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Patient safety

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.

Big Pharma pools together to tackle emerging market woes

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.

West shifts focus to proprietary products

23-May-2012 - West Pharmaceutical is changing its gauge from contract manufacturing to proprietary products: it’s particular focus, delivery systems.

'Simplify trial data analysis and look at the bigger picture', says Quanticate

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.

Improve patient compliance by designing trials around real life, says expert

16-Apr-2012 - Designing trials around patients’ habits is the key to success in patient compliance, according to online recruitment specialist Rebar Interactive.

Keep the kids in mind when conducting clinical trials, say Clinigene

12-Apr-2012 - Clinigene has called for more companies to consider paediatric applications of drugs from the beginning of their clinical trials.

India strengthening clinical trial regulatory capacity, gov says

10-Apr-2012 - The Indian regulator is adding staff and strengthening infrastructure to enforce its new clinical trial guidelines, a government minister said.

Failures of medical care more common at CROs, report finds

02-Apr-2012 - Inspectors are more likely to find medical care failings at CROs than sponsors, a Health Canada report found.

'Regulators: Get to the point', say experts at DIA Euromeeting

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.

Indian CROs caught in Dateline sting insist report was "out of context"

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”.

Y-Prime aims to simplify clinical trial management with new confusion-free platform

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.

Another cancer drug recall at troubled CMO Ben Venue

20-Feb-2012 - Safety concerns prompt yet another recall at troubled US CMO Ben Venue with Bedford Labs pulling its leukaemia treatment cytarabine.

Acurian’s opt-in database hits 70m potential subjects

23-Jan-2012 - Acurian says rapid expansion of its opt-in trial subject database is testament to the efficacy of direct-to-patient communication.

Journals aim at recruitment & data in trial transparency push

04-Jan-2012 - Publication of all clinical data and recruitment targets is needed to boost trial transparency, researchers claim.

Simplifying eligibility criteria can cut data fabrication risk

06-Dec-2011 - Simplifying clinical trial eligibility criteria and reducing the number of recorded variables can cut risk of data fraud, statisticians said.

Indian trial compensation guidelines open to comment

28-Nov-2011 - India is seeking comments on draft guidelines that detail sponsors’ clinical trial injury compensation responsibilities.

EMA recalling oncology drugs manufactured by Ben Venue

23-Nov-2011 - The EMA is recalling cancer drugs manufactured by CMO Ben Venue Laboratories after inspectors found quality shortcomings.

Lilly boosts minority participation in trial with new systematic approach

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.

Clinpharm Consulting rejigs offering to tackle common PK-PD challenges

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...

DaVita opens biorepository to support drug discovery

15-Sep-2011 - DaVita Clinical Research has opened a biorepository to help drug discovery teams develop personal medicines by understanding patient populations.

EMA aims to spark debate on quality in clinical trials

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...

Apps turn iPads & iPods into consent & compliance tools

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.

EC drafts GDP guidance to tackle supply chain threats

18-Jul-2011 - Europe has proposed draft distribution guidance in response to globalisation and threats to the pharmaceutical supply chain.

Protocols and planning key to avoiding warning letters; FDA

05-Jul-2011 - Better designed protocols and early identification of risks can improve trial quality and help avoid warning letters, said the FDA.

Ethical aspect of trials should be part of marketing apps

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.

update

GVK to work with Gates Foundation-funded neglected disease group

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.

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