Clinical Research Advantage (CRA) has acquired the late phase business of Comprehensive Clinical Development (CCD) adding psychiatric clinical trials to its services.
The days of using Excel spreadsheets to manage clinical trial site payments are now in the past, especially as CROs and sponsors look to retain their most highly-prized sites and establish long-term relationships for future trials.
Chiltern has a new Director of Global Pharmacovigilance and there's an appointment at DSM in this week's lowdown on the outsourcing industry's movers and shakers.
Specialist tablet dissolution-focused preclinical CRO SPS Pharma Services has started operations at its new French HQ and plans to expand its offering.
Industry bodies say they support the sharing of trial data following allegations yesterday they used patient groups to lobby new EU transparency regulations.
Dry powder inhaler firms may soon be able to eliminate lactose from formulations if a new high dispersibility particle production platform is successful in trials.
Integrated DNA Technologies (IDT) has opened a facility in Singapore in order to manufacture oligonucleotides for research companies throughout the region.
Europe may soon approve the first biologic made according to quality by design (QbD) principles, but opinions are still split over whether the approach should even be applied to biopharmaceuticals.
Appreciating warm alcohol, like being rubbish at cricket, is no longer a solely British preserve with researchers in Australia developing a hot ethanol-based manufacturing method that, they claim, produces smaller, more uniform API particles.
With the Chinese NAP (nucleic acid purification) market expected to grow more than 8% over the next year and no clear market leaders, companies are looking to take control of the industry space.
Biopharma firms, particularly those producing insulin and five of its analogues, have another option in the market of sub-2 micron solid-core chromatography columns with a recent offering from Waters.
The current US shortage of tetracycline is not likely to be resolved any time soon because of ongoing manufacturing and raw material supply issues according to the US FDA.
China’s top CRO Wuxi Apptec has purchased a remote clinical trial monitoring tool that will allow its toxicology clients log onto a secure Web site to view data from on-going studies.
The US FDA has sent Wockhardt a warning letter for its manufacturing plant in Waluj, India just days after UK authorities issued the site with a certificate of non-compliance.
US CBO claims that proposed track and trace legislation will not be too expensive for drugmakers already used to similar laws in California are ‘misguided’ according to an industry consultant.
Despite questions over India’s regulations governing clinical trials, the largest CROs in the world do not seem deterred from running trials there, according to a recently released list of global trial approvals from 2012.
A US FDA investigation of CRO PPD did not uncover any violations that might prompt a Form 483 for its work related to Bristol-Myers Squibb’s approved drug, Eliquis.
Charles River Laboratories has partnered with eCRO Target Health and Theorem Clinical Research to support the transfer and validation of assays supporting the CROs’ preclinical programs.
As GlaxoSmithKline, Bristol-Myers Squibb and Novartis are embroiled in alleged bribery and data falsification in Asia, CROs will have to a take a hard look at whether their investments in the region will pay off as quickly as they once thought.
Analysts from rating agency Moody's have upgraded their view of Quintiles, the world’s “largest pharmaceutical service provider,” from stable to positive.
WuXiPRA, the new China-based joint venture between the two CROs, has named contract research veteran James Pusey, MD, as president and general manager.
Computational biology firm Blackfield has won its fourth Big Pharma contract in a year, with Anglo-Swedish drugmaker AstraZeneca signing up for its genomics services
Chinese understanding of European CEPs is good, but some manufacturers are still unclear on the related obligations and requirements according to auditing firm, blue inspection body.
Molecular Profiles has received the regulatory thumbs up on a second manufacturing facility and says it can offer its clients a breadth of services uncommon for CMOs.
The FDA has proposed a rule to allow its inspectors to detain adulterated or misbranded drugs found during an inspection for a short period of time and until the appropriate action is undertaken.
The EFPIA has selected software firm Solidsoft for its anti-counterfeit European Medicines Verification System (EMVS) powered by Microsoft's cloud-based platform Windows Azure.
Over the next 10 years CMO Corgenix will contract manufacture EDP Biotech’s diagnostic test to detect the early stages of colon cancer, the companies agreed last week.
Primate research is still vital to drug development say CROs after US NIH announces plan to reduce the number of chimps it uses in preclinical testing.
Simple steps to secure Rwanda’s pharma supply chain may serve as an example for other larger African countries looking to curtail the spread of falsified or substandard drugs, experts say.
CRO Theorem Clinical Research says new Emergo alliance is part of an effort to become the go-to outsourcing partner for medical device developers seeking long-term data.
