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LATEST NEWS
Cetero lashes back at FDA misconduct claims which "discredit" employees
28 July 2011
The US CRO Cetero Research has hit back at recent US FDA claims of data falsification at its Houston laboratory, calling the action "difficult to understand" since the CRO raised the issue with the FDA in the first instance. The FDA released the results of two inspections of Cetero's bioanalytical ...
FDA warns CRO-falsified data may undermine drug approvals
28 July 2011
Pharmaceutical companies that used the services of the CRO Cetero Research at its Houston laboratory to carry out bioanalytical studies between April 2005 and June 2010 have been advised to reassess these test results after "significant areas of misconduct" were found by US FDA inspectors at the ...
BrainStorm hires PharmaNet to get FDA ALS clinical trial approval
26 July 2011
The CRO PharmaNet is to help BrainStorm Cell Therapeutics , a developer of adult stem cell technologies and CNS therapeutics, to develop the protocol and IND file for submission to the US FDA for approval to conduct amyotrophic lateral sclerosis (ALS) clinical trials in the US. BrainStorm has been ...
Mytrus secures rights to clinical trial internet patent from Boston University
23 June 2011
The San Francisco-based software firm Mytrus has bought the exclusive rights to Boston University 's patented method for managing clinical trials over the internet from one single co-ordinating centre, enabling them the competitive advantage to offer clients a completely protected study performed ...
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FEATURES
Serbia emerging as a major player in CEE
12 January 2011
Serbia has emerged from its recent troubles as one of the most desirable clinical trials destinations in the CEE region, building on the former Yugoslavia’s reputation as a GCP-compliant, multicentre research base and strong pharmaceutical industry. Informa principal analyst Phil Greenfield takes a ...
Reviving the Japanese clinical trial system
21 January 2010
Japan is one of a few countries that develop innovative medicine for patients globally and as in other countries, such as America and China, Japan has some unique regulatory requirements for conducting its clinical trials. In 1996 the ICH-GCP standards were agreed across Japan, the US and the EU, ...
A Gateway to Turkey
29 October 2009
Turkey is rapidly becoming become one of the most important geographical regions for technology R&D, particularly for the pharmaceutical sector. In recent years, R&D activities in Turkey have been on the increase, due mostly to its highly educated young population, its vast labour force and ...
Tightening standards in a shrinking world
01 October 2009
The worldwide regulatory landscape for clinical trials has been undergoing a period of profound change and the present year has seen regulatory bodies maintain their focus on the global harmonisation of regulatory standards and increased scrutiny of those companies conducting trials. Regulatory ...
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PEOPLE
Biotec hires project managers to support growth
The clinical trials supply company Biotec Services International , has appointed two new project managers to strengthen the company’s expanding team. Clare Aubrey and Nicola Jenkins have been tasked with dealing with the increasing number of studies which are being undertaken by Biotec, which will ...
PharmaNet's Maida joins OncoSec board
OncoSec Medical , a therapeutic oncology company developing its advanced-stage ElectroOncology therapies to treat solid tumour cancers, has appointed Dr Anthony Maida to its board of directors and chair of its audit committee. Dr Maida was most recently vice-president of clinical research and ...
CRO veteran joins Waife & Associates
Waife & Associates , change management consultants in clinical research, has appointed Mark Di Ianni , of MDI Consulting Services , to head up its service provider management practice. Di Ianni has been a senior executive in the CRO industry for 30 years, founding and/or managing a series of ...
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COMMENTARY
Portfolio strategies for maximum effect
If your company is fortunate enough to have multiple projects in your development pipeline, and assuming that you do not have an unlimited resource pool, then you will be faced with some critical choices as to which projects to support and which projects not to support. Support of a project ...
ICH-GCP: older but perhaps not wiser
The ICH Harmonised Tripartite Guideline for Good Clinical Practice E6(R1), to give it its full name, was adopted in Europe in 1996 (and in the US and Japan the following year). The aim of ICH-GCP is to provide a unified standard for the EU, the US and Japan to facilitate the mutual acceptance of ...
Breathing new life into the COPD market
Chronic obstructive pulmonary disease (COPD) is an umbrella term that refers to chronic lung diseases that share the common feature of restricted airflow. According to the most recent estimates from the WHO, there are currently 210 million COPD patients worldwide, of whom 80 million have moderate ...
Prevention is better than cure
Safety concerns are never far from view where pharmaceutical R&D is concerned. Early pre-clinical testing helps to determine whether a new substance is likely to cause serious adverse events in humans, and whether it should be progressed to clinical trials. While this has been the case for many ...
Excellence in site identification begins at home
We are all aware of a sponsor’s requirement to select investigators who are, as it states in the US Code of Federal Regulations, "qualified by training and experience as appropriate experts to investigate the drug" 1 in accordance with good clinical practices. However, the current competitive ...
Acne market fails to excite
Acne, the scourge of teenagers, is a chronic condition associated with blockage of the pilosebaceous ducts typically on the face, chest and back. The blockage is manifested as a comedo or ‘blackhead’ – the pigmentation is caused by melanin arising from the hair. In cases with more severe blockage ...
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