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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.

News from CPhI

Aesica ramps up HPAPI capacity to meet industry demand

07-Nov-2012 - The technical challenge posed by potent APIs means drug industry demand for R&D-scale contract manufacturing is largely unmet, according to Aesica.

News in brief

Catalent aims to boost drug delivery through industry-academia partnership

18-Oct-2012 - Catalent has established a new institute in a bid to advance drug delivery by creating links between industry and academia.

Industry too afraid to include children in clinical trials, says expert

10-Oct-2012 - The pharma industry does not include children in clinical research for fear of mentally scarring them, according to ResearchNurses.co.

Icon and South Korean Government team up to drive clinical activity

04-Oct-2012 - Icon has forged an alliance with the South Korean Government in a bid to boost local trial activity.

Quintiles set to boost Scotland's "promising" clinical trials market

02-Oct-2012 - Quintiles has forged a deal with the Scottish Government which it says will boost clinical trial activity in the country.

WorldCare Clinical launches clinical trials review service at request of FDA

02-Oct-2012 - WorldCare Clinical has launched a blinded independent safety and efficacy review service to speed FDA approval of clinical trial data.

EXCLUSIVE STUDY

Open source paradigm could swipe biz from CROs: Beroe

27-Sep-2012 - Open source drug developers could swipe business from CROs in the drug discovery field, according to Beroe.

Clinical trials should involve the elderly more, say experts

19-Sep-2012 - Geriatric patients are left out of trials too often say experts who want researchers to 'open their minds' to the benefits of recruiting the elderly.

Improving Biopharma R&D efficiency a mixed blessing for CROs

06-Sep-2012 - Improving efficiency in biopharma research is a “mixed blessing” for contract research organisations (CROs), according to Wells Fargo.

Online drug accountability systems will replace paper, says Cenduit

04-Sep-2012 - Automated drug accountability systems are becoming “the norm” in clinical trials because they can improve compliance and cut working time drastically, according to Cenduit.

Is cloud computing hot air? Comprehend Systems shoots the breeze with OSP

23-Aug-2012 - Comprehend Systems recently made its data analytics, visualisations and reports software available from the cloud. CEO Rick Morrison spoke with Outsourcing-Pharma.com about the firm’s reasoning, and why no rockets were...

Changes to EU clinical trial laws will mean fairer playing field, says Clinipace

21-Aug-2012 - The proposed changes to European clinical trial regulations accepted by the European Commission (EC) in July  will put Europe on an equal playing field, according to Clinipace’s Andrea Schiefer....

DaVita opens PI facility for kidney research

20-Aug-2012 - DaVita Clinical Research has opened a Phase I facility focussed on kidney research in a bid to meet a “growing demand” for renal trials.

Theorem and Gallus team up to help drugsmakers in emerging markets go State side

16-Aug-2012 - Theorem and Gallus say their new biologics manufacturing partnership is aimed at giving a “leg up” to drugsmakers in emerging markets looking to market products in the US.

Icon readies itself for translational medicine boom with Manchester expansion

14-Aug-2012 - Icon has boosted its Phase I translational medicine services in Manchester, UK, in preparation for what it believes will be a boom in the drug development area.

Exclusive interview

Cherry picking best functionalities is key, Bioclinca CEO tells OSP

13-Aug-2012 - BioClinica says the next eClinical revolution will be in programmes combining functionalities tailored to a client's specific needs.

EXCLUSIVE

Big Pharma looking to home care to bolster clinical activities: ResearchNurses.co

09-Aug-2012 - ResearchNurses.co will conduct home visits in clinical trials for three Big Pharma firms after forging an agreement with Nottingham University Hospitals Research and Innovation Department.

New pharma services from M&A and partnerships: round-up

07-Aug-2012 - Outsourcing-Pharma.com presents the low down on new services forged by partnerships and M&A (mergers and acquisitions), including a molecular biology offering for Quotient, Onyx’s added purification and separation capabilities, and...

Medidata beats Q2 expectations following landmark $100m contract

01-Aug-2012 - Medidata beat analyst expectations in this year’s Q2 results after inking a five-year $100m clinical cloud deal – the largest in the firm’s history.

BioFocus and Activiomics team up to boost drug candidate selection

31-Jul-2012 - BioFocus and Activiomics have teamed up to offer a drug discovery and biomarker service which it says will improve the identification of novel targets.

Payment based on CRO results is the wave of the future: iGate

30-Jul-2012 - Outcome-based payment for CRO services is the “wave of the future” for pharmaceutical outsourcing, according to iGate.

iGATE says new data management tech will change R&D

09-Jul-2012 - iGATE says its new information management platform will provide a 70 per cent decrease in content management costs for the drug development process.

EXCLUSIVE

CDMO and CRO must become one so clinical research can evolve: Quotient.

05-Jul-2012 - ‘Merge CDMO and CRO activities to fix the holes in the early phase clinical research industry’, said Quotient Clinical’s CEO Mark Egerton.

Argentina's CRO market set to boom, says report

04-Jul-2012 - Argentina’s clinical trial market will hit $76m (EUR60.4) by 2015 with growth driven by low costs, a good regulatory environment and large patient populations, according to a new study.

Over 25% of clinical trial procedures are pointless, says Medidata

02-Jul-2012 - A quarter of procedures carried out during clinical trials may be pointless according to a new study, which suggests that this unnecessary work costs around $5bn (€3.96bn) a year. ...

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