CRO Profil Institute for Clinical Research will collaborate with Denmark-based Gubra ApS, a metabolic preclinical and drug discovery company, to discover and translate into clinical research novel drug targets, compounds and biomarkers addressing metabolic...
Inform Genomics has selected Icon as its contract research organization (CRO) for the pivotal multicenter study of its Hematopoietic Stem Cell Transplant (HSCT)/Mucositis product candidate.
The proportion of pediatric trials of all clinical trials in the EU continues to increase since the integration of a Pediatric regulation in 2007, despite a decrease in the number of clinical trials overall since then, according to a new report from the...
From new service offerings to manufacturing deals to more formal strategic partnerships, the world of contract research and manufacturing organizations has been busy as of late. Here’s a roundup of some of the deals and new offerings:
A recent spate of activity - including the acquisition of a Japanese CRO and a secondary equity offering - has boosted Quintiles’ investment appeal, an analyst says.
Following a re-examination requested by MAHs (marketing authorisation holders) for seven of the medicines suspended, the EMA has re-confirmed its recommendation to suspend hundreds of drugs following issues with clinical studies conducted at CRO GVK Biosciences...
In a House bill that largely mirrors one reintroduced earlier this year in the Senate, CROs (contract research organizations) would be able to capture a share of the R&D tax credit, thereby making the US more competitive with other countries that...
Adaptive clinical trial designs can be used in medical device studies as long as they are for “prospectively planned modifications based on accumulating study data without undermining the trial’s integrity and validity,” the FDA says.
Experts across the sponsor-CRO spectrum seem to agree on at least one thing: the clinical trial process is ready for a major transformation, though how quickly and what types of innovations will be adopted the fastest remains to be seen.
Quintiles has completed its previously announced refinancing in which it entered into new senior secured credit facilities totaling $1.95bn, consisting of a $500m revolving credit facility and $1.45bn of term loans.
Western CROs with a presence in Japan are benefiting from growing demand from international pharma and local drugmakers interested contractors with global reach says PPD.
With WuXi pushing full steam ahead in its bid to go private, one expert says that the company may be envious of a competing CRO -- Hangzhou Tigermed, which is smaller than WuXi but valued at a higher price on the Shenzhen stock exchange.
The debate continues over how to optimize clinical trials, with some experts calling for incremental changes to combat inefficiencies while the FDA’s deputy commissioner says the industry is at a “tipping point.”
Analyzing data on previous study performance and the complexity and design of a trial can offer earlier insights on whether a protocol is feasible, Michelle Marlborough, VP of product strategy at Medidata, told Outsourcing-Pharma.com.
The University of North Carolina at Chapel Hill and GlaxoSmithKline (GSK) are creating a new HIV research center and a jointly owned new company that will focus on discovering a cure for HIV/AIDS.
Wasting no time in furthering its lab-based JV with Quest Diagnostics the world’s largest CRO Quintiles has opened a GLP-compliant bioanalytical liquid chromatography-mass spectrometry (LC-MS) laboratory in Oss, the Netherlands.
Despite a growing interest in adaptive clinical trial (ACT) designs, few designs have been used relative to the overall number of trials conducted, and more ethical concerns need to be considered, according to a new study published Sunday from University...
A number of small, mid-sized and large CROs (contract research organizations) and other companies tied to the world of clinical research have announced various partnerships and other financial moves over the past week. Here’s a roundup of the latest:
Although Parexel’s consolidated service revenue increased by only 2% for the quarter, the company reported that its backlog included gross new business wins of $942.4m, which was 5.3% higher than the same quarter as last year.
With the aim of getting new drugs to patients more quickly, a new House draft bill released Wednesday offers a whole set of new ideas around what the NIH and FDA can do to speed drug discovery and development.
China-based contract research and manufacturing company WuXi PharmaTech has received a proposal to be taken private by a consortium led by its CEO and Ally Bridge Group Capital Partners.
As the cost of clinical trials continues to grow, Janet Woodcock, director of the Center for Drug Evaluation and Research at the FDA told Senators earlier this week that there are “ways to greatly improve clinical trial efficiency,” and cut costs through...
CRO Quintiles’ recent purchases of oncology and medical device specialist Novella and EHR service firm Encore Health Resources are starting to reap new benefits for the world’s largest CRO, the company reported in its earnings call on Wednesday.
Nearly a week since Pfizer formally announced its third CRO partner as PPD, the spotlight shifted to Icon as the CRO earns nearly one-third of its revenue from Pfizer.
With sky-high valuations and soaring M&A prices, the question of whether there’s a biotech bubble continues to crop up, though now some analysts are saying this so-called bubble and its inevitable pop may be a cause for concern for CROs (contract...
CRO INC Research saw its net service revenue increase by 14.5% to $211.5m in Q1, which was considerably higher than analyst expectations and driven by particularly strong growth in trials around CNS (central nervous system), oncology and other complex...
Just two months after Covance shareholders signed off on LabCorp acquiring the company, and all seems to be going according to plan, though financial expectations for the rest of the year were slightly lowered by the diagnostics company.
Reluctant doctors and varying reimbursement policies are affecting biosimilar trial recruitment, experts said at the European Generics Association’s biosimilars conference in London last week.
As 20 of the largest biopharma companies have now joined industry group TransCelerate, the group is beginning to use patient centricity and connectivity to influence the clinical trial environment, CEO Dalvir Gill told attendees at the Partnerships in...
As M&A continues to ramp up for the pharma and biotech industry, communication and agility are two of the major keys for CROs to adapt to an acquisition, experts said Thursday at the Partnerships in Clinical Trials Conference in Boston.
As sponsors and CROs continue the inevitable shift away from 100% SDV (source data verification) in line with US FDA and TransCelerate guidance, new risk-based monitoring (RBM) strategies are cropping up in various ways across the industry.
Pfizer has selected PPD as its third preferred contract research organisation (CRO), but the addition will not affect ongoing relationships with Parexel and Icon, the firm says.
The FDA is releasing draft guidance articulating its current policy of accepting valid clinical data obtained from foreign clinical studies in support of premarket submissions for medical devices.
Cash-strapped investigator sites seeking new ways to ensure they get paid promptly will find some new forms of relief in a recently formed Site Advocacy Group (SAG) created by INC Research and the Society for Clinical Research Sites (SCRS).
As part of efforts to reduce clinical trial start-up times, WIRB-Copernicus Group (WCG), the world's largest provider of regulatory and ethical review services for human research, said it will encourage the 1,200 members of its research network to...
EU-based Iris Pharma, an ophthalmology-focused CRO (contract research organization) and US-based Oculos Clinical Research, a full-service CRO, announced Thursday a strategic alliance that aims to help sponsors conduct more global clinical trials.
Quintiles on Thursday announced the selection of Hospital Italiano of Buenos Aires, Argentina, as the company’s first “Prime Site” in Latin America, adding to the company’s network of investigative sites worldwide.
Competition in the notoriously tight-lipped CRO (contract research organization) and CMO (contract manufacturing organization) industries is getting fiercer as outsourcing picks up, though that hasn’t stopped one Chinese company from revealing who it...
The Ministry of Health of the Russian Federation approved 151 total clinical studies in Q1 of 2015, which is 11% less than the same quarter last year, though by comparison, it’s still 10 times more than India has approved in the same amount of time.
Publishing summary clinical trial results poses no threat to patient privacy according to the WHO, which says enforcing transparency laws and incentivising sponsors is key to making sure data from all trials is reported.
