresses EHR data use in clinical trials – and while “one of the most prescriptive in recent memory” – does not solve interoperability challenges or address other sources of data, such as wearables.
The EMA has revealed that it is having to cope with “significant staff losses” due to Brexit, which means that it will have to temporarily cut certain activities.
Less is more as it pertains to data collection in oncology trials, says industry expert, with ePRO use expected to grow significantly over the coming years.
The Alliance for Clinical Research Excellence and Safety (ACRES) has released a global quality standard for clinical research sites aimed at increasing data accuracy and integrity.
CTTI’s latest recommendations will help researchers deploy mobile technologies in clinical trials and “pave the way for improving how we develop medicines,” says Pfizer exec.
Pan-American countries should adopt EMA-style regulations to increase clinical trial transparency and streamline research, according to a recent report.
The industry needs “to strike a balance” between science and feasible execution as increasingly complex clinical trial protocols are impeding efficiency and driving up costs, says industry expert.
PPD has expanded its central lab technology capabilities with the launch of a new client portal and a companion application for its Preclarus investigator site portal.
The digital health startup ObvioHealth has launched a new mobile clinical study platform to streamline patient recruitment, reporting, and post-marketing surveillance.
Synexus is looking to register 30,000 adults for a five-year study with the goal of identifying potential prevention methods and possible treatments for Alzheimer’s disease and other dementias.
Pfizer, AbbVie, and GlaxoSmithKline are among the members of a clinical trial data-sharing and analytics platform designed to speed up the discovery and development of new treatments.
CRO executives are being urged to write letters of support for more high throughput clinical research centres in the UK, which could help attract foreign investment, says IAOCR.
The US FDA has released draft guidance documents on gene therapy programmes, which “should help sponsors avoid expending time and resources on unproductive drug development efforts,” says expert.
Genstar Capital, the private equity firm behind Bracket, has purchased CRF Health in a deal that will create a combined organization with more than 1,500 employees globally.
The industry is increasingly engaging in collaborations to gain access to technology, such as AI, which is being touted as a potential solution to some of the most challenging aspects of running clinical trials.
Ignoring pediatric considerations is no longer an option for the development of new medicines – though clinical trials in children are still not widely accepted by society, explains industry executive.
“Arbitrary upper age limits for trial entry are almost never justified,” says FDA, which has renewed its efforts to include older adults in clinical trials and tackle some of the key enrollment challenges.
While senior citizens consume roughly one third of all medications – and make up only 13% of the population – factors that complicate geriatric clinical trials leave gaps in knowledge and developments.
It has been nearly 20 years since a currently available drug was tested and approved specifically for the newborn population, say industry experts who are calling for education and policy changes to address the needs of this special patient population.
WCG and InformedDNA have established a new center for genetics and precision medicine in clinical trials – the increasing complexity of which, while potentially daunting, also creates the opportunity for transformational value, say industry experts.
The Scientist.com and HealthEconomics.com partnership connects real-world evidence (RWE) and health economic outcomes research (HEOR) sponsors and providers to help democratize pharmaceutical research, says company exec.
The Russia-based CRO Atlant Clinical has received certification in the organization and management of clinical trials – demand for which continues to increase despite political and economic challenges.
Velos has released a new clinical research analytics platform in which the source information is reorganized and reclassified to make it “considerably more useful for clinical research,” says CEO.
Synteract has acquired the dermatology CRO Cu-Tech, opening a fifth center of development as part of its strategy to develop “highly-expert therapeutic areas of focus,” says CCO.
The need to improve visibility, enable faster study execution, and improve study quality, is driving the industry to unify its "broken" clinical trial operating environments, according to a report.
Gemphire Therapeutics tapped the Canton, MI-based contract research organization (CRO) MMS Holdings to help support a Phase IIb clinical trial of its first-in-class drug candidate, Gemcabene.
