An evidence-based approach to planning during protocol development is key to successful patient recruitment according to Joseph Kim, director of clinical operations at Shire Pharmaceuticals.
In June global drug giant Pfizer began what it described as the world’s first ‘virtual trial’ using mobile technology to collect data from patients in their own homes rather than at research sites.
PPD posted an improved set of financials for Q2 days after announcing a review of its long-term plan and capital structure following speculation it was looking for a buyer.
India’s Central drugs standard control organisation (CDSCO) has issued new draft guidance of clinical trials and new drug approvals that pave the way for potential electronic submissions.
US CRO Parexel says the pharmaceutical industry’s desire to access international markets is the key challenge facing regulatory experts in the contract research sector.
Chiltern says that strategic partnering in the contract research sector enables CROs to plan for the longer term and is having a tangible impact on brining drugs to market.
Indian contract research organisation (CRO) GVK Biosciences has signed a deal allowing pharmaceutical researchers across the US to access its clinical biomarker database.
The fall in the number of trials conducted in Russia in Q1 is a ‘temporary blip’ says Synergy Research Group general manager Igor Stefanov, who cites recent changes to the approval process, rather than a drop in demand, as the key factor.
Pfizer has begun what it claims is the world’s first ‘virtual’ trial and says that such innovation is needed to make sure clinical research is sustainable.
ACRO has welcomed new draft guidance on SAE reporting in trials issued by India's CDSCO, but has raised some concerns about the determination of causality and compensation.
The US Association for the Advancement of Medical Instrumentation (AAMI) has adopted the latest version of the ANSI14155 standards for medical device trials.
Clinical Financial Services (CFS), a US financial management company specialising in clinical trial management, has launched its new Site Activation Services offering, designed to ‘streamline and automate’ the trial activation process.
Quintiles has signed a deal with Population Genetics Technologies (PGT) that, it says, will bring large-scale genomics analysis into the drug development mainstream.
India’s Veeda Clinical Research has set up a Phase I unit in Malaysia, joining the growing list of contract research organisations (CRO) attracted to the country.
Pharma industry wishful thinking and the fact too many developers have been chasing too few targets are behind an increase in Phase II failures in recent years according to a new study.
Tax benefit from the sale of its US Phase I business helped CRO Charles Rivers Laboratories (CRL) to grow profits in the first quarter despite falling revenues and low demand.
eResearch Technologies (ERT) posted first quarter gains after the contribution from recently acquired respiratory biz and cost controls helped offset a higher project cancellation rate.
Drug developers are pursuing new strategies to help improve the operational efficiency of their clinical trials, according to a panel of industry leaders recently convened by the Tufts Centre for the Study of Drug Development (CSDD) in Boston, US.
Clinical trial sites must take a proactive approach to non-compliance by identifying risks and having corrective action plans, says a former FDA investigator.
Algorithmic Research (ARX), the digital signature specialist, has released a short video to highlight the benefits of using digital signature technology in clinical environments.
Adaptive clinical design can lead to significant time savings when implemented successfully, claims a new study by Cutting Edge Information, the North Carolina, US-based business consultancy firm.
Perceptive Informatics, an eClinical solutions provider, has announced the results of a survey to find out what the biopharma industry considers the most important eClinical attributes.
