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.
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...
08-Aug-2011 - Systemedicus has developed informed consent and patient compliance apps for iPads and iPods and is looking to license the tools to CROs and sponsors.
18-Jul-2011 - Europe has proposed draft distribution guidance in response to globalisation and threats to the pharmaceutical supply chain.
05-Jul-2011 - Better designed protocols and early identification of risks can improve trial quality and help avoid warning letters, said the FDA.
19-May-2011 - Marketing applications should contain details of clinical trial ethics and be rejected if serious violations are found, said some EMA workshop participants.
16-May-2011 - Indian CRO GVK Biosciences has been named as a preferred provider by a consortium, Product Development Partners (PDP), which is focused on drugs for neglected diseases.
16-May-2011 - Indian regulators plan to standardise clinical trial serious adverse event (SAE) reporting to ensure complete data is submitted.
19-Apr-2011 - Clinical trial sites must take a proactive approach to non-compliance by identifying risks and having corrective action plans, says a former FDA investigator.
18-Apr-2011 - The FDA is planning to change clinical investigator disqualification regulations following GAO recommendations.
12-Apr-2011 - Non-clinical CRO CIT has rolled out a new suite of drug candidate toxicity and safety assays that, it claims, can provide detailed data in just 14 days.
24-Mar-2011 - Aptiv Solutions and Cancer genetics have partnered to provide biopharmaceutical developers with support for cancer trials.