Lengthening supply chains increase the risk of patients becoming exposed to substandard or counterfeit materials in medicines, while pharmaceutical research in the post-genomic era is exposing patients to a swathe of new drug mechanisms. It is critical that patients exposed to developmental or marketed drugs are guaranteed ethical and transparent processes from industry, regulators and other healthcare organisations.
27-Jun-2012 - “Collaborate to innovate,” is the message DIA has for clinical researchers at its 2012 Annual Meeting in Philadelphia, US.
14-Jun-2012 - Regulation of clinical trials in emerging markets is now too strict and is prompting sponsors and CROs to adopt “one-size-fits-all” designs, according to a new study.
13-Jun-2012 - Clear communication between sponsors, CROs and regulators is critical to the smooth transfer of IRB responsibilities, the FDA said.
31-May-2012 - The use of home visits in clinical trials could raise the chances of regulatory approval, according to ResearchNurses.co.
30-May-2012 - Including home visits in clinical trial designs could be the key to patient retention, according to ResearchNurses.co.
24-May-2012 - A host of Big Pharma firms have come together to participate in a new forum in a bid to boost patient recruitment activities in emerging markets.
23-May-2012 - West Pharmaceutical is changing its gauge from contract manufacturing to proprietary products: it’s particular focus, delivery systems.
22-May-2012 - Quanticate says it will eliminate unnecessarily “complicated spreadsheets” in clinical trial data analysis after integrating a new simplified web-based program into its own.
16-Apr-2012 - Designing trials around patients’ habits is the key to success in patient compliance, according to online recruitment specialist Rebar Interactive.
12-Apr-2012 - Clinigene has called for more companies to consider paediatric applications of drugs from the beginning of their clinical trials.
10-Apr-2012 - The Indian regulator is adding staff and strengthening infrastructure to enforce its new clinical trial guidelines, a government minister said.
02-Apr-2012 - Inspectors are more likely to find medical care failings at CROs than sponsors, a Health Canada report found.
29-Mar-2012 - “Less bureaucracy and more research” was the Danish Minister of science and innovation’s message to regulators at this week's DIA Euromeeting.
12-Mar-2012 - The two Indian CROs implicated in US TV show Dateline’s recent undercover operation have branded the report “unfair” and “out of context”.
08-Mar-2012 - Y-Prime Technologies has launched new clinical trial management software in a bid to answer what it says is an industry outcry for simpler tech.
20-Feb-2012 - Safety concerns prompt yet another recall at troubled US CMO Ben Venue with Bedford Labs pulling its leukaemia treatment cytarabine.
23-Jan-2012 - Acurian says rapid expansion of its opt-in trial subject database is testament to the efficacy of direct-to-patient communication.
04-Jan-2012 - Publication of all clinical data and recruitment targets is needed to boost trial transparency, researchers claim.
06-Dec-2011 - Simplifying clinical trial eligibility criteria and reducing the number of recorded variables can cut risk of data fraud, statisticians said.
28-Nov-2011 - India is seeking comments on draft guidelines that detail sponsors’ clinical trial injury compensation responsibilities.
23-Nov-2011 - The EMA is recalling cancer drugs manufactured by CMO Ben Venue Laboratories after inspectors found quality shortcomings.
22-Sep-2011 - US pharmaceutical firm Eli Lilly says taking language, cultural diversity and site location into account helped boost ethnic minority participation in a recently completed trial.
15-Sep-2011 - Drug Developers struggle to find PK-PD providers that are fast and efficient says US CRO ClinPharm Consulting, after launching a new suite of services designed to cut risk and maximize...
15-Sep-2011 - DaVita Clinical Research has opened a biorepository to help drug discovery teams develop personal medicines by understanding patient populations.
22-Aug-2011 - The EMA says current GCP rules make quality management in trials too costly and need to be revised into a code that meets the needs of academics, small and midsized...