Big pharma industry group TransCelerate discussed but ultimately decided against allowing CROs to join the collaborative, though research contractors will be engaged routinely, members of the group said.
As CROs and sponsors look to use risk-based monitoring more for clinical trials, the role of clinical research associates (CRAs) will shift dramatically, experts said Wednesday.
A year after CRO Parexel saw what its CEO called “hyper growth,” the Massachusetts-based company is seeing revenue gains return to relatively normal levels.
Novartis has called in a third party organization to review how it conducts clinical trials in light of the adverse event reporting scandal that broke in Japan last week.
CRO BioClinica will acquire Blueprint Clinical, which offers a cloud-based site scoring tool to help pharma address risk-based monitoring strategies for trials.
The European Medicines Agency (EMA) has abandoned plans to stop researchers downloading clinical trial data but the European Ombudsman says she is unaware if other limits on transparency remain.
Phase II and III research is expected to see the biggest upturn in terms of outsourcing from large and medium-sized pharma, according to a survey from the Life Sciences Strategy Group.
Following its merger with RPS, as well as a number of other acquisitive moves, CRO PRA will now be known as PRA Health Sciences and will look to continue to establish itself as a top 5 CRO in the world.
The EMA is being criticised on two fronts with some suggesting its trial data publication plans will drive away drug R&D while others argue the agency is backtracking in a way that will hinder public health research.
When it comes to pharma acquisitions size does matter, according to analyst Ross Muken who says the momentary lapse in megamergers means business as usual for CROs.
The US Food and Drug Administration (FDA) has launched openFDA, a programme allowing web developers and researchers to access “massive” datasets on adverse effects and to use them to build their own applications.
Transparency campaigners have called on the EMA (European Medicines Agency) to rethink regulations set to be approved on Thursday that they say will severely limit clinical trial openness.
Bureaucracy is the biggest problem in accessing the Brazilian clinical research market, according to local CRO Techtrials, who says its expansion into the US was a far easier procedure.
Clinical trial patients who share their experiences on social media may “unblind” clinical trials, Pfizer’s head of Clinical Innovation for Worldwide R&D has said.
As big pharma and biotech companies increasingly take R&D centers offline, the companies are also looking to reduce the number of outsourcing partnerships, Jim Foster, CEO of Charles River Laboratories, said recently.
Bristol-Myers Squibb (B-MS) announced a five-year extension to its drug discovery and development collaboration in the subcontinent with Syngene International, India's largest CRO.
A UK software maker has launched an iPad tool it says ends the need for CROs (clinical research organisations) to hire trained neuropsychologists to measure drugs’ effects on the brain.
As biotech funding saw one of the strongest quarters since 2004, Covance CEO Joe Herring predicts that the CRO industry is poised see an even higher percentage of biopharma R&D to be outsourced.
The Life Sciences Strategy Group has launched a new website for biopharma outsourcing professionals, which includes a star-based user ratings program for CROs that’s similar to Yelp’s ratings system of restaurants.
A few months after announcing its arrival in South Korea, Celerion and the Korean Drug Development Fund (KDDF) have agreed to collaborate to provide drug development expertise and support for the emerging industry.
CRO inVentiv Health Clinical and biotech sponsor Advaxis have entered into a global master services agreement for the clinical development of potential immunotherapies.
CRO INC Research has inked a two-year partnership with the Society for Clinical Research Sites (SCRS) to become a more active voice in the site investigator community.
Evotec has acquired all shares in UK-based specialist CRO Euprotec for as much as $5.26m to add anti-infective drug discovery services to its offerings.
Clinverse, a company which automates the financial lifecycle of global clinical trial providers, and eClinical Insights, a provider of cloud-based clinical trials software, have formed a strategic partnership to offer an integrated tool for clients.
A new tool will enable clinical trial heads to control drug supply and monitor patients and sites with their smartphones, according to tech firm Endpoint.
Clinical biomarker service company Targos is partnering with Wuxi PharmaTech to provide know-how, services, and quality standards to support Wuxi's bioanalytical work for biopharma customers.
The US FDA has issued final guidance on the transferring of clinical studies between IRBs (institutional review boards) in order to help ensure that serious disruptions in clinical trials are rare.
Medidata will provide metrics and analytics help to industry group TransCelerate to answer questions on the benefits and challenges associated with a risk-based approach to monitoring of clinical trial sites.
Outsourcing-Pharma.com reached out to contract testing supplier BioOutsource to see what its take is on biosimilars now that the FDA’s draft guidance on biosimilarity has been released. The following is a lightly edited interview with BioOutsource’s chief...
Horizon, which supplies genomics research services, has bought cell-screening business CombinatoRx from Zalicus for £4.74m ($8m) and plans more acquisitions.
In a letter to the EMA (European Medicines Agency), the European Ombudsman Emily O'Reilly has expressed concern that a significant change of policy on trial data transparency could limit the amount of data that becomes available.
In an industry first, bioanalytical CRO Tandem Labs has announced the availability of biomarker assays for human clinical studies using the Meso Scale Discovery V-PLEX biomarker platform, which have been already validated by Tandem in human serum.
For the first time ever, Charles River Laboratories is seeing its biotech revenues eclipse its pharma revenues, Jim Foster, chairman, president and CEO of CRL, told participants at the Baird Growth Stock Conference last week.
A few clinical trial cancellations seem to be the cause behind Covance’s weaker-than-expected growth in the last quarter, Joe Herring, chairman and CEO of Covance, said.
CRO Quintiles on Monday announced that it has signed an agreement to acquire Encore Health Resources, which offers health-information analytics and electronic health record (EHR) services.
Chinese CRO Tigermed has entered a definitive agreement to acquire a majority stake in the ownership of CRO Frontage Laboratories for $50.25m in cash, some of which the company will use to expand clinical capacity in New Jersey.
As part of an effort to provide more certainty, India’s CDSCO (Central Drugs Standards Control Organization) has offered up a new compensation formula for trial participants who are killed or injured during a trial.
CROs (contract research organizations) are more likely than sponsors to report frequent application of QbD (quality by design) principles for clinical research, though neither group seems particularly comfortable with QbD yet, according to preliminary...
As the Pfizer-AstraZeneca mega-merger seems to be pushing towards a deal, early phase CROs may be the first to suffer for a short period of time directly after the merger is complete, some say, while others don't seem to think there will be much...
Medpace Laboratories, Singapore will serve and support new and existing Medpace pharmaceutical clients conducting clinical research in the rapidly expanding Asia Pacific region.
Vince & Associates, a contract research organisation (CRO) conducting early stage and complex clinical trials, is building a $5m expansion designed to recruit and retain volunteers.
Quintiles and Covance have re-iterated previous CROs’ upbeat stances on the prospect for further pharma M&A as they both reported revenue growth for the quarter.
The recent rumours of mega-mergers are behind a sudden drop in the share value of contract research organisations (CROs) but should bring long-term benefits, says an analyst.
The relationship between private equity (PE) management and that of its CRO is “pivotal,” according to the Chairman of one pharma group, as PE’s undefined objectives and exit strategies are leaving sponsors uncomfortable.
