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Patient safety

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.

AAHRPP revises standards

01-Oct-2009 - The AAHRPP has issued a major revision of its standards, the first time it has done so, adding sections on transnational research and the separation of business interests from ethics...

FDA issues cancer vaccine trial guidance

30-Sep-2009 - Clinical trials of cancer vaccines should enrol patients with no evidence of residual disease, according to FDA guidance, but this will increase development times compared to cytotoxic agents.

WHO endorses African clinical trial registry

28-Sep-2009 - The Pan-African Clinical Trials Registry (PACTR) has become the first such database to be endorsed by the WHO, providing the world with access to studies on the continent and improving...

FDA EOP2A guidance aims to boost trial success

23-Sep-2009 - The FDA is hoping to increase the likelihood of a clinical trial being successful by making best use of science and alternative study designs and has issued end-of-Phase IIa (EOP2A)...

CROs alter IRB selection policies after GAO sting; VP

23-Sep-2009 - The GAO sting operation and subsequent increased scrutiny will “definitely change how pharma and CROs choose IRBs”, according to the VP of NEIRB who spoke to Outsourcing-Pharma after successfully completing...

Sentinel Initiative will help with postmarketing objectives; PRA

22-Sep-2009 - The Sentinel Initiative will help pharma and CROs pinpoint study objectives, according to a director at PRA who told Outsourcing-Pharma about the company’s postmarketing safety surveillance.

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.

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