Regulatory affairs

iGATE says new data management tech will change R&D

09-Jul-2012 By Natalie Morrison

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 By Natalie Morrison

‘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 By Natalie Morrison

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.

EU defends trials directive but commits to make process faster and more efficient

03-Jul-2012 By Gareth Macdonald

European laws on clinical trials need to be faster and more efficient but they are not the only reason for the decline in the sector according to EU health and consumer policy commissioner John Dalli.

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

02-Jul-2012 By Natalie Morrison

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. 

UPDATE

New draft guidance on clinical trial insurance in the UK to accelerate ethics committees, says Government

02-Jul-2012 By Natalie Morrison

A new draft guidance stating the level of insurance cover required for trial participants in the UK will accelerate ethics committees’ approval process, according to experts.

US base will bridge gap for manufacturing in China, says Suzhou pharma

27-Jun-2012 By Natalie Morrison

China-based Suzhou Pharma has set up a US regulatory and QA hub in what it says is a bid to provide Western cGMP (current good manufacturing practice) know-how with low cost Asian production.

UPDATE

UPDATES from DIA 2012: "Collaborate to innovate," says the association

27-Jun-2012 By Natalie Morrison

“Collaborate to innovate,” is the message DIA has for clinical researchers at its 2012 Annual Meeting in Philadelphia, US.

UPDATE

Quintiles boosts lab testing in China

21-Jun-2012 By Natalie Morrison

Quintiles has teamed up with the Shanghai Clinical Research Centre (SCRC) to ramp-up its biopharmaceutical lab testing services in China.

Trial regulation in emerging markets is now "too stringent," says new report

14-Jun-2012 By Natalie Morrison

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.

Almac launches on-site QP consultation service

14-Jun-2012 By Gareth Macdonald

Almac has come up with a variation on the QP consulting business with a new service that provides on-site oversight.

PRA focuses on late phase services

31-May-2012 By Natalie Morrison

PRA has expanded its operations in the Netherlands and the UK in a bid to meet what it says is soaring client demand for late phase and product registration services.

EXCLUSIVE

Home visits = regulatory thumbs up? ResearchNurses.co thinks so

31-May-2012 By Natalie Morrison

The use of home visits in clinical trials could raise the chances of regulatory approval, according to ResearchNurses.co.

EXCLUSIVE

Chiltern CEO reflects on 30 years in the CRO biz

28-May-2012 By Natalie MORRISON

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 By Natalie Morrison

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 By Natalie Morrison

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 By Natalie Morrison

Quanticate says it will eliminate unnecessarily “complicated spreadsheets” in clinical trial data analysis after integrating a new simplified web-based program into its own.

Know how your CMO will deliver its promises, says Baxter

09-May-2012 By Natalie Morrison

“Understand not only what your CMO can do, but how they can get it done,” was Baxter’s message during a speech at the year’s Interphex in New York.

AmerisourceBergen sees Q2 revenue growth

30-Apr-2012

AmerisourceBergen’s commercial services arm was its key driver in Q2, offsetting the loss of key customer for its drug business.

Once a friend now an enemy: Over zealous EU regulators could hamper the CMO market, says analyst

25-Apr-2012 By Natalie Morrison

The European CMO industry could be blocked by over complex layers of regulation, says Frost & Sullivan analyst Aiswariya Chidambaram.

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

12-Apr-2012 By Natalie Morrison

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

Regulatory changes: the experts give us their thoughts at DIA Euromeeting

05-Apr-2012 By Natalie Morrison

Regulatory reform was the name of the game at this year’s DIA Euromeeting in Denmark.

Catalent eyes emerging market expansion of end-to-end development service model

04-Apr-2012 By Natalie Morrison

Catalent wants to build on its European expansions by replicating the end-to-end drug development services model in emerging markets. 

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

29-Mar-2012 By Natalie Morrison

“Less bureaucracy and more research” was the Danish Minister of science and innovation’s message to regulators at this week's DIA Euromeeting.

Selecting formulation early cuts time to market, says Formac

21-Mar-2012 By Natalie Morrison

Formac Pharmaceuticals and WR Grace say their silica platform can improve the formulation selection process for poorly soluble APIs (active pharmaceutical ingredients).

European CMO market will double in just 6 years, says Frost & Sullivan

15-Mar-2012 By Natalie Morrison

The European CMO sector is set to double in the next six years and will hit revenues of up to $20.75bn, according to Frost & Sullivan’s Aiswariya Chidambaram.

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

12-Mar-2012 By Natsalie Morrison

The two Indian CROs implicated in US TV show Dateline’s recent undercover operation have branded the report “unfair” and “out of context”.

Celerion and Ricerca team up with one-stop-shop services for biosimilars

01-Mar-2012 By Natalie Morrison

Celerion and Ricera Biosciences have launched a new joint venture to provide a cost-cutting one-stop-shop solution for companies developing and commercialising biosimilars.

EXCLUSIVE

Social networking is key to trial recruitment success, says expert

27-Feb-2012 By Natalie Morrison

Pharma companies must become more involved in building patient communities through social media if they want to see a successful trial recruitment process according to Patient Nucleus founder Jamie Blackburn.

Frontage expands CMO consultancy offering in China

22-Feb-2012 By Natalie Morrison

Frontage Laboratories says it is focussing on improving regulatory and GMP compliance in China after signing a $10m (€7.5m) collaboration with drugs maker Fanghui Pharma.

Ockham buys Nexus in bid to boost oncology trial offering

15-Feb-2012 By Natalie Morrison

Ockham has expanded its oncology trial services offering through its acquisition of Nexus Oncology.

Contract manufacturing round-up

26-Jan-2012 By Natalie Morrison

Outsourcing-Pharma presents a round-up of the latest headlines within the world of contract manufacturing. Catalent and Patheon have each launched oral dosage partnership news, whilst Frontage and AMPAC have received regulatory go-aheads.

CFS plans to tackle financial management diversity in different countries through expansion

25-Jan-2012 By Natalie Morrison

Clinical Financial Services (CFS) has made its first foray into the global market after opening a new office in Edinburgh, Scotland.

Language skills and local knowledge a must for BPO success in Asia says Quintiles

23-Jan-2012 By Gareth Macdonald

Multilingual ‘magic’ and cultural knowledge are the keys to business process outsourcing (BPO) success in North Asia according to Quintiles.

NSF moves into medical device trial training

18-Jan-2012

Training and consultancy firm NSF Health Sciences (NSF-DBA) has acquired Pink Associates in a bid to broaden its service offering.

FDA group calls for industry to submit draft guidance docs

04-Jan-2012 By Nick Taylor

The FDA should encourage industry to submit draft guidance to speed regulatory development, an agency working group found.

Asian CROs form alliance, stressing benefits of local knowledge

15-Dec-2011 By Gareth Macdonald

Six Asian CROs have set up a regional network and claim their local knowledge will make conducting clinical trials in the region more straightforward.

CNS launches custom-fit regulatory consulting service

06-Dec-2011 By Natalie Morrison

Clinical Network Services (CNS) has launched its new custom-fit regulatory consulting service, BioDesk.

Personalised med developers must engage payers earlier; UBC

05-Dec-2011 By Nick Taylor

UBC & Medco are calling for personalised medicine developers to engage payers in Phase I to ensure necessary data is generated.

Rise of Asian biopharm creates investment targets for Quintiles

01-Dec-2011 By Nick Taylor

Quintiles expects to make more investments in Asia-Pacific partnerships as the local biopharm sector grows.

UBC looking to ‘buy or build’ to serve strategic partnerships

29-Nov-2011 By Nick Taylor

UBC expects strategic outsourcing of outcomes and personalised medicine research to accelerate as biopharm cut fixed costs.

Indian trial compensation guidelines open to comment

28-Nov-2011 By Nick Taylor

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

Establishing R&D bonds is wave of the future, says Lilly boss

08-Nov-2011 By Natalie Morrison

Drug researchers must integrate development programs more to drive the industry into the 21st century, says Eli Lilly CEO John Lechleiter.

FDA plans QbD for clinical trials to cut industry & regulatory monitoring costs

24-Oct-2011 By Nick Taylor

The FDA is working on quality-by-design (QbD) for clinical trials to cut oversight costs for industry and regulators.

SFDA hand cash to CMO whistleblowers

17-Oct-2011 By Natalie Morrison

The Chinese Food and Drug Administration (SFDA) plans to ramp up cash rewards for whistleblowers who flag illegal goings on within the Chinese drugs manufacturing sector.

Competitive concerns limit market access outsourcing

12-Oct-2011 By Nick Taylor

Outsourcing of certain market access tasks is limited by concerns that using vendors will give rivals a competitive advantage, a report found.

Pearl IRB to launch new consulting and regulatory compliance divisions

04-Oct-2011

Clinical trial monitoring firm Pearl IRB will launch compliance and consulting services in response to customer demand.

DaVita launches FDA advisory committee prep service

29-Sep-2011

DaVita Clinical Research will help sponsors prepare for US FDA advisory committee meetings through a new contract offering introduced this week.

Social media is a must in patient recruitment, say PRO panelists

28-Sep-2011 By Nick Taylor

Early adopters are effectively using social media for patient recruitment and retention but in general the industry is fearful, a panelist at Patient Recruitment Outsourcing (PRO) 2011 said.

WHO adds EU registry to clinical trial database

28-Sep-2011 By Alexandria Pesic

The EU Clinical Trials Register (EU-CTR) has been formally recognised by the World Health Organization (WHO) as one of the primary registries for its International Clinical Trials Registry Platform (ICTRP).