CRO (contract research organization) Icon reported its highest level of quarterly bookings ever on Tuesday and the company’s stock jumped by about 15%.
CRO (contract research organization) PRA Health Sciences reported in its earnings call on Tuesday that earlier in Q2 it acquired Value Health Solutions (VHS), a clinical development software company, for $2.5m.
A surge of demand in biologics contract testing and biosimilar characterization has caused BioOutsource to double its capacity with the opening of a new facility in Glasgow, Scotland.
As the number of approved clinical trials in India continues to taper off compared to years past, a government task force is now calling for a new expedited trial approval process.
Investor backing puts transparency on the pharma agenda says SenseAboutScience, even though none of the funds pledging support for Alltrials have committed to pull investment from drug firms that disagree.
A new four-year research project involving a consortium of government, non-profit and other large biopharma partners is aiming to create a set of measures that can be used in clinical trials to determine which ASD (autism spectrum disorder) treatments...
In an industry with high employee turnover rates, CROs (contract research organizations) are now turning to new, creative ways to try to recruit and retain top talent.
Full-service CRO (contract research organization) Frontage Laboratories has acquired a 45% stake in BDM Consulting to expand its offerings in biostatistics, data management and SAS (statistical analysis system) programming.
France’s AB Science has received a warning letter from the US FDA for its failure to adhere to agency regulations and to protect trial subjects’ safety in a pancreatic cancer study and GIST (gastrointestinal stromal tumor) studies from 2009 to 2013.
The latest EMA (European Medicines Agency) report on GCP (good clinical practice) inspections reveals that deficiencies around SOPs (standard operating procedures), sponsor monitoring, data management, and essential documents linked to trials were most...
With an exclusive board of directors and now some funding, Nuvelution Pharma is looking to get its risk-sharing clinical trial venture for late-stage candidates off the ground and will engage with CROs (contract research organizations) in the near future.
DNA-based diagnostics company Cancer Genetics has partnered with the lab services group of CRO Icon to provide clients with new offerings, including oncology-focused genomic testing, central lab analysis, project and data management, and sample logistics.
With an overwhelming majority, the House on Friday morning passed a new bipartisan bill that would increase NIH funding by about $8.75bn and the FDA by $550m over the next five years.
Epic and LabCorp’s Covance have agreed to extend their partnership to provide circulating tumor cell (CTC) technology and oncology clinical trial support in Asia.
With a House floor vote looming this week, legislators will decide on a revised bill that has decreased the amount of funding that will go to the NIH from the original bill, and removed a section that would have required NIH grant recipients to share...
CRO Pharmaceutical Product Development (PPD) has formalized relationships with eight investigator sites to create a pediatric investigator network (PIN) as part of efforts to speed trial startups, more predictably enroll patients and offer higher quality...
In another setback for Alzheimer’s drug developers, European CRO/biotech Evotec and partner Roche have announced that their candidate did not meet its primary endpoint after 52 weeks treatment in a Phase IIb study.
BioClinica has opened offices in London and Munich to provide its European clients with expanded clinical trial services including medical imaging, site training and support, and eClinical product lines.
Aeterna Zentaris has selected UK-based Ergomed again for a clinical trial, this time for a confirmatory Phase III study to demonstrate the efficacy of Macrilen (macimorelin), a novel orally-active ghrelin agonist for use in evaluating adult growth hormone...
Bracket Global has acquired Boston-based Clintara, which will allow Bracket to integrate the Clintara platform of trial surveillance tools into its electronic platform for Clinical Outcome Assessments (eCOA).
The Clinical Trials Transformation Initiative, a public-private partnership between Duke University and the FDA, has created a list of four recommendations related to quality by design (QbD) for clinical trials.
Two early adopters of RBM (risk-based monitoring) – Bristol-Myers Squibb and Celgene – have provided details into the way they’re reducing clinical trial site visits to increase efficiencies around identifying risks earlier and more efficiently.
The 51st annual DIA conference in Washington, DC has been abuzz all week with new offerings from the top CROs (contract research organizations), in addition to new collaborations between top sponsors and academic institutions. Here’s a rundown of the...
With more than 90% of revenue coming from pharma and biotech companies outside the top 25, CRO SynteractHCR is seeing more growth stemming from an influx of funding to smaller biotech companies, CEO Wendel Barr told us on the third day of the 51st annual...
The pharma industry must fight “vendor indifference” so suppliers and services companies are not prey to cyber attacks that can lose drug companies hundreds of thousands of dollars in minutes, according to US Homeland Security’s former head of cybercrimes...
Last month, a US House committee unanimously passed a bill that would set up a host of new provisions tied to clinical trials, many of which will have an impact on the way contract research organizations (CROs) operate.
Trade secrets proposals supported by the European Parliament’s legal affairs committee could allow drugmakers to withhold trial results and drug safety data says Health Action International.
A new trial model is needed to encourage cardiovascular disease drug development say researchers who claim the large, lengthly studies used to prove safety and efficacy of such drugs are a disincentive.
CRO Pharmaceutical Product Development (PPD) has established a five-year partnership with Anthem subsidiary HealthCore to help sponsors more quickly and effectively demonstrate how their products will perform in the real world.
Competition among the top CROs, many of which are conglomerations of smaller peers, is “ferocious” right now on nearly every level, Parexel CEO Josef von Rickenbach told Outsourcing-Pharma.com at the 51st annual DIA conference.
Akebia Therapeutics has signed a master services agreement with CRO Quintiles in connection with its planned Phase III studies for Akebia’s lead product candidate for the treatment of anemia secondary to chronic kidney disease in non-dialysis patients.
As the hype continues to hover around the promise of gene and cell therapies, the latest guidance from the FDA will help sponsors, CROs and investigators design early-phase clinical trials for the products, which may pose substantial risks to patients.
As biotech cash continues to flood the coffers of CROs (contract research organizations), large pharma R&D is still relatively flat, which means CROs will see about 6% growth annually, Brendan Brennan, CFO of Icon, told investors last week at the...
The 21st Century Cures Act may actually offer the FDA too much discretion to approve drugs without conventional clinical trials, and in some cases “on the basis of less rigorous data,” two medicine professors from Harvard write in an editorial in the...
Last week, a new chapter of PhRMA’s Principles on the Conduct of Clinical Trials and Communication of Clinical Trial Results went into effect, detailing efforts to raise awareness around expanded access programs, which provide investigational drugs for...
Full-service CRO (contract research organization) Veristat will move its corporate headquarters from Holliston, Massachusetts, to Southborough, Massachusetts, this summer as the company has outgrown its old space.
