505(b)(2): It’s A Different Animal
Camargo
Hot Topics > Patient safety
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.
EXCLUSIVE
Home visits = regulatory thumbs up? ResearchNurses.co thinks so
31-May-2012 - The use of home visits in clinical trials could raise the chances of regulatory approval, according to ResearchNurses.co.
EXCLUSIVE
Home visits are the key to patient retention, says ResearchNurses.co
30-May-2012 - Including home visits in clinical trial designs could be the key to patient retention, according to ResearchNurses.co.
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.
