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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.

Quintiles: Africa is the next drug development frontier

21-Sep-2009 - Quintiles has targeted Africa as the next non-traditional area to develop new medicines and the opening of its office in Ghana, which is now fully operational, is a major step...

Bill aims to boost recruitment for rare disease clinical trials

18-Sep-2009 - Recruiting patients with rare diseases for clinical trials could become easier if the US Congress passes a bill to allow patients on supplemental security income (SSI) benefits to receive compensation.

Orasi service aims to cuts costs in Alzheimer’s trials

16-Sep-2009 - Orasi Medical claims CROs and pharmas can cut the cost and length of Alzheimer’s trials, and improve accuracy, by using its brain function measuring service, which is now being promoted...

CRO reputation vital when selecting outsourcing partner; CEO

16-Sep-2009 - Outsourcing to a well known CRO with a good reputation is vital to ensuring that data is well received by regulatory authorities, according to a CEO that just inked a...

Xybion and Locus team up on animal and preclinical data management

15-Sep-2009 - US firms Xybion Medical Systems and Locus Technology say their new animal management and data analysis partnership will help streamline preclinical development and reduce research costs.

Ghostwriting widespread in 6 of top 10 med journals; study

14-Sep-2009 - A significant number of articles in six of the top 10 medical journals in 2008 were ghostwritten, according to study by editors of JAMA that found responding authors reported a...

Warning letters increase as DSI rejigs operations

09-Sep-2009 - FDA warning letters to clinical trial investigators have increased by 50 per cent in 2009 as a consequence of improved processes at DSI, a spokesperson told Outsourcing-Pharma.

Lab Research lands new preclinical R&D contracts

09-Sep-2009 - New multi-million dollar R&D contracts with top three pharma and biotech players go someway to “alleviating” the negative impact of downturn, according to Lab Research CEO Luc Mainville.

Report recommends FDA revises postmarketing processes

04-Sep-2009 - Following a review of the backlog of postmarketing studies the FDA has initiated changes to improve its processes, including developing Manuals of Policies and Procedures (MAPP) to track the status...

Indian registered clinical trials soar

03-Sep-2009 - Clinical trials registered in India have soared in the past 12 months, as the nation has shifted its policy on recording full study details from voluntary to advisory and in...

Pfizer and Private Access team up for trial recruitment website

20-Aug-2009 - US drug giant Pfizer has joined the growing list of organisations seeking to boost trial recruitment via the web, teaming up with IT firm Private Access to create a website...

Scrutiny of publication bias increases

20-Aug-2009 - Bias in publications in medical journals is facing intense scrutiny again, following media reports GSK used a ghostwriting programme and separate research into combating the problem.

FDA strengthens disqualify & debar actions

10-Aug-2009 - The US Food and Drug Administration (FDA) has enhanced its debarment and disqualification procedures to ensure clinical trial investigators meet legal requirements.

Ecron Acunova teams up with Essential CRO and Biotrial

03-Aug-2009 - Ecron Acunova’s global partnering team had a busy end to July with the Indian CRO entering into collaboration deals on both sides of the Atlantic to further expand its global...

Developing world trials meet standards and speed drugs to market, says ACRO

22-Jul-2009 -  Clinical trials in the developing world meet the same standards as those in Europe and the US and are vital for accelerating drug development says the Association of Clinical Research...

KDH hopes PatientLocate will change recruitment paradigm

09-Jul-2009 -  US software development firm KDH Systems has unveiled a new platform that it claims will change “the paradigm of clinical trial patient recruitment.”

India vs China: outsource what to where

07-Jul-2009 -  India and China share many similarities as outsourcing locations but there are also significant differences that are important to understand before making a commitment, according to a report.

MDS expands Taiwan capacity in early stage focus

09-Jun-2009 -  MDS Pharma Services is renovating and expanding its Taiwanese discovery pharmacology operation in response to growing global demand for work performed in Asia.

PRA opens drug safety centre in Brazil

01-Jun-2009 -  PRA International has opened a drug safety centre in São Paulo, Brazil, expanding its presence in Latin America and bringing its array of services to a new market.

Global trials call for global ethics, says NEJM study

14-May-2009 -  The increasingly global clinical trial sector demands more effective ethical and regulatory scrutiny according to a study published in the latest edition of the New England Journal of Medicine (NEJM)....

NJ slams FDA on conflicts of interest

14-May-2009 -  New Jersey’s attorney general has called on the FDA to stop the “rampant undisclosed financial conflicts of interest” in clinical trials.

Cisiv launches Baseline Plus for "real world" trials

07-May-2009 - UK software group Cisiv has unveiled a web-based EDC platform, Baseline Plus, which is specifically tailored to meet the demands of post market trials.

Coast IRB closes doors after GAO sting

27-Apr-2009 - Coast IRB has decided to close after a probe by US Government Accountability Office (GAO) and subsequent FDA warning letter resulted in the loss of “several key customers”.

Mandatory registration for Indian clinical trials

17-Apr-2009 -  From June onwards drug firms and CROs conducting trials in India are required to record full details of the research, including the funding source, on the ICMR’s Clinical Trials Registry...

MWV expands blister pack range with Shellpak-170

16-Apr-2009 -  US contractor MeadWestvaco (MWV) claims the latest addition to its Shellpack range, the Shellpak-170, offers drugmakers more options for adherence promotion blister packaging. 

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