Regulatory affairs

Access to Medicines says outsourced clinical trials need to be codified

03-Dec-2012 By Gareth Macdonald

The group whose comments on sponsor oversight drew criticism from ACRO says the industry group's preferred ‘trust and verify’ model only works if verification efforts are robust.

SGS and blue inspection body to be excipact trained

29-Nov-2012 By Gareth Macdonald

The group behind the excipient certification scheme Excipact will train SGS and blue inspection body GmbH auditors under agreements signed this week.

News from PCT Europe

Post-approval service providers must collect less but more focussed data, says INC

28-Nov-2012 By Natalie Morrison

Post-approval service providers must collect less but more focussed data for successful drug launches, according to INC Research.

Pfizer could re-launch virtual trial programme as soon as 2013

27-Nov-2012 By Natalie MORRISON

Pfizer is re-jigging its failed virtual trial model and could re-launch the programme as soon as 2013.

News from CPhI

India will stamp out "fly by night operators" in trial industry, says Gov

27-Nov-2012 By Natalie Morrison

The Indian Government will stamp out “fly by night operators” in its clinical trials sector by plugging "loopholes" in the regulations.

Risk-based monitoring could simplify trial data QC, according to Annex Clinical

26-Nov-2012 By Natalie Morrison

Risk-based monitoring means certain aspects of clinical trials can be quality checked using a segment of the data, according to Annex Clinical.

News from PCT

CRA turnover in China too high: PCT discussion

21-Nov-2012 By Natalie Morrison

High CRA turnover in China often hinders trials, according to an Oxford University expert.

Medpace boost EU device offering through Meditech takeover

20-Nov-2012 By Natalie Morrison

Medpace has acquired Meditech Strategic Consulting in a bid to expand its European clinical trial services.

Boehringer set to make E.coli for clinical trials

12-Nov-2012

Molecular Partners has contracted Boehringer Ingelheim to produce a range of highly potent molecules for its clinical pipeline.

Report from PCT Europe

Is risk-based clinical trial monitoring too flexible for the regulators?

12-Nov-2012 By Natalie Morrison

Risk-based monitoring for clinical trials was a hot topic at this year’s PCT Europe thanks to recent draft guidances from the FDA and the EMA.

DISPATCHES FROM PCT EUROPE

Strategic deals fit with regulators' risk-based site monitoring

08-Nov-2012 By Natalie Morrison

Risk-based site monitoring is easier under strategic partnerships than other relationship models according to Covance.

Late phase services on rise thanks to need for "real world" data, says ISR

05-Nov-2012 By Natalie Morrison

The late phase services industry is growing thanks to a new regulatory need for more “real world” data, says ISR Reports.

News from CPhI

Penn Pharma in talks with the big boys over new facility

24-Oct-2012 By Natalie Morrison

Penn Pharma is in talks with a number of “big players” over its upcoming high containment oral solid dose facility.

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.

Dispatches from AAPS

Bend Research hunting new partnerships to boost bioavailability offering

17-Oct-2012 By Natalie Morrison

Bend Research is “actively” hunting new partnerships similar to its recent alliance with Dow.

Dispatches from AAPS

Emerging market CMOs and their customers must make info easily available: FDA

16-Oct-2012 By Natalie Morrison

Make information about generic production readily available when working with vendors in emerging markets for quicker US approval, says the FDA.

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

10-Oct-2012 By Natalie Morrison

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 By Natalie Morrison

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 By Natalie Morrison

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 By Natalie Morrison

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

Children must be included in more trials to drive paediatric development: experts

01-Oct-2012 By Natalie Morrison

Children are not included in enough clinical trials in the US, according to an FDA committee.

EXCLUSIVE STUDY

Open source paradigm could swipe biz from CROs: Beroe

27-Sep-2012 By Natalie Morrison

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

Cedarburg Hauser boosts API production capacity

26-Sep-2012 By Natalie Morrison

Cedarburg Hauser Pharmaceuticals (CHP) has increased its API plant in a bid to meet client demand.

Clinipace doubles in size after purchase of Paragon

25-Sep-2012 By Natalie Morrison

Clinipace has bought Californian CRO Paragon Biomedical in a bid to expand its therapeutic expertise.

Generics firms could pay €20m a year for pharmacovigilance says EGA

24-Sep-2012 By Gareth Macdonald

Proposed EMA pharmacovigilance fees are too high and place a disproportionate burden on generics firms according to the European Generic Medicines Association (EGA).

Quintiles makes trial management system more interactive

24-Sep-2012 By Natalie Morrison

Quintiles says it has improved its trial management services with a new navigation platform for its Infosario programme.

Cyprotex and InSphero launch predictive tox testing service using 3D micro-liver

20-Sep-2012 By Natalie Morrison

Cyprotex and InSphero have teamed up to offer predictive drug toxicity services using 3D micro-models of liver tissue.

Clinical trials should involve the elderly more, say experts

19-Sep-2012 By Natalie Morrison

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.

Quintiles signs 10-year Mexico deal with Sinclair

18-Sep-2012 By Natalie Morrison

Quintiles will commercialise Sinclair IS Pharma’s products in Mexico under a 10-year licensing agreement.

Recruitment success in biosimilar trials relies on staff training: ISR

18-Sep-2012 By Natalie Morrison

The key to improving patient recruitment in trials of biosimilar drugs is site staff training, according to ISR.

Catalent plans to bridge South Korean development gap with the West

17-Sep-2012 By Natalie Morrison

Catalent has teamed up with CTC Bio to help South Korean pharmas work in the West.

INC opens clinical facility in "promising" Korea

13-Sep-2012 By Natalie Morrison

INC Research has opened a new clinical operations facility in South Korea in a bid to grab a slice of what it says is a “promising” research market.

API production will boost contract pharma manufacturing biz

12-Sep-2012 By Natalie Morrison

Active pharmaceutical ingredient production will be the driving factor behind a predicted boom in the pharmaceutical contract manufacturing market, according to Visiongain.

Improving Biopharma R&D efficiency a mixed blessing for CROs

06-Sep-2012 By Natalie Morrison

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 By Natalie Morrison

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

Emerging market regulatory staff should take test to level playing field, RAPS

30-Aug-2012 By Natalie Morrison

Regulatory professionals working for contract research organisations (CROs) in emerging markets could benefit from taking a test to bring them up to par with those in developed countries, according to RAPS.

EXCLUSIVE

GSK and AstraZeneca attracted by NHS' efforts to work with sponsors and CROs outside UK

29-Aug-2012 By Natalie Morrison

GlaxoSmithKline (GSK) and AstraZeneca have been attracted by NHS efforts to work with sponsors and CROs outside the UK according to Government investment group, UK Trade and Investment.

BE/BA sites must be logged with US FDA under GDUFA

28-Aug-2012 By Gareth Macdonald

CROs conducting bioequivalence and bioavailability (BE/BA) studies for generics firms will have to log details of their sites with the US FDA under new ‘self-identification’ rules.

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

23-Aug-2012 By Natalie Morrison

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 needed in the launch.

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

21-Aug-2012 By Natalie Morrison

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 By Natalie Morrison

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 By Natalie Morrison

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.

Exclusive Research

India's inexpensive biostatistics outsourcing market set to boom: Beroe

13-Aug-2012 By Natalie Morrison

India’s biostatistics outsourcing market is set to grow 15 per cent in two years thanks to a 50 per cent cost saving compared with the West, according to a new survey.