505(b)(2): It’s A Different Animal
Camargo
Hot Topics > Clinical evolution
Clinical evolution
Randomised clinical trials have been the mainstay of pharmaceutical product development for decades, but will they be designed and carried out the same way in future? With trials tipped to get smaller and patient selection more complex as pharma’s blockbuster model is dismantled, interactive technologies, adaptive designs and new ways to recruit and monitor patients will come to the fore.
Round up of eClinical news
20-Jun-2012 - Outsourcing-Pharma.com presents a roundup of eClinical news, including developments at Parexel, Datatrak, and MedNet.
Trial regulation in emerging markets is now "too stringent," says new report
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.
Turn to expert providers to boost discovery in biologics, says new report
11-Jun-2012 - Outsourcing is no longer a need but a "must" to lift the flat biologics discovery industry, according to a new analysis.
Catalent continues to boost biologics offering
06-Jun-2012 - Catalent has upgraded its North Carolina, US, sterile development and analytics plant to increase its aseptic fill-finish activities four-fold in a bid to boost its integrated biologics offering.
Quintiles survey finds pharma still stuck on short-termism
05-Jun-2012 - Creation of long-term biopharma relationships is hindered by continued pursuit of short-term gains, according to Quintiles’ New Health Report.
Catalent sells US packaging biz, focuses on formulation
04-Jun-2012 - Catalent has sold its US commercial packaging business to Frazier Healthcare as part of plans to focus on “innovative pipelines”.
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.
EXCLUSIVE
Chiltern CEO reflects on 30 years in the CRO biz
28-May-2012 - More than a third of patient recruitment will be done in emerging markets in the future, predicts Chiltern CEO Glenn Kerkhof.
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.
R&D and commercial work together to design trials, says DIA
22-May-2012 - ‘CROs: look at the entire portfolio, not just the individual project, when planning clinical studies,’ says DIA’s adaptive design scientific working group.
'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.
Chiltern sets up in Taiwan
02-May-2012 - Chiltern has set up a legal entity in Taiwan that will allow it to establish its own local clinical research operations for the first time.
Almac lauds benefits of lean six sigma for IXRS biz
16-Apr-2012 - Almac says the adoption of ‘lean six sigma’ was the right move for its clinical technologies business, even taking higher initial training costs into account.
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.
Roundup of eClinical news
12-Apr-2012 - Outsourcing-Pharma presents a roundup of eClinical news, including an update at Medidata to drive growth in 2012.
Regulatory changes: the experts give us their thoughts at DIA Euromeeting
05-Apr-2012 - Regulatory reform was the name of the game at this year’s DIA Euromeeting in Denmark.
GE buys genomic services CRO
05-Apr-2012 - GE Healthcare has bought a nucleic acid technology CRO, SeqWright, to add to its range of genomic services.
Catalent eyes emerging market expansion of end-to-end development service model
04-Apr-2012 - Catalent wants to build on its European expansions by replicating the end-to-end drug development services model in emerging markets.
Biomarker expansion positions CRO for rapid growth; Edison
04-Apr-2012 - Niche CRO Proteome Sciences is poised for triple-digit sales growth as its biomarker business takes off, an investment research firm said.
'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.
Big Pharma interest shows FSP model is “alive and well”
22-Mar-2012 - The FSP model is “alive and well” with inVentiv, INC Research, and others in the hunt for sizable deals with big pharma companies.
Selecting formulation early cuts time to market, says Formac
21-Mar-2012 - Formac Pharmaceuticals and WR Grace say their silica platform can improve the formulation selection process for poorly soluble APIs (active pharmaceutical ingredients).
inVentiv to buy Kforce Clinical Research for FSP biz boost
20-Mar-2012 - inVentiv Health will stump up $50m for contract staffing firm Kforce Clinical Research (KCR) to ramp up its funcatiuonal service provider (FSP) business.
Virtual dev needs blockbusters to sway herd, proponent says
20-Mar-2012 - The virtual development model needs a string of successes or blockbusters to convince the ‘herd’ of its merits, an expert said.
