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14 April 2011

This is fantastic, now we can have both text and image content on the top of the page and not as Breaking news but as a Highlight!

 
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 ...
Debiopharm inks deal with INC Research
26 July 2011
The CRO INC Research has formed a strategic partnership with Swiss biopharmaceutical company Debiopharm , which will see the CRO manage a clinical study for Debio 0932, while both have agreed a framework for INC's collaboration on future trials. INC Research will be firstly working on a trial for ...
 
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 ...
Debiopharm inks deal with INC Research
26 July 2011
The CRO INC Research has formed a strategic partnership with Swiss biopharmaceutical company Debiopharm , which will see the CRO manage a clinical study for Debio 0932, while both have agreed a framework for INC's collaboration on future trials. INC Research will be firstly working on a trial for ...
Icon rejects Pfizer's Sandwich, but is hungry for 800 of its staff
21 July 2011
In a Q2 earnings call with analysts, Icon CEO Peter Gray made it clear that the CRO will not take on Pfizer 's facility in Sandwich, UK, as part of the preferred partnership deal it signed with the pharmaceutical giant at the end of May, that will see the research sponsor cull its strategic ...
 
EndPoint: Dan Weng
28 February 2011
Dr Dan Weng is Medpace 's new vice-president of operations in Asia, the Pacific Rim, Latin America and South Africa (its 'Rest of World' segment). He is charged with driving the firm's growth in emerging markets. Weng, a graduate of China's Tongji Medical University , has more than 25 years of ...
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 ...
The Socialist Republic of Vietnam: an emerging arena
10 January 2011
Vietnam is a country with a population of 89 million. It is one of Southeast Asia's fastest-growing economies and aims to become a developed nation in ten years time. Informa principal analyst Phil Greenfield finds out that the country's plans to grow the clinical trials market are no less ...
A tale of two patients
08 October 2010
When David Hall felt his energy levels fall it was a surprise to him, but to be expected given his recent experiences. A man in his late seventies, he had been active and energetic all his life. However, he had been diagnosed with prostate cancer in 1998 and his wife had been diagnosed with ...
 
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 ...
 
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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