Non-profit R&D organisation Battelle is investing $200m in its facilities in Ohio, which will see the company’s contract research capabilities upgraded.
Senator Richard Moore has criticised transparency laws in Massachusetts, US, which he claims allow pharmaceutical companies to hide payments made to physicians conducting clinical trials.
The rise in international, multi-centre clinical trials has complicated reporting pathways and led to institutional review boards (IRBs) being overloaded with adverse events, according to FDA guidance.
A FDA warning letter has been sent to a clinical investigator who administered incorrect doses of investigational drugs having taken the patient’s weight and height from their driving license.
A US HHS report on FDA oversight during trials has found that, with current procedures, the agency cannot tell whether drugmakers are disclosing complete financial information from all investigators who worked on a particular study.
Cincinatti, US-based clinical research organization Kendle has cut back its revenue expectations for 2008, primarily as a result of the strengthening of the US dollar, in common with some of its peers in the CRO sector.
Contract research organisation Bio-Imaging Technologies has decided to sell off its CapMed subsidiary in order to focus its efforts on its core business, providing imaging series to clinical investigators.
The proportion of global clinical trials conducted In India is expected to more than double between 2007 and 2012, according to market research firm RNCOS.
Clinical laboratory services company LabCorp saw its shares slide yesterday after cutting back its sales and earnings targets for 2009 in light of the economic downturn.
In silico R&D specialist Entelos has entered into an agreement with the US Food and Drug Administration to use its PhysioLab to assess the safety and efficacy of cardiovascular drugs.
Canadian contract services company MDS Pharma Services reported disappointing results in its fiscal fourth quarter, with revenues dropping 9 per cent to $112m.
Contract research organisation PharmaNet Development Group is considering a sale of the business as it tries to recover from a difficult year marked by shrinking revenues and cancelled contracts.
Dr. Michael Butler has joined Xceleron as chief executive bringing an end to a search to replace Prof Colin Garner, the firm’s founder, who is retiring from the post.
There is no formal requirement to inform clinical trial participants of the results of the study, a situation which can leave them “confused, frustrated and, in some cases, lacking information that may be important to their health,” according to a report...
PPD’s admission to the Nasdaq’s 100 index, which covers the elite group of non-financial firms to be listed on the Nasdaq Stock Exchange, is a definitive moment for the CRO, according to CEO Fred Eshelman.
Parexel has made a bold foray into the troublesome arena of stroke drug development via an alliance with Safe Implementation of Treatments in Stroke (SITS) International, an international network of clinical sites geared up to recruit stroke patients.
Contract research organisation PRA International has signed an agreement with fellow US firm Frontage Laboratories to expand the range of laboratory services it can offer to its clients.
Troubled contract research organisation Encorium Group finally published its delayed financial results yesterday, posting a net loss of $3.9m, three times the year-earlier loss.
An open-source software suit for electronic data capture (EDC) in clinical trials – OpenClinica - is starting to see a dramatic rise in usage, according to its developer Akaza Research.
Chinese CRO Tigermed Consulting has teamed up with Russian and South Korean counterparts OCT and LSK to establish a global clinical trials network and expand its geographic footprint.
The proportion of women in clinical trials has become more representative, although there are still areas for improvement, according to research by the FDA.
Clinical research organisation Encorium has postponed the release of its third quarter results but said it still expects the figures to be in line with its most up-to-date guidance.
India’s Jubilant Organosys has bolstered its mid-range contract research portfolio by buying Canadian electronic data capture (EDC) specialist TrialStat ClinicalAnalytics.
eClinical specialist etrials Worldwide saw its losses quadruple in the third quarter on the back of a dip in revenues and financial charges, including a $4m asset impairment charge related to goodwill.
One of the obstacles to the development of Poland’s clinical research market is due to be removed next month, according to local consultancy firm Polish Market Research.
Recent European legislation designed to increase the number of children in clinical trials has had a positive impact in ensuring that paediatric patients are included in medicine testing.
A UK development think-tank has warned against a knee-jerk reaction against conducting clinical trials in India, following the revelation a few weeks ago that dozens of children had lost their lives in studies conducted at a contract research facility.
The world-reknowned Mayo Clinic has decided to shut down its Mayo Clinical Trial Services unit, saying it has been unable to compete in a marketplace shifting towards “low-cost, routine trials.”
Kendle International has posted impressive third quarter results, despite seeing a dramatic increase in the number of contract cancellations during the period.
Cost pressure and the increasing complexity of trials is forcing drugmakers to increasingly turn to outsourcing experts for clinical development, according to a Kalorama Information report.
An expansion of pilot plant facilities at its operations in Aurangabad, India will help Albany Molecular Research (AMRI) strengthen its position in the Asian drug development sector, according to CEO Thomas D’Ambra.
Contract research organisation Parexel posted a 26 per cent hike in first quarter revenues to $263m but still failed to meet its own internal sales targets and saw net profits slide.
Clinical research specialist PharmaNet Development Group reported a decline in both sales and earnings for the third quarter but has kept its guidance for the financial year at the same level, albeit excluding an as-yet unresolved impairment charge.
Irish contract developer and service provider Icon is not seeing a slowdown in business from biotechnology firms despite global downturn, according to CEO Peter Gray.
Covance has defied challenging market conditions and posted positive results for the third quarter, with the company believing more major R&D outsourcing contracts are a possibility.
Patheon hopes that a new pharmaceutical development services (PDS) suite at its facility in Whitby, Ontario will complete its “Quick to Clinic” offering and provide a rapid-response means of making solid dosage forms for trials.
Increasing bureaucracy in clinical research in the UK is posing a threat to the industry, according to a report published in the British Medical Journal.
Contract drug development company Azopharma Product Development has set up a new business unit to cater for companies wanting to run microdosing or so-called Phase 0 studies.
Pharmaceutical Profiles of the UK has completed a groundbreaking study that bundles together a number of tests used to decide whether a drug development candidate is worth pursuing into a single clinical trial.
Cancer drugs could enter clinical trials and ultimately reach cancer patients faster thanks to legal contract templates created by the CEO Roundtable on Cancer.
Contract research organisation PPD will have to forego a scheduled $25m payment from Takeda of Japan in the fourth quarter after the US Food and Drug Administration (FDA) held up approval of a product for diabetes.